Recurrent Glioblastoma MultiformePhase 1NCT01934361
Phase Ib/II Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme
A Phase 1 study testing buparlisib, carboplatin and lomustine in people with Recurrent Glioblastoma Multiforme, run by Novartis Pharmaceuticals at 14 sites in 6 countries.
Trial summary
This is a multi-center, phase Ib/ II study (two parts) with patients that had recurrent glioblastoma multiforme. The first part (phase Ib) was to investigate the maximum tolerated dose/Recommended phase ll dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week carboplatin or buparlisib once… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma Multiforme
- What is being tested?
- buparlisib, carboplatin and lomustine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 14 sitesin 6 countries
- Study dates
- 28 Feb 2014to 7 Jul 2016
- 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
- Patient is an adult ≥ 18 years old at the time of informed consent.
- Patient has histologically confirmed diagnosis of GBM with documented recurrence after first line treatment including radiotherapy and TMZ (SoC), not suitable for curative surgery or re-irradiation.
- Patient has at least one measurable and/or non-measurable lesion as per RANO criteria
- Patient has recovered (to Grade ≤1) from all clinically significant toxicities related to prior antineoplastic therapies.
- Patient has Karnofsky performance status (KPS) ≥70%.
- Patient has adequate organ and bone marrow functions:
Show all 16Show fewer
- Absolute Neutrophils Count (ANC) ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L (in case of transfusion stable for ≥14 days prior to treatment start)
- Hemoglobin ≥ 9.0 g/dL (in case of transfusion stable for ≥14 days prior to treatment start)
- INR ≤ 1,5
- Serum Creatinine ≤ 1.5 x ULN, or Creatinine Clearance > 45mL/min
- Potassium and calcium (corrected for albumin), sodium and magnesium within institutional normal limits
- Serum Bilirubin ≤ ULN, AST and ALT ≤ ULN
- HbA1c ≤ 8%
- Fasting plasma glucose (FPG) ≤ 120 mg/dL or ≤ 6.7 mmol/L
- Patient has tumor tissues available (archival or fresh).
Who cannot join
- Patient has received previous treatment with PI3K inhibitors, lomustine or carboplatin.
- Patient has received previous antineoplastic treatment for recurrent GBM (e.g. VEGF inhibitors, cytotoxic agents).
- Patient has received more than one line of cytotoxic chemotherapy
- Patient has concurrent use of anti-neoplastic agents including investigational therapy
- Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed.
- Patient is currently receiving treatment with drugs known to be moderate or strong inhibitors or inducers of isoenzyme CYP3A. The patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the treatment is initiated. Switching to a different medication prior to randomization is allowed.
- Patient is currently receiving an enzyme-inducing anti-epileptic drug (EIAED). The patient must have discontinued EIAED therapy for at least two weeks prior to starting study drug.
- Other protocol-defined Inclusion/exclusion criteria may apply.
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
United States5 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Northwestern University
Chicago, Illinois, 60611
Highlands Oncology Group
Fayetteville, Arkansas, 72703
MD Anderson Cancer Center/University of Texas
Houston, Texas, 77030
Barrow Neurological Insitute St. Joseph's Hospital
Phoenix, Arizona, 85013
France3 sites
Novartis Investigative Site
Marseille, 13885
Novartis Investigative Site
Paris, 75651
Novartis Investigative Site
Saint-Herblain, 44805
Australia2 sites
Novartis Investigative Site
Heidelberg, Victoria, 3084
Novartis Investigative Site
Parkville, Victoria, 3050
Spain2 sites
Novartis Investigative Site
Barcelona, Catalonia, 08036
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, 08907
About this study
Official title: Phase Ib/II Multicenter Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme
This is a multi-center, phase Ib/ II study (two parts) with patients that had recurrent glioblastoma multiforme. The first part (phase Ib) was to investigate the maximum tolerated dose/Recommended phase ll dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week carboplatin or buparlisib once daily in combination with every-six-week lomustine (CCNU) using a Bayesian model. Once MTD/ RP2D is established in either of the 2 arms, the corresponding phase II portion of the study was to start. Phase II was to assess the treatment effect of buparlisib in combination with carboplatin in terms of Progression Free Survival (PFS) and was to compare the treatment effect of buparlisib with lomustine versus lomustine plus placebo in terms of PFS.
