Small Cell Lung CancerPhase 1NCT03116971
Phase Ib/II Study of M3814 With Etoposide and Cisplatin in Small Cell Lung Cancer (SCLC) Extensive Disease (ED)
A Phase 1 study testing M3814, Cisplatin and Etoposide in people with Small Cell Lung Cancer, run by EMD Serono Research & Development Institute, Inc. at 80 sites in 13 countries.
Trial summary
M3814 is an investigational drug under evaluation for treatment of lung cancer. The purpose of the study was to assess the Safety and Efficacy of M3814 in combination with chemotherapy with SCLC ED. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer
- What is being tested?
- M3814, Cisplatin and Etoposide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 80 sitesin 13 countries
- Study dates
- 25 May 2017to 1 Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for the study (Phase Ib and Phase II) the participant must fulfill all of the following criteria:
- Male or female participants at least 18 years of age
- Histological or cytological diagnosis of SCLC
- Extensive disease (ie, disease beyond ipsilateral hemithorax, which may include malignant pleural or pericardial effusion or hematogenous metastases [Tany, Nany, M1a/b; T3-T4, Nany, M0, due to multiple lung nodules or extent of disease that precludes a tolerable radiation field, as judged by the Investigator])
- Participants eligible for first line platinum-based chemotherapy
- Measurable or evaluable disease according to RECIST v1.1
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- Eastern Cooperative Oncology Group performance status (ECOG PS) less than equals to (<=) 2
- Life expectancy of greater than equals to (≥) 3 months
- Female participants of childbearing potential and male participants with female partners of childbearing potential must be willing to avoid pregnancy Note: Other protocol defined criteria could apply.
Who cannot join
- Participants are not eligible for the study if they fulfill any of the following exclusion criteria:
- Prior anticancer therapy for extensive disease (ED) SCLC including experimental agents.
- Concurrent use of other anticancer therapy including any investigational agent within 28 days prior to the first dose of the investigational drug M3814.
- Extensive prior radiotherapy (RT) on more than 30% of bone marrow reserves (by Investigator judgment)
- Prior bone marrow/stem cell transplantation within 5 years before study start (Phase II only)
- Major surgical intervention within 28 days prior to the first dose of investigational drug administration. Intervention(s) to establish the diagnosis for SCLC is permitted within 28 days as long as participants are cleared by the medical and surgical teams.
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- Poor vital organ functions defined as:
- Bone marrow impairment as evidenced by hemoglobin less than (<) 9.0 gram per deci liter (g/dL) (5.7 micromole per liter (μmol/L)), absolute neutrophil count < 1.5 × 109/L, platelets < 100 × 109/L
- Renal impairment as evidenced by calculated creatinine clearance < 60 mL/minutes (min) (according to the Cockcroft-Gault formula)
- Liver function abnormality as defined by total bilirubin greater than (>) 1.5 × upper limit of normal (ULN) or aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 2.5 × ULN (participants with liver involvement: a maximum of AST/ALT 5 × ULN)
- Contraindication to the use of etoposide or cisplatin
- Participants currently receiving (or unable to stop using prior to receiving the first dose of investigational drug) medications or herbal supplements known to be potent inhibitors of cytochrome P450 (CYP) 3A and CYP2C19 (unless treatment can be discontinued at least 1 week prior to receiving the first dose of investigational drug) or potent inducers of CYP3A and CYP2C19 (unless treatment can be discontinued at least 3 weeks prior to receiving the first dose of investigational drug). Note: Other protocol defined criteria could apply.
Trial locations and contacts
80 sites in 13 countries.
