Solid TumorsPhase 1NCT01988896
Study of Atezolizumab in Combination With Cobimetinib in Participants With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing Atezolizumab and Cobimetinib in people with Solid Tumors, run by Hoffmann-La Roche at 21 sites in 6 countries.
Trial summary
This is a Phase Ib, open-label, multicenter study designed to assess the safety, tolerability, and pharmacokinetics of coadministration of intravenous (IV) dosing of atezolizumab (an engineered anti-programmed death-ligand 1 [anti-PD-L1] antibody) and oral dosing of cobimetinib in participants with metastatic or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Atezolizumab and Cobimetinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 21 sitesin 6 countries
- Study dates
- 27 Dec 2013to 4 Nov 2019
- 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
- Solid tumor that is metastatic, locally advanced or recurrent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than or equal to (>/=) 12 weeks
- Measurable disease, as defined by RECIST v 1.1
- Adequate hematologic and end organ function
- Use of highly effective contraception
Show all 11Show fewer
- Histological tumor tissue specimen
- Participants enrolling in the indication-specific expansion cohorts in Stage 2 must consent to tumor biopsies and must have one of the following types of cancer:
- Metatastic colorectal cancer
- Non-small cell lung cancer
- Melanoma
Who cannot join
- Cancer-Specific Exclusion Criteria:
- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
- Known active or untreated central nervous system (CNS) metastases
- Leptomeningeal disease
- Uncontrolled tumor-related pain or uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent (once monthly or more frequently) drainage procedures
Show all 28Show fewer
- Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
- General Medical Exclusion Criteria:
- Pregnant and lactating women
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cell or any component of the atezolizumab formulation
- History of autoimmune disease
- Participants with prior allogeneic stem cell or solid organ transplantation
- Positive test for human immunodeficiency virus (HIV)
- Participants with active hepatitis B, hepatitis C, or tuberculosis
- Severe infections within 4 weeks prior to Cycle 1 Day 1
- Signs or symptoms of infection within 2 weeks prior to Cycle 1 Day 1
- Received therapeutic oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
- Significant cardiovascular disease
- Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1 Day 1 or anticipation of need for a major surgical procedure during the course of the study
- Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1
- History of prior significant toxicity from another mitogen-activated protein kinase (MEK) pathway inhibitor requiring discontinuation of treatment
- Allergy or hypersensitivity to components of the cobimetinib formulations
- History of congenital long QT syndrome or corrected QT interval (QTc) greater than (>) 450 milliseconds at screening
- Left ventricular ejection fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%, whichever is lower, as determined by echocardiogram or Multi Gated Acquisition Scan (MUGA) scan
- History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, central serous chorioretinopathy (CSCR), retinal vein occlusion (RVO), or neovascular macular degeneration
- History of malabsorption syndrome or other condition that would interfere with enteral absorption
- Prior treatment with clusters of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, systemic immunostimulatory agents, or systemic immunosuppressive medications
Trial locations and contacts
21 sites in 6 countries.
21 sites in 6 countries
United States11 sites
Texas Oncology, P.A.