A preliminary assessment for both combinations (buparlisib plus carboplatin or lomustine) demonstrated that there was not enough antitumor activity compared to historical data with single agent carboplatin or lomustine. Based on the overall safety profile, and preliminary anti-tumor activity observed in this study, Novartis decided that no additional patients would be enrolled into this study. As a consequence, the Phase II part of the study was not conducted.
- Conditions
- Recurrent Glioblastoma Multiforme
- Being tested
- buparlisib, carboplatin, lomustine, placebo
- Keywords
- BKM120, Recurrent glioblastoma multiforme, rGBM, buparlisib
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buparlisibDrug
Buparlisib administered orally on a continuous daily schedule. Buparlisib is manufactured as 10mg and 50mg hard gelatin capsules.
carboplatinDrug
Carboplatin intravenous infusion will be administered at a dose of AUC 5 in a 21 day cycle (every 3 weeks).
lomustineDrug
Lomustine will be administered as a single oral dose of 100 mg/m² every 6 weeks in a 42 day cycles.
placeboDrug
Placebo will be administered orally on a continuous QD dosing schedule for cycles of 42 days. Buparlisib matching placebo is manufactured as 10 mg and 50 mg hard gelatin capsules.
| Study group | Role | What they receive |
|---|---|---|
| Lomustine+ buparlisib (Phase Ib) | Experimental | Not described Receives: Drug: buparlisib; Drug: lomustine |
| carboplatin+ buparlisib (Phase Ib) | Experimental | Not described Receives: Drug: buparlisib; Drug: carboplatin |
| lomustine+ buparlisib (Phase II) | Experimental | Not described Receives: Drug: buparlisib; Drug: lomustine |
| lumustine + placebo (Phase II) | Placebo comparator | Not described Receives: Drug: lomustine; Drug: placebo |
| carboplatin+ buparlisib (Phase II) | Experimental | Not described Receives: Drug: buparlisib; Drug: carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Total Dose-limiting Toxicity (DLT) during Dose Escalation part to determine Maximum Tolerated Dose (MTD) [Phase Ib]
Maximum Tolerated Dose (MTD) is defined as the highest BKM120 dosage that does not cause medically unacceptable Dose Limiting Toxicities (DLTs) in more than 35% of the treated patients during the first cycle of treatment. DLT is defined as treatment-related toxicity occurring during the phase Ib cycle 1 and meeting specific protocol-predefined criteria. The information will be integrated in a Bayesian logistic regression model with overdose control to estimate the MTD.
Measured: Cycle 1 (21 days carboplatin combination or 42 days lomustine combination )
12 week Progression Free Survival (PFS) rate (Phase II- Carboplatin combination)
12-week Progression Free Survival (PFS) is defined as the percentage of patients who are progression free 12 weeks after the date of the start of the treatment ("success"). Patients who progressed, died or discontinued within the 12 weeks of observation are counted as "failure".
Measured: 12 weeks
Progression Free Survival (PFS) [phase II lomustine combinations]
Progression Free Survival (PFS) is defined as the time from date of randomization to the date of the event, which is the first radiologically documented disease progression [per local investigator assessment according to Response Assessment in Neuro-Oncology (RANO) criteria] or death due to any cause.
Measured: Randomization until date of the event (expected average 3 months).
Secondary outcomes (11)
Frequency and severity of Adverse Events (AEs) [Phase Ib, Phase II, all treatment arms]
The incidence of Adverse Events (AEs) summarized by system organ class and or preferred term, severity (based on Common Terminology Criteria for Adverse Events (CTCAE) grades version 4), type of AE, relation to study treatment.
Measured: Until 30 days after treatment discontinuation
Overall Response Rate (ORR) as per Response Assessment in Neuro-Oncology (RANO) [Phase Ib , both combinations]
Overall response rate (ORR) is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR), based on the investigator assessment as per Response Assessment in Neuro-Oncology (RANO) criteria.