80 sites in 13 countries
United States16 sites
Research site
Ashland, Kentucky, 41101
Research site
Billings, Montana, 59101
Research site
Cincinnati, Ohio, 45229
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Columbus, Georgia, 31904
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Danbury, Connecticut, 06810
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Houston, Texas, 77030
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Mesa, Arizona, 85206
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Newnan, Georgia, 30265
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Norwalk, Connecticut, 06850
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Philadelphia, Pennsylvania, 19124
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Pinehurst, North Carolina, 28374
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Portland, Oregon, 97213
Research site 1
Santa Rosa, California, 95403
Research site
Santa Rosa, California, 95403
Research site
Topeka, Kansas, 66606
Research site
Whittier, California, 90603
Germany9 sites
Research site 1
Berlin, 10117
Research site 2
Berlin, 10967
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Chemnitz, Saxony, 9113
Research site
Freiburg im Breisgau, Baden-Wurttemberg, 79106
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Gauting, Bavaria, 82131
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Hanover, Lower Saxony, 30625
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Kiel, Schleswig-Holstein, 24105
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Lübeck, Schleswig-Holstein, 23538
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Nuremberg, Bavaria, 90419
Belgium8 sites
Research site
Aalst, 9300
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Charleroi, 6000
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Edegem, 2650
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Ghent, 9000
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Libramont, 6800
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Liège, 4000
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Roeselare, 8800
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Yvoir, 5530
Italy8 sites
Research site
Catania, 95123
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Genova, 16132
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Naples, 80131
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Ravenna, 48121
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Reggio Emilia, 42100
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Roma, 168
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Rozzano, Milano, 20089
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Torino, 10126
Bulgaria6 sites
Research site 4
Sofia, 1330
Research site 2
Sofia, 1407
Research site 6
Sofia, 1431
Reasearch site 5
Sofia, 1527
Research site 3
Sofia, 1632
Research site 1
Sofia, 1784
Hungary6 sites
Research site 1
Budapest, 1121
Research site 2
Budapest, 1121
Research site 3
Budapest, 1125
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Farkasgyepű, 8582
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Szekszárd, 7100
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Szolnok, 5000
Romania5 sites
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Baia Mare, 430291
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Cluj-Napoca, 400015
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Cluj-Napoca, 400058
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Craiova, 200347
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Timișoara, 300210
Spain5 sites
Research site
Badajoz, 6080
Research site 1
Madrid, 28040
Research site 4
Madrid, 28040
Research site 3
Madrid, 28046
Research site 2
Madrid, 28050
Canada4 sites
Research site
Calgary, Alberta, T2N 4N2
Research site
London, Ontario, N6A 5W9
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Saint John, New Brunswick, E2L 4L2
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Toronto, Ontario, M5G 2M9
Poland4 sites
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Olsztyn, 10-357
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Poznan, 60-569
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Warsaw, 02-781
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Wodzisław Śląski, 44-300
United Kingdom4 sites
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Glasgow, Strathclyde, G12 OYN
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Hull, East Riding Of Yorkshire, HU16 5JQ
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London, Greater London, W1G 6AD
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Sheffield, South Yorkshire, S10 2SJ
Denmark3 sites
Research site
Aalborg, 9100
Research site
Herlev, 2730
Research site
Odense C, 5000
About this study
Official title: A Multicenter Study With an Open Label Phase Ib Part Followed by a Randomized, Placebo-controlled, Double-blind, Phase II Part to Evaluate Efficacy, Safety, Tolerability, and PK of M3814 in Combination With Etoposide and Cisplatin in Subjects With Treatment-naïve Small Cell Lung Cancer (SCLC) Extensive Disease (ED)
M3814 is an investigational drug under evaluation for treatment of lung cancer. The purpose of the study was to assess the Safety and Efficacy of M3814 in combination with chemotherapy with SCLC ED.
Read the detailed description
The study was intended to be a phase I/II trial, but the study never moved forward to Phase II due to recruitment challenges.
- Conditions
- Small Cell Lung Cancer
- Keywords
- M3814, Small Cell Lung Cancer (SCLC), Deoxyribonucleic acid-dependent protein kinase inhibitor, Chemotherapy
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M3814Drug
Also called MSC2490484A, Peposertib
Participants received M3814 PiC or hot melt extrusion (HME) tablet orally once daily in combination with etoposide (intravenously) and cisplatin for 6 cycles with each cycle lasting 3 weeks (21 days).
CisplatinDrug
Cisplatin 75 milligram per square meter (mg/m^2) was administered over a 60-minute intravenous infusion on Day 1.
