Advanced CancerPhase 1/2NCT02805660
Phase 1/2 Study of Mocetinostat and Durvalumab in Patients With Advanced Solid Tumors and NSCLC
A Phase 1/2 study testing Mocetinostat - 50 mg, Mocetinostat - 70 mg and Mocetinostat - 90 mg in people with Advanced Cancer, run by Mirati Therapeutics Inc. at 15 sites in United States.
Trial summary
Mocetinostat (MGCD0103) is an orally administered HDAC inhibitor. Durvalumab (MEDI4736) is a human monoclonal antibody that is an inhibitor of the Programmed Cell Death Ligand (or PD-L1). Durvalumab is also known as a checkpoint inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- Mocetinostat - 50 mg, Mocetinostat - 70 mg and Mocetinostat - 90 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 15 sitesUnited States
- Study dates
- 1 Jun 2016to 20 Dec 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Phase 1-Diagnosis of advanced or metastatic solid tumor; Phase 2-Diagnosis of NSCLC
- Not amenable to treatment with curative intent
- Adequate bone marrow and organ function
Who cannot join
- Impaired heart function
- Uncontrolled tumor in the brain
- Other active cancer
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611
Mary Crowley Cancer Research Centers
Dallas, Texas, 75230
Texas Oncology - Denton South
Denton, Texas, 76210
NorthShore University Health System
Evanston, Illinois, 60201
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Hackensack University Medical Center
Hackensack, New Jersey, 07601
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Unniversity of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55414
Southern Cancer Center, PC
Mobile, Alabama, 36608
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Woodlands Medical Specialists - Pensacola
Pensacola, Florida, 32503
Texas Oncology-Plano West
Plano, Texas, 75093
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Montefiore Medical Center
The Bronx, New York, 10461
Shenandoah Oncology - Winchester
Winchester, Virginia, 22601
About this study
Official title: A Phase 1/2 Study of HDAC Inhibitor, Mocetinostat, in Combination With PD-L1 Inhibitor, Durvalumab, in Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer
Mocetinostat (MGCD0103) is an orally administered HDAC inhibitor. Durvalumab (MEDI4736) is a human monoclonal antibody that is an inhibitor of the Programmed Cell Death Ligand (or PD-L1). Durvalumab is also known as a checkpoint inhibitor.
This study is evaluating the combination regimen of mocetinostat and durvalumab in participants with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer.
- Conditions
- Advanced Cancer
- Being tested
- Mocetinostat - 50 mg, Mocetinostat - 70 mg, Mocetinostat - 90 mg, Mocetinostat - Recommended Phase 2 Dose (70 mg), Durvalumab - 1500 mg
- Keywords
- MGCD0103, MEDI4736, Mocetinostat, Durvalumab, HDAC Inhibitor, PD-L1 Inhibitor, Phase 1, Phase 2, Metastatic Solid Tumor, Non-small cell lung cancer, immunotherapy, checkpoint inhibitor
- Medical subject headings
- Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mocetinostat - 50 mgDrug
Also called MGCD0103
Participants received mocetinostat three times weekly as an oral capsule.
Mocetinostat - 70 mgDrug
Also called MGCD0103
Participants received mocetinostat three times weekly as an oral capsule.
Mocetinostat - 90 mgDrug
Also called MGCD0103
Participants received mocetinostat three times weekly as an oral capsule.
Mocetinostat - Recommended Phase 2 Dose (70 mg)Drug
Also called MGCD0103
Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
Durvalumab - 1500 mgDrug
Also called MEDI4736
Participants received durvalumab as an intravenous infusion every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Dose Escalation - 50 mg | Experimental | The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase. Receives: Drug: Mocetinostat - 50 mg; Drug: Durvalumab - 1500 mg |
| Phase 1: Dose Escalation - 70 mg | Experimental | The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase. Receives: Drug: Mocetinostat - 70 mg; Drug: Durvalumab - 1500 mg |
| Phase 1: Dose Escalation - 90 mg | Experimental | The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase. Receives: Drug: Mocetinostat - 90 mg; Drug: Durvalumab - 1500 mg |
| Phase 2: Combination Regimen - Cohort 1 | Experimental | Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort. Receives: Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg); Drug: Durvalumab - 1500 mg |
| Phase 2: Combination Regimen - Cohort 2 | Experimental | Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort. Receives: Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg); Drug: Durvalumab - 1500 mg |
| Phase 2: Combination Regimen - Cohort 3 | Experimental | Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort. Receives: Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg); Drug: Durvalumab - 1500 mg |
| Phase 2: Combination Regimen - Cohort 4 | Experimental | Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort. Receives: Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg); Drug: Durvalumab - 1500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) During the First 28-day Cycle of Combination Treatment In Phase 1
Toxicities were graded using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03. Any of the following events considered to be causally related to treatment with mocetinostat in combination with durvalumab that occurred during Phase 1 were considered a DLT:
- Any Grade 4 immune-related adverse event (irAE)
- Grade 3 or greater colitis
- Grade 3 or greater noninfectious pneumonitis
- Grade 2 pneumonitis that did not resolve to ≤ Grade 1 within 3 days of the initiation of maximal supportive care
- Grade 3 irAE (excluding colitis or pneumonitis) that:
- Did not resolve to Grade 2 within 3 days after onset of the event despite optimal medical management including systemic corticosteroids, or
- Did not resolve to Grade ≤1 or Baseline within 14 days
- Liver transaminase elevation >8×upper limit of normal (ULN) or total bilirubin >5×ULN
- Grade 3 or greater non-irAE, except nausea, vomiting, anorexia, dehydration, or diarrhea
Measured: 28 days
Objective Response Rate (ORR)
Objective