Measured: Baseline, every 6 weeks from treatment start until disease progression or until start of another antineoplastic treatment or death which ever occurs first up to 1 year
Progression Free Survival (PFS) [Phase Ib- both combinations]
Progression Free Survival (PFS) is defined as time from date of treatment start to the date of the event, which is the first radiologically documented disease progression or death due to any cause per local investigator assessment.
Measured: Time from treatment start to the date of the event (expected average 3 months)
Overall response rate (ORR) [Phae II, carboplatin combination]
Overall response rate (ORR) is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR), based on the investigator assessment as per Response Assessment in Neuro-Oncology (RANO) criteria.
Measured: Baseline, every 6 weeks from treatment start until disease progression or until start of another antineoplastic treatment or death which ever occurs first up to 1 year
Progression Free Survival (PFS) [Phase II, carboplatin combination]
Progression Free Survival (PFS) is defined as time from date of treatment start to the date of the event, which is the first radiologically documented disease progression or death due to any cause per local investigator assessment.
Measured: Time from treatment start to the date of the event (Expected average: 3 months)
24 week Progression Free Survival (PFS) rate (Phase II carboplatin combination)
24 weeks Progression Free Survival (PFS) is defined as the percentage of patients who are progression free 24 weeks after the date of the start of the treatment ("success"). Patients who progressed, died or discontinued within the 24 weeks of observation are counted as "failure".
Measured: 24 weeks
Overall Survival (OS) (Phase II Carboplatin combination)
Overall survival (OS) is defined as the time from the date of randomization for buparlisib + lomustine / placebo + lomustine Phase II, or the time from the first study drug intake for buparlisib + carboplatin Phase II, to the date of death due to any cause.
Measured: 12 months
Overall Response Rate (ORR) (Phase II Lomustine combinations)
Overall response rate (ORR) is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR), based on the investigator assessment as per Response Assessment in Neuro-Oncology (RANO) criteria.
Measured: Baseline, every 6 weeks from treatment start until disease progression or until start of another antineoplastic treatment or death which ever occurs first up to 1 year
12 week Progression Free Survival (PFS) rate (Phase II- lomustine combinations)
12-week Progression Free Survival (PFS) is defined as the percentage of patients who are progression free 12 weeks after the date of the start of the treatment ("success"). Patients who progressed, died or discontinued within the 12 weeks of observation are counted as "failure".
Measured: 12 weeks
24 week Progression Free Survival (PFS) rate (Phase II- lomustine combinations)
24 weeks Progression Free Survival (PFS) is defined as the percentage of patients who are progression free 24 weeks after the date of the start of the treatment ("success"). Patients who progressed, died or discontinued within the 24 weeks of observation are counted as "failure".
Measured: 24 weeks
Overall survival (OS) [Phase II lomustine combinations]
Overall survival (OS) is defined as the time from the date of randomization for buparlisib + lomustine / placebo + lomustine Phase II, or the time from the first study drug intake for buparlisib + carboplatin Phase II, to the date of death due to any cause.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study start28 Feb 2014
- Primary completion7 Jul 2016
- Study completion7 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrent Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934361
- Sponsor's protocol ID
- CBKM120E2102
- Other IDs
- 2013-003129-27
- Status last verified
- Aug 2018
- First submitted
- 20 Aug 2013
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosenthal M, Clement PM, Campone M, Gil-Gil MJ, DeGroot J, Chinot O, Idbaih A, Gan H, Raizer J, Wen PY, Pineda E, Donnet V, Mills D, El-Hashimy M, Mason W. Buparlisib plus carboplatin or lomustine in patients with recurrent glioblastoma: a phase Ib/II, open-label, multicentre, randomised study. ESMO Open. 2020 Jul;5(4):e000672. doi: 10.1136/esmoopen-2020-000672.