EtoposideDrug
Etoposide 100 mg/m^2 over a 60 minute IV infusion on Days 1-3 was administered for 6 cycles with each cycle lasting 3 weeks (21 days).
| Study group | Role | What they receive |
|---|---|---|
| M3814 PiC with Etoposide and Cisplatin | Experimental | Participants received M3814 100 milligram (mg) powder in capsule (PiC) orally once daily in combination with Etoposide 100 mg/m^2 over a 60 minute intravenous infusion on Days 1-3 and Cisplatin 75 milligram per square meter (mg/m^2) over a 60-minute intravenous infusion on Day 1 for 6 cycles with each cycle lasting 3 weeks (21 days) until progressive disease (PD). Receives: Drug: M3814; Drug: Cisplatin; Drug: Etoposide |
| M3814 (HME Tablet + PiC) with Etoposide and Cisplatin | Experimental | Participants received M3814 100 mg hot melt extrusion (HME) tablet orally 5 days prior to Day 1 and M3814 100 mg PiC, orally once daily from Day 1 in combination with Etoposide 100 mg/m^2 over a 60 minute intravenous infusion on Days 1-3 and Cisplatin 75 mg/m^2 over a 60-minute intravenous infusion on Day 1 for 6 cycles with each cycle lasting 3 weeks (21 days) until PD. Receives: Drug: M3814; Drug: Cisplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib: Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period.
Measured: up to 21 days
Phase Ib: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of M3814 in Combination With Cisplatin and Etoposide for the Phase II Part of the Study
Measured: up to 11 months
Phase II: Progression Free Survival (PFS) as Assessed by the Investigator according to RECIST v1.1
PFS time will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause.
Measured: Time from randomization to first assessment of disease progression or death, whichever is earlier, assessed up to 24 months
Secondary outcomes (47)
Phase Ib: Number of Subjects with of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths
An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
Measured: From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment
Phase Ib: Number of Subjects with Abnormal Laboratory Values, Abnormal Vital Signs and Abnormal Electrocardiograms (ECGs)
Subjects will be analyzed for vital signs (eg, body temperature, respiratory rate, heart rate, and blood pressure), laboratory parameters and 12-lead ECG recorded at baseline and after administration of M3814. Number of subjects with abnormal values for laboratory values, vital signs and electrocardiograms (ECGs) will be reported.
Measured: From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment
Phase Ib: Change in Eastern Cooperative Oncology Group performance status (ECOG PS)
Measured: From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment
Phase Ib: Percentage of Subjects with Objective Response (OR) According to RECIST v1.1
The Objective Response Rate (ORR) is defined as the percentage of subjects whose Best objective response (BOR) is either complete response (CR) or partial response (PR). The ORR will be derived from the BOR according to response evaluation criteria in solid tumors (RECIST) v1.1 as assessed by the Investigator.
Measured: Post randomization with period tumor evaluations until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy, assessed up to 11 months
Phase Ib: Duration of Response (DoR) According to RECIST v1.1
The DoR applies only to subjects whose BOR is either CR or PR. The duration is measured from the first documented response (CR or PR, whichever is first recorded) until the first assessment of Progressive Disease (PD).The DoR will be derived from the BOR according to RECIST v1.1 as assessed by the Investigator.
Measured: First documented complete response or partial response, whichever is first recorded until the first assessment of disease progression, assessed up to 11 months
Phase Ib: Percentage of Subjects With Disease Control
Percentage of subjects with disease control as assessed by best overall response of either CR, PR or Stable Disease (SD) will be reported.
Measured: First documented complete response or partial response, whichever is first recorded until the first assessment of disease progression, assessed up to 11 months
Phase Ib: Progression Free Survival (PFS) According to RECIST v1.1
The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause. The PFS will be derived according to RECIST v1.1 as assessed by the Investigator.
Measured: Time from randomization to first assessment of disease progression or death, whichever is earlier, assessed up to 11 months
Phase Ib: Overall Survival (OS)
The OS time is defined as the date from randomization to death due to any cause.