Arlington, Texas, 76012
Massachusets General Hospital Clinical Trial Network and Institute
Boston, Massachusetts, 02114
Beth Israel Deaconess Med Ctr; Neurology/MS Center
Boston, Massachusetts, 02215
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
Rocky Mountain Cancer Center - Denver
Denver, Colorado, 80220
SCRI-Tennessee Oncology
Nashville, Tennessee, 37203
Yale University School Of Medicine
New Haven, Connecticut, 06510
Sloan Kettering Cancer Center; Pediatric Hematology/Oncology
New York, New York, 10065
Stanford University Medical Center
Palo Alto, California, 94304
Compass Oncology
Portland, Oregon, 97225
University of Washington Seattle Cancer Care Alliance
Seattle, Washington, 98195
Canada3 sites
CHUM Hôpital Notre-Dame
Montreal, Quebec, H2L 4M1
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Princess Margaret Hospital; Department of Med Oncology
Toronto, Ontario, M5G 2M9
Australia2 sites
Peter MacCallum Cancer Centre-East Melbourne
Melbourne, Victoria, 3000
Royal Melbourne Hospital
Parkville, Victoria, 3050
Germany2 sites
Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden
Dresden, 01307
Universitaetsklinikum Freiburg
Freiburg im Breisgau, 79106
South Korea2 sites
Seoul National University Hospital
Seoul, 03080
Asan Medical Center - Oncology
Seoul, 05505
Singapore1 site
National University Hospital; Cancer Center
Singapore, 119074
About this study
Official title: A Phase Ib Study of the Safety and Pharmacology of Atezolizumab Administered With Cobimetinib in Patients With Locally Advanced or Metastatic Solid Tumors
This is a Phase Ib, open-label, multicenter study designed to assess the safety, tolerability, and pharmacokinetics of coadministration of intravenous (IV) dosing of atezolizumab (an engineered anti-programmed death-ligand 1 [anti-PD-L1] antibody) and oral dosing of cobimetinib in participants with metastatic or locally advanced cancer for which no standard therapy exists.
- Conditions
- Solid Tumors
- Being tested
- Atezolizumab, Cobimetinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtezolizumabDrug
Also called MPDL3280
Atezolizumab will be administered at a fixed dose as specified via IV infusion.
CobimetinibDrug
Also called GDC-0973
Cobimetinib will be administered orally at an escalating dose during Stage 1 and at RP2D during Stage 2.
| Study group | Role | What they receive |
|---|---|---|
| Dose-Escalation: Cobimetinib, Atezolizumab | Experimental | Participants will receive single dose of 800 milligrams (mg) of atezolizumab IV infusion on Day 1, 15 and 29 of Cycle 1 (cycle length=42 days [14-day run-in period + 28-day concomitant dosing period]), thereafter with atezolizumab IV dosing every 2 weeks (q2w) in all subsequent treatment cycles (28 days each). Combination with cobimetinib will begin on Cycle 1 Day 15 and will be given at increasing dose levels during Stage 1. During Stage 1, cobimetinib will be administered once daily (QD) orally for 21 consecutive days out of 28 days (21/7 dosing schedule) at a starting dose of 20 mg with escalation of 20 mg until the maximum tolerated dose (MTD; not more than 60 mg) for the two-drug combination. Receives: Drug: Atezolizumab; Drug: Cobimetinib |
| Dose-Expansion: Cobimetinib, Atezolizumab | Experimental | Participants will receive single dose of 800 mg of atezolizumab IV infusion q2w in all subsequent treatment cycles (28 days each). Participants will receive cobimetinib at the selected recommended RP2D on Days 1-14 of each 28-day cycle during Stage 2. Receives: Drug: Atezolizumab; Drug: Cobimetinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Percentage of Participants With Dose-Limiting Toxicities (DLTs)
Measured: Day 15 to Day 42 of Cycle 1 (cycle length=42 days) of dose-escalation phase
Phase I: Maximum Tolerated Dose of Cobimetinib
Measured: Day 15 to Day 42 of Cycle 1 (cycle length=42 days) of dose-escalation phase
Phase I: Recommended Phase II Dose of Cobimetinib when Combined with Atezolizumab