PubMed 32665311
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Multicenter Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT01934361
- Acronym / sponsor ID
- CBKM120E2102
- Conditions
- Recurrent Glioblastoma Multiforme
- Keywords
- BKM120, Recurrent glioblastoma multiforme, rGBM, buparlisib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2014 (actual)
- Primary completion
- 7 Jul 2016 (actual)
- Study completion
- 7 Jul 2016 (actual)
- First posted
- 4 Sep 2013 (estimated)
- 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.
This is a multi-center, phase Ib/ II study (two parts) with patients that had recurrent glioblastoma multiforme. The first part (phase Ib) was to investigate the maximum tolerated dose/Recommended phase ll dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week carboplatin or buparlisib once daily in combination with every-six-week lomustine (CCNU) using a Bayesian model. Once MTD/ RP2D is established in either of the 2 arms, the corresponding phase II portion of the study was to start. Phase II was to assess the treatment effect of buparlisib in combination with carboplatin in terms of Progression Free Survival (PFS) and was to compare the treatment effect of buparlisib with lomustine versus lomustine plus placebo in terms of PFS.
A preliminary assessment for both combinations (buparlisib plus carboplatin or lomustine) demonstrated that there was not enough antitumor activity compared to historical data with single agent carboplatin or lomustine. Based on the overall safety profile, and preliminary anti-tumor activity observed in this study, Novartis decided that no additional patients would be enrolled into this study. As a consequence, the Phase II part of the study was not conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Lomustine+ buparlisib (Phase Ib) | Experimental | Drug: buparlisib, Drug: lomustine |
| carboplatin+ buparlisib (Phase Ib) | Experimental | Drug: buparlisib, Drug: carboplatin |
| lomustine+ buparlisib (Phase II) | Experimental | Drug: buparlisib, Drug: lomustine |
| lumustine + placebo (Phase II) | Placebo comparator | Drug: lomustine, Drug: placebo |
| carboplatin+ buparlisib (Phase II) | Experimental | Drug: buparlisib, Drug: carboplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient is an adult ≥ 18 years old at the time of informed consent.
- Patient has histologically confirmed diagnosis of GBM with documented recurrence after first line treatment including radiotherapy and TMZ (SoC), not suitable for curative surgery or re-irradiation.
- Patient has at least one measurable and/or non-measurable lesion as per RANO criteria
- Patient has recovered (to Grade ≤1) from all clinically significant toxicities related to prior antineoplastic therapies.
- Patient has Karnofsky performance status (KPS) ≥70%.
Key exclusion criteria (8 listed)
- Patient has received previous treatment with PI3K inhibitors, lomustine or carboplatin.
- Patient has received previous antineoplastic treatment for recurrent GBM (e.g. VEGF inhibitors, cytotoxic agents).
- Patient has received more than one line of cytotoxic chemotherapy
- Patient has concurrent use of anti-neoplastic agents including investigational therapy
- Patient is currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed.
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 |
|---|---|---|
| buparlisibBuparlisib administered orally on a continuous daily schedule. Buparlisib is manufactured as 10mg and 50mg hard gelatin capsules. | Drug | Lomustine+ buparlisib (Phase Ib), carboplatin+ buparlisib (Phase II), carboplatin+ buparlisib (Phase Ib), lomustine+ buparlisib (Phase II) |
| carboplatinCarboplatin intravenous infusion will be administered at a dose of AUC 5 in a 21 day cycle (every 3 weeks). | Drug | carboplatin+ buparlisib (Phase II), carboplatin+ buparlisib (Phase Ib) |
| lomustineLomustine will be administered as a single oral dose of 100 mg/m² every 6 weeks in a 42 day cycles. | Drug | Lomustine+ buparlisib (Phase Ib), lomustine+ buparlisib (Phase II), lumustine + placebo (Phase II) |
| placeboPlacebo will be administered orally on a continuous QD dosing schedule for cycles of 42 days. Buparlisib matching placebo is manufactured as 10 mg and 50 mg hard gelatin capsules. | Drug | lumustine + placebo (Phase II) |
Primary outcome
Number of Total Dose-limiting Toxicity (DLT) during Dose Escalation part to determine Maximum Tolerated Dose (MTD) [Phase Ib]
Time frame: Cycle 1 (21 days carboplatin combination or 42 days lomustine combination )
Maximum Tolerated Dose (MTD) is defined as the highest BKM120 dosage that does not cause medically unacceptable Dose Limiting Toxicities (DLTs) in more than 35% of the treated patients during the first cycle of treatment. DLT is defined as treatment-related toxicity occurring during the phase Ib cycle 1 and meeting specific protocol-predefined criteria. The information will be integrated in a Bayesian logistic regression model with overdose control to estimate the MTD.