Measured: Time from randomization to death due to any cause, assessed up to 11 months
Phase Ib: Area under the concentration-time curve from 0 to 4 hours (AUC 0-4), 0 to 24 hours (AUC 0-24) for M3814, Cisplatin and Etoposide
Measured: Day (D) -1, Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose, C3D1 Pre-dose and 3.5 hrs post dose
Phase Ib: Area Under the Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUC 0-t ) for M3814, Cisplatin and Etoposide
Measured: Day (D) -1, Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Phase Ib: Maximum Observed Plasma Concentration (Cmax) for M3814, Cisplatin and Etoposide
Measured: Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post-dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post-dose, C2D3 Pre-dose
Phase Ib: Time to Reach Maximum Plasma Concentration (Tmax) for M3814, Cisplatin and Etoposide
Measured: Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post-dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post-dose, C2D3 Pre-dose
Phase Ib: Apparent Terminal Half-life (t1/2) for M3814
Measured: C1D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hours (hrs) post-dose
Phase Ib: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of M3814
Measured: C1D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hours (hrs) post-dose
Phase Ib: Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of M3814
Measured: Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post-dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post-dose, C2D3 Pre-dose
Phase Ib: Intravenous (IV) Clearance (CL) of Cisplatin and Etoposide
Measured: Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hr post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Phase Ib: Apparent Volume of Distribution Following Extravascular Administration (Vz/f) of M3814
Measured: Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Phase Ib: Apparent Volume of Distribution (Vz) of Cisplatin and Etoposide
Measured: Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Phase Ib: Terminal rate constant (λz) for M3814, Cisplatin and Etoposide
Measured: Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Phase Ib: Changes in Cmax for M3814 Between Day -1 and C2D1
Measured: Day (D) -1, Cycle (C) 2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose
Phase Ib: Changes in AUC for M3814 Between Day -1 and C2D1
Measured: Day (D) -1, Cycle (C) 2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose
Phase Ib: Changes in AUC for Etoposide From C1D1 to C1D2, C1D3, and C2D1 (for the first 2 dose levels), or From C1D1 to C2D1 (other dose levels)
Measured: Day (D) -1, Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose
Phase Ib: Changes in Cmax for Etoposide From C1D1 and C2D1
Measured: Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose
Phase Ib: Changes in AUC for Cisplatin From C1D1 to C1D2, C1D3, and C2D1 (for the first 2 dose levels), or From C1D1 to C2D1 (other dose levels)
Measured: Day (D) -1, Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose
Phase Ib: Changes in Cmax for Cisplatin From C1D1 and C2D1
Measured: Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose
Phase II: Overall Survival (OS)
Measured: Time from randomization to death due to any cause, assessed up to 24 months
Phase II: Percentage of Subjects with Objective Response (OR) According to RECIST v1.1
The Objective Response Rate (ORR) is defined as the proportion of subjects whose Best objective response (BOR) is either complete response (CR) or partial response (PR). The ORR will be derived from the BOR according to response evaluation criteria in solid tumors (RECIST) Version 1.1 as assessed by the Investigator.
Measured: Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months
Phase II: Duration of Response (DoR) According to RECIST v1.1
The DoR applies only to subjects whose BOR is either CR or PR. The duration is measured from the first documented response (CR or PR, whichever is first recorded) until the first assessment of Progressive Disease (PD).The DoR will be derived from the BOR according to RECIST v1.1 as assessed by the Investigator.
Measured: First documented complete response or partial response, whichever is first recorded until the first assessment of disease progression, assessed up to 24 months
Phase II: Percentage of Subjects With Disease Control
Percentage of subjects with disease control as assessed by best overall response of either CR, PR or Stable Disease (SD) will be reported.
Measured: First documented complete response or partial response, whichever is first recorded until the first assessment of disease progression, assessed up to 24 months
Phase II: Percentage of Subjects Who Received Prophylactic Cranial Irradiation (PCI) and/or Thorax Irradiation After 6 Cycles of Treatment
Measured: After 6 Cycles of treatment, assessed up to 24 months
Phase II: Tumor shrinkage From Baseline in target lesions
Measured: Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months
Phase II: Number of subjects with of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths
An Adverse Event (AE) is defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. A Serious AE (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect.