Measured: Day 15 to Day 42 of Cycle 1 (cycle length=42 days) of dose-escalation phase
Secondary outcomes (12)
Percentage of Participants With Anti-Therapeutic Antibody (ATA) Response to Azetolizumab
Measured: Pre-infusion (Hour 0) on Day 1 of Cycles 1, 2, 3, 4, 8 (cycle length=42 days for Cycle 1; 28 days for subsequent cycles) and at treatment completion visit (up to approximately 3.5 years)
Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs)
Measured: Baseline up to approximately 3.5 years
Serum Maximum Concentration (Cmax) of Atezolizumab
Measured: Pre-infusion (Hour 0) on Day 1 of Cycles 2, 3, 4, 8 (cycle length=28 days) and at treatment completion visit (up to approximately 3.5 years); 30 minutes post-infusion (duration=60 minutes) on Cycle 1 Day 1 (cycle length=42 days)
Serum Minimum Concentration (Cmin) of Atezolizumab
Measured: Pre-infusion (Hour 0) on Day 1 of Cycles 2, 3, 4, 8 (cycle length=28 days) and at treatment completion visit (up to approximately 3.5 years)
Plasma Cmax of Cobimetinib
Measured: Pre-dose (Hour 0) and Hours 2, 4, 6 post-dose on Day 29 of Cycle 1 (cycle length=42 days) and Day 15 of Cycle 2 (cycle length=28 days)
Plasma Cmin of Cobimetinib
Measured: Pre-dose (Hour 0) on Day 29 of Cycle 1 (cycle length=42 days) and Day 15 of Cycle 2 (cycle length=28 days)
Area Under the Concentration-Time Curve (AUC) of Cobimetinib
Measured: Pre-dose (Hour 0) and Hours 2, 4, 6 post-dose on Day 29 of Cycle 1 (cycle length=42 days) and Day 15 of Cycle 2 (cycle length=28 days)
Percentage of Participants With Best Overall Response, as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Baseline up to 3.5 years (assessed at Baseline then every 8 weeks for the first 48 weeks following Day 1 of Cycle 1 [cycle length=42 days]; thereafter every 12 weeks until progressive disease [PD] or death due to any cause, whichever occurs first [up to approximately 3.5 years])
Measured: Baseline up to 3.5 years (detailed time frame is provided in the description)
Percentage of Participants With Objective Response (OR; Confirmed Complete Response or Partial Response) as Assessed by Investigator Using RECIST v1.1
Measured: Baseline up to 3.5 years (assessed at Baseline then every 8 weeks for the first 48 weeks following Day 1 Cycle 1 [cycle length=42 days]; thereafter every 12 weeks until PD or death due to any cause, whichever occurs first [up to approximately 3.5 years])
Duration of OR, as Determined by Investigator Using RECIST v1.1
Measured: Baseline up to 3.5 years (assessed at Baseline then every 8 weeks for the first 48 weeks following Day 1 Cycle 1 [cycle length=42 days]; thereafter every 12 weeks until PD or death due to any cause, whichever occurs first [up to approximately 3.5 years])
Progression-Free Survival (PFS), as Determined by Investigator Using RECIST v1.1
Measured: Baseline up to 3.5 years (assessed at Baseline then every 8 weeks for the first 48 weeks following Day 1 Cycle 1 [cycle length=42 days]; thereafter every 12 weeks until PD or death due to any cause, whichever occurs first [up to approximately 3.5 years])
Overall Survival (OS)
Measured: Baseline up to death due to any cause (up to approximately 3.5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2013 (estimated)
- Study start27 Dec 2013
- Primary completion4 Nov 2019
- Study completion4 Nov 2019
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 Solid TumorsStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01988896
- Sponsor's protocol ID
- GP28363
- Other IDs
- 2013-003329-27
- Status last verified
- Dec 2019
- First submitted
- 14 Nov 2013
- Last updated
- 17 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hellmann MD, Kim TW, Lee CB, Goh BC, Miller WH Jr, Oh DY, Jamal R, Chee CE, Chow LQM, Gainor JF, Desai J, Solomon BJ, Das Thakur M, Pitcher B, Foster P, Hernandez G, Wongchenko MJ, Cha E, Bang YJ, Siu LL, Bendell J. Phase Ib study of atezolizumab combined with cobimetinib in patients with solid tumors. Ann Oncol. 2019 Jul 1;30(7):1134-1142. doi: 10.1093/annonc/mdz113.