12 week Progression Free Survival (PFS) rate (Phase II- Carboplatin combination)
Time frame: 12 weeks
12-week Progression Free Survival (PFS) is defined as the percentage of patients who are progression free 12 weeks after the date of the start of the treatment ("success"). Patients who progressed, died or discontinued within the 12 weeks of observation are counted as "failure".
Progression Free Survival (PFS) [phase II lomustine combinations]
Time frame: Randomization until date of the event (expected average 3 months).
Progression Free Survival (PFS) is defined as the time from date of randomization to the date of the event, which is the first radiologically documented disease progression [per local investigator assessment according to Response Assessment in Neuro-Oncology (RANO) criteria] or death due to any cause.
11 secondary outcomes
Frequency and severity of Adverse Events (AEs) [Phase Ib, Phase II, all treatment arms]
Time frame: Until 30 days after treatment discontinuation
Overall Response Rate (ORR) as per Response Assessment in Neuro-Oncology (RANO) [Phase Ib , both combinations]
Time frame: Baseline, every 6 weeks from treatment start until disease progression or until start of another antineoplastic treatment or death which ever occurs first up to 1 year
Progression Free Survival (PFS) [Phase Ib- both combinations]
Time frame: Time from treatment start to the date of the event (expected average 3 months)
Overall response rate (ORR) [Phae II, carboplatin combination]
Time frame: Baseline, every 6 weeks from treatment start until disease progression or until start of another antineoplastic treatment or death which ever occurs first up to 1 year
Progression Free Survival (PFS) [Phase II, carboplatin combination]
Time frame: Time from treatment start to the date of the event (Expected average: 3 months)
24 week Progression Free Survival (PFS) rate (Phase II carboplatin combination)
Time frame: 24 weeks
Overall Survival (OS) (Phase II Carboplatin combination)
Time frame: 12 months
Overall Response Rate (ORR) (Phase II Lomustine combinations)
Time frame: Baseline, every 6 weeks from treatment start until disease progression or until start of another antineoplastic treatment or death which ever occurs first up to 1 year
12 week Progression Free Survival (PFS) rate (Phase II- lomustine combinations)
Time frame: 12 weeks
24 week Progression Free Survival (PFS) rate (Phase II- lomustine combinations)
Time frame: 24 weeks
Overall survival (OS) [Phase II lomustine combinations]
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Derived from this study: PubMed 32665311Rosenthal M, Clement PM, Campone M, Gil-Gil MJ, DeGroot J, Chinot O, Idbaih A, Gan H, Raizer J, Wen PY, Pineda E, Donnet V, Mills D, El-Hashimy M, Mason W. Buparlisib plus carboplatin or lomustine in patients with recurrent glioblastoma: a phase Ib/II, open-label, multicentre, randomised study. ESMO Open. 2020 Jul;5(4):e000672. doi: 10.1136/esmoopen-2020-000672.
- Results for CBMK120E2102 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing buparlisib, carboplatin and lomustine in people with Recurrent Glioblastoma Multiforme, run by Novartis Pharmaceuticals at 14 sites in 6 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 16 inclusion and 8 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: finished, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, France, Australia, Spain, Belgium and 1 more country. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Total Dose-limiting Toxicity (DLT) during Dose Escalation part to determine Maximum Tolerated Dose (MTD) [Phase Ib] (time frame: Cycle 1 (21 days carboplatin combination or 42 days lomustine combination )). 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?
On the ClinicalTrials.gov record for NCT01934361, which also lists 1 linked publication.
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 9 Dec 2020.