Measured: From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment
Phase II: Number of Subjects with Abnormal Laboratory Values, Abnormal Vital Signs and Abnormal Electrocardiograms (ECGs)
Measured: From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment
Phase II: Change in Eastern Cooperative Oncology Group performance status (ECOG PS)
Measured: From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment
Phase II: Primary Health-Related Quality of Life (HRQoL) Based on Time to Definitive Deterioration (TUDD) as Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
Measured: Screening; Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months
Phase II: Primary HRQoL based on TUDD Assessed Using EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13)
Measured: Screening; Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months
Phase II: Primary HRQoL based on TUDD Assessed Using European Quality of Life 5- dimensions questionnaire (EQ-5D)
Measured: Screening; Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months
Phase II: Area under the concentration-time curve from 0 to 24 hours (AUC 0-24) for M3814, Cisplatin and Etoposide
Measured: C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Phase II: Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-t ) for M3814, Cisplatin and Etoposide
Measured: C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Phase II: Maximum Observed Plasma Concentration (Cmax) for M3814, Cisplatin and Etoposide
Measured: C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Phase II: Time to Reach Maximum Plasma Concentration (Tmax) for M3814, Cisplatin and Etoposide
Measured: C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Phase II: Apparent Terminal Half-life (t1/2) for M3814
Measured: C1D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose
Phase II: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of M3814
Measured: C1D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose
Phase II: Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of M3814
Measured: C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Phase II: Intravenous (IV) Clearance (CL) of Cisplatin and Etoposide
Measured: Time Frame: C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Phase II: Apparent Volume of Distribution Following Extravascular Administration (Vz/f) of M3814
Measured: C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Phase II: Apparent Volume of Distribution (Vz) of Cisplatin and Etoposide
Measured: C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start25 May 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Why it stopped: Enrollment in the study was prematurely terminated due to recruitment challenges and not due to concerns of safety for the participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by EMD Serono Research & Development Institute, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03116971
- Sponsor's protocol ID
- MS100036-0022
- Status last verified
- Sep 2020
- First submitted
- 28 Mar 2017
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study With an Open Label Phase Ib Part Followed by a Randomized, Placebo-controlled, Double-blind, Phase II Part to Evaluate Efficacy, Safety, Tolerability, and PK of M3814 in Combination With Etoposide and Cisplatin in Subjects With Treatment-naïve Small Cell Lung Cancer (SCLC) Extensive Disease (ED)
- ClinicalTrials.gov ID
- NCT03116971
- Acronym / sponsor ID
- MS100036-0022
- Conditions
- Small Cell Lung Cancer
- Keywords
- M3814, Small Cell Lung Cancer (SCLC), Deoxyribonucleic acid-dependent protein kinase inhibitor, Chemotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment in the study was prematurely terminated due to recruitment challenges and not due to concerns of safety for the participants.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- 25 May 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 17 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
M3814 is an investigational drug under evaluation for treatment of lung cancer. The purpose of the study was to assess the Safety and Efficacy of M3814 in combination with chemotherapy with SCLC ED.
Detailed description
The study was intended to be a phase I/II trial, but the study never moved forward to Phase II due to recruitment challenges.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M3814 PiC with Etoposide and Cisplatin | Experimental | Drug: M3814, Drug: Cisplatin, Drug: EtoposideParticipants received M3814 100 milligram (mg) powder in capsule (PiC) orally once daily in combination with Etoposide 100 mg/m^2 over a 60 minute intravenous infusion on Days 1-3 and Cisplatin 75 milligram per square meter (mg/m^2) over a 60-minute intravenous infusion on Day 1 for 6 cycles with each cycle lasting 3 weeks (21 days) until progressive disease (PD). |
| M3814 (HME Tablet + PiC) with Etoposide and Cisplatin | Experimental | Drug: M3814, Drug: Cisplatin, Drug: EtoposideParticipants received M3814 100 mg hot melt extrusion (HME) tablet orally 5 days prior to Day 1 and M3814 100 mg PiC, orally once daily from Day 1 in combination with Etoposide 100 mg/m^2 over a 60 minute intravenous infusion on Days 1-3 and Cisplatin 75 mg/m^2 over a 60-minute intravenous infusion on Day 1 for 6 cycles with each cycle lasting 3 weeks (21 days) until PD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- To be eligible for the study (Phase Ib and Phase II) the participant must fulfill all of the following criteria:
- Male or female participants at least 18 years of age
- Histological or cytological diagnosis of SCLC
- Extensive disease (ie, disease beyond ipsilateral hemithorax, which may include malignant pleural or pericardial effusion or hematogenous metastases [Tany, Nany, M1a/b; T3-T4, Nany, M0, due to multiple lung nodules or extent of disease that precludes a tolerable radiation field, as judged by the Investigator])
- Participants eligible for first line platinum-based chemotherapy
Key exclusion criteria (12 listed)
- Participants are not eligible for the study if they fulfill any of the following exclusion criteria:
- Prior anticancer therapy for extensive disease (ED) SCLC including experimental agents.
- Concurrent use of other anticancer therapy including any investigational agent within 28 days prior to the first dose of the investigational drug M3814.