PubMed 30918950
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study of the Safety and Pharmacology of Atezolizumab Administered With Cobimetinib in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT01988896
- Acronym / sponsor ID
- GP28363
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2013 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 20 Nov 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 Phase Ib, open-label, multicenter study designed to assess the safety, tolerability, and pharmacokinetics of coadministration of intravenous (IV) dosing of atezolizumab (an engineered anti-programmed death-ligand 1 [anti-PD-L1] antibody) and oral dosing of cobimetinib in participants with metastatic or locally advanced cancer for which no standard therapy exists.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose-Escalation: Cobimetinib, Atezolizumab | Experimental | Drug: Atezolizumab, Drug: CobimetinibParticipants will receive single dose of 800 milligrams (mg) of atezolizumab IV infusion on Day 1, 15 and 29 of Cycle 1 (cycle length=42 days [14-day run-in period + 28-day concomitant dosing period]), thereafter with atezolizumab IV dosing every 2 weeks (q2w) in all subsequent treatment cycles (28 days each). Combination with cobimetinib will begin on Cycle 1 Day 15 and will be given at increasing dose levels during Stage 1. During Stage 1, cobimetinib will be administered once daily (QD) orally for 21 consecutive days out of 28 days (21/7 dosing schedule) at a starting dose of 20 mg with escalation of 20 mg until the maximum tolerated dose (MTD; not more than 60 mg) for the two-drug combination. |
| Dose-Expansion: Cobimetinib, Atezolizumab | Experimental | Drug: Atezolizumab, Drug: CobimetinibParticipants will receive single dose of 800 mg of atezolizumab IV infusion q2w in all subsequent treatment cycles (28 days each). Participants will receive cobimetinib at the selected recommended RP2D on Days 1-14 of each 28-day cycle during Stage 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Solid tumor that is metastatic, locally advanced or recurrent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than or equal to (>/=) 12 weeks
- Measurable disease, as defined by RECIST v 1.1
- Adequate hematologic and end organ function
Key exclusion criteria (28 listed)
- Any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment
- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
- Known active or untreated central nervous system (CNS) metastases
- Leptomeningeal disease
- Uncontrolled tumor-related pain or uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent (once monthly or more frequently) drainage procedures
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 |
|---|---|---|
| AtezolizumabAlso: MPDL3280Atezolizumab will be administered at a fixed dose as specified via IV infusion. | Drug | Dose-Escalation: Cobimetinib, Atezolizumab, Dose-Expansion: Cobimetinib, Atezolizumab |
| CobimetinibAlso: GDC-0973Cobimetinib will be administered orally at an escalating dose during Stage 1 and at RP2D during Stage 2. | Drug | Dose-Escalation: Cobimetinib, Atezolizumab, Dose-Expansion: Cobimetinib, Atezolizumab |
Primary outcome
Phase I: Percentage of Participants With Dose-Limiting Toxicities (DLTs)
Time frame: Day 15 to Day 42 of Cycle 1 (cycle length=42 days) of dose-escalation phase
Phase I: Maximum Tolerated Dose of Cobimetinib
Time frame: Day 15 to Day 42 of Cycle 1 (cycle length=42 days) of dose-escalation phase
Phase I: Recommended Phase II Dose of Cobimetinib when Combined with Atezolizumab
Time frame: Day 15 to Day 42 of Cycle 1 (cycle length=42 days) of dose-escalation phase
12 secondary outcomes
Percentage of Participants With Anti-Therapeutic Antibody (ATA) Response to Azetolizumab
Time frame: Pre-infusion (Hour 0) on Day 1 of Cycles 1, 2, 3, 4, 8 (cycle length=42 days for Cycle 1; 28 days for subsequent cycles) and at treatment completion visit (up to approximately 3.5 years)
Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs)
Time frame: Baseline up to approximately 3.5 years
Serum Maximum Concentration (Cmax) of Atezolizumab
Time frame: Pre-infusion (Hour 0) on Day 1 of Cycles 2, 3, 4, 8 (cycle length=28 days) and at treatment completion visit (up to approximately 3.5 years); 30 minutes post-infusion (duration=60 minutes) on Cycle 1 Day 1 (cycle length=42 days)
Serum Minimum Concentration (Cmin) of Atezolizumab
Time frame: Pre-infusion (Hour 0) on Day 1 of Cycles 2, 3, 4, 8 (cycle length=28 days) and at treatment completion visit (up to approximately 3.5 years)
Plasma Cmax of Cobimetinib
Time frame: Pre-dose (Hour 0) and Hours 2, 4, 6 post-dose on Day 29 of Cycle 1 (cycle length=42 days) and Day 15 of Cycle 2 (cycle length=28 days)
Plasma Cmin of Cobimetinib
Time frame: Pre-dose (Hour 0) on Day 29 of Cycle 1 (cycle length=42 days) and Day 15 of Cycle 2 (cycle length=28 days)
Area Under the Concentration-Time Curve (AUC) of Cobimetinib
Time frame: Pre-dose (Hour 0) and Hours 2, 4, 6 post-dose on Day 29 of Cycle 1 (cycle length=42 days) and Day 15 of Cycle 2 (cycle length=28 days)
Percentage of Participants With Best Overall Response, as Determined by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: Baseline up to 3.5 years (detailed time frame is provided in the description)
Percentage of Participants With Objective Response (OR; Confirmed Complete Response or Partial Response) as Assessed by Investigator Using RECIST v1.1
Time frame: Baseline up to 3.5 years (assessed at Baseline then every 8 weeks for the first 48 weeks following Day 1 Cycle 1 [cycle length=42 days]; thereafter every 12 weeks until PD or death due to any cause, whichever occurs first [up to approximately 3.5 years])
Duration of OR, as Determined by Investigator Using RECIST v1.1
Time frame: Baseline up to 3.5 years (assessed at Baseline then every 8 weeks for the first 48 weeks following Day 1 Cycle 1 [cycle length=42 days]; thereafter every 12 weeks until PD or death due to any cause, whichever occurs first [up to approximately 3.5 years])
Progression-Free Survival (PFS), as Determined by Investigator Using RECIST v1.1
Time frame: Baseline up to 3.5 years (assessed at Baseline then every 8 weeks for the first 48 weeks following Day 1 Cycle 1 [cycle length=42 days]; thereafter every 12 weeks until PD or death due to any cause, whichever occurs first [up to approximately 3.5 years])
Overall Survival (OS)
Time frame: Baseline up to death due to any cause (up to approximately 3.5 years)
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 17 Dec 2019.
- Derived from this study: PubMed 30918950Hellmann MD, Kim TW, Lee CB, Goh BC, Miller WH Jr, Oh DY, Jamal R, Chee CE, Chow LQM, Gainor JF, Desai J, Solomon BJ, Das Thakur M, Pitcher B, Foster P, Hernandez G, Wongchenko MJ, Cha E, Bang YJ, Siu LL, Bendell J. Phase Ib study of atezolizumab combined with cobimetinib in patients with solid tumors. Ann Oncol. 2019 Jul 1;30(7):1134-1142. doi: 10.1093/annonc/mdz113.
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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.
Clinical Trials study director
Hoffmann-La Roche
21 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 Atezolizumab and Cobimetinib in people with Solid Tumors, run by Hoffmann-La Roche at 21 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 11 inclusion and 28 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 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Canada, Australia, Germany, South Korea 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. 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?
Phase I: Percentage of Participants With Dose-Limiting Toxicities (DLTs) (time frame: Day 15 to Day 42 of Cycle 1 (cycle length=42 days) of dose-escalation phase). 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 NCT01988896, 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 17 Dec 2019.