- Extensive prior radiotherapy (RT) on more than 30% of bone marrow reserves (by Investigator judgment)
- Prior bone marrow/stem cell transplantation within 5 years before study start (Phase II only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| M3814Also: MSC2490484A, PeposertibParticipants received M3814 PiC or hot melt extrusion (HME) tablet orally once daily in combination with etoposide (intravenously) and cisplatin for 6 cycles with each cycle lasting 3 weeks (21 days). | Drug | M3814 (HME Tablet + PiC) with Etoposide and Cisplatin, M3814 PiC with Etoposide and Cisplatin |
| CisplatinCisplatin 75 milligram per square meter (mg/m^2) was administered over a 60-minute intravenous infusion on Day 1. | Drug | M3814 (HME Tablet + PiC) with Etoposide and Cisplatin, M3814 PiC with Etoposide and Cisplatin |
| EtoposideEtoposide 100 mg/m^2 over a 60 minute IV infusion on Days 1-3 was administered for 6 cycles with each cycle lasting 3 weeks (21 days). | Drug | M3814 (HME Tablet + PiC) with Etoposide and Cisplatin, M3814 PiC with Etoposide and Cisplatin |
Primary outcome
Phase Ib: Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period.
Time frame: up to 21 days
Phase Ib: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of M3814 in Combination With Cisplatin and Etoposide for the Phase II Part of the Study
Time frame: up to 11 months
Phase II: Progression Free Survival (PFS) as Assessed by the Investigator according to RECIST v1.1
Time frame: Time from randomization to first assessment of disease progression or death, whichever is earlier, assessed up to 24 months
PFS time will be evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. The PFS time is defined as the duration from randomization to either first observation of progressive disease (PD) or occurrence of death due to any cause.
47 secondary outcomes
Phase Ib: Number of Subjects with of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths
Time frame: From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment
Phase Ib: Number of Subjects with Abnormal Laboratory Values, Abnormal Vital Signs and Abnormal Electrocardiograms (ECGs)
Time frame: From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment
Phase Ib: Change in Eastern Cooperative Oncology Group performance status (ECOG PS)
Time frame: From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment
Phase Ib: Percentage of Subjects with Objective Response (OR) According to RECIST v1.1
Time frame: Post randomization with period tumor evaluations until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy, assessed up to 11 months
Phase Ib: Duration of Response (DoR) According to RECIST v1.1
Time frame: First documented complete response or partial response, whichever is first recorded until the first assessment of disease progression, assessed up to 11 months
Phase Ib: Percentage of Subjects With Disease Control
Time frame: First documented complete response or partial response, whichever is first recorded until the first assessment of disease progression, assessed up to 11 months
Phase Ib: Progression Free Survival (PFS) According to RECIST v1.1
Time frame: Time from randomization to first assessment of disease progression or death, whichever is earlier, assessed up to 11 months
Phase Ib: Overall Survival (OS)
Time frame: Time from randomization to death due to any cause, assessed up to 11 months
Phase Ib: Area under the concentration-time curve from 0 to 4 hours (AUC 0-4), 0 to 24 hours (AUC 0-24) for M3814, Cisplatin and Etoposide
Time frame: Day (D) -1, Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose, C3D1 Pre-dose and 3.5 hrs post dose
Phase Ib: Area Under the Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUC 0-t ) for M3814, Cisplatin and Etoposide
Time frame: Day (D) -1, Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Phase Ib: Maximum Observed Plasma Concentration (Cmax) for M3814, Cisplatin and Etoposide
Time frame: Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post-dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post-dose, C2D3 Pre-dose
Phase Ib: Time to Reach Maximum Plasma Concentration (Tmax) for M3814, Cisplatin and Etoposide
Time frame: Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post-dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post-dose, C2D3 Pre-dose
Phase Ib: Apparent Terminal Half-life (t1/2) for M3814
Time frame: C1D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hours (hrs) post-dose
Phase Ib: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of M3814
Time frame: C1D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hours (hrs) post-dose
Phase Ib: Total Body Clearance From Plasma Following Extravascular Administration (CL/f) of M3814
Time frame: Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post-dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post-dose, C2D3 Pre-dose
Phase Ib: Intravenous (IV) Clearance (CL) of Cisplatin and Etoposide
Time frame: Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hr post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Phase Ib: Apparent Volume of Distribution Following Extravascular Administration (Vz/f) of M3814
Time frame: Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Phase Ib: Apparent Volume of Distribution (Vz) of Cisplatin and Etoposide
Time frame: Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Phase Ib: Terminal rate constant (λz) for M3814, Cisplatin and Etoposide
Time frame: Day (D) -1, C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Phase Ib: Changes in Cmax for M3814 Between Day -1 and C2D1
Time frame: Day (D) -1, Cycle (C) 2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose
Phase Ib: Changes in AUC for M3814 Between Day -1 and C2D1
Time frame: Day (D) -1, Cycle (C) 2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose
Phase Ib: Changes in AUC for Etoposide From C1D1 to C1D2, C1D3, and C2D1 (for the first 2 dose levels), or From C1D1 to C2D1 (other dose levels)
Time frame: Day (D) -1, Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose
Phase Ib: Changes in Cmax for Etoposide From C1D1 and C2D1
Time frame: Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose
Phase Ib: Changes in AUC for Cisplatin From C1D1 to C1D2, C1D3, and C2D1 (for the first 2 dose levels), or From C1D1 to C2D1 (other dose levels)
Time frame: Day (D) -1, Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose
Phase Ib: Changes in Cmax for Cisplatin From C1D1 and C2D1
Time frame: Cycle (C) 1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5 (excluding D-1), 4, 6 and 8 hours (hrs) post dose
Phase II: Overall Survival (OS)
Time frame: Time from randomization to death due to any cause, assessed up to 24 months
Phase II: Percentage of Subjects with Objective Response (OR) According to RECIST v1.1
Time frame: Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months
Phase II: Duration of Response (DoR) According to RECIST v1.1
Time frame: First documented complete response or partial response, whichever is first recorded until the first assessment of disease progression, assessed up to 24 months
Phase II: Percentage of Subjects With Disease Control
Time frame: First documented complete response or partial response, whichever is first recorded until the first assessment of disease progression, assessed up to 24 months
Phase II: Percentage of Subjects Who Received Prophylactic Cranial Irradiation (PCI) and/or Thorax Irradiation After 6 Cycles of Treatment
Time frame: After 6 Cycles of treatment, assessed up to 24 months
Phase II: Tumor shrinkage From Baseline in target lesions
Time frame: Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months
Phase II: Number of subjects with of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Deaths
Time frame: From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment
Phase II: Number of Subjects with Abnormal Laboratory Values, Abnormal Vital Signs and Abnormal Electrocardiograms (ECGs)
Time frame: From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment
Phase II: Change in Eastern Cooperative Oncology Group performance status (ECOG PS)
Time frame: From the first dose of study drug treatment up to 30 days after the last dose of study drug treatment
Phase II: Primary Health-Related Quality of Life (HRQoL) Based on Time to Definitive Deterioration (TUDD) as Assessed Using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
Time frame: Screening; Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months
Phase II: Primary HRQoL based on TUDD Assessed Using EORTC Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13)
Time frame: Screening; Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months
Phase II: Primary HRQoL based on TUDD Assessed Using European Quality of Life 5- dimensions questionnaire (EQ-5D)
Time frame: Screening; Post randomization every 6 weeks up to Week 54 and then every 12 weeks until disease progression or subject withdrawal of consent, irrespective of treatment discontinuation or initiation of another therapy., assessed up to 24 months
Phase II: Area under the concentration-time curve from 0 to 24 hours (AUC 0-24) for M3814, Cisplatin and Etoposide
Time frame: C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Phase II: Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC 0-t ) for M3814, Cisplatin and Etoposide
Time frame: C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Phase II: Maximum Observed Plasma Concentration (Cmax) for M3814, Cisplatin and Etoposide
Time frame: C1D1, C2D1: Pre-dose, 0.5, 1, 1.5, 2, 3, 3.5, 4, 6 and 8 hrs post dose; C1D2 Pre-dose, C1D3 Pre-dose, C1D8 Pre-dose, C1D15 Pre-dose and 2 hrs post dose, C2D3 Pre-dose
Results and safety
The study was stopped early (reason given: Enrollment in the study was prematurely terminated due to recruitment challenges and not due to concerns of safety for the participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck KGaA, Darmstadt, Germany
80 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing M3814, Cisplatin and Etoposide in people with Small Cell Lung Cancer, run by EMD Serono Research & Development Institute, Inc. at 80 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 80 sites in United States, Germany, Belgium, Italy, Bulgaria and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrollment in the study was prematurely terminated due to recruitment challenges and not due to concerns of safety for the participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib: Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period. (time frame: up to 21 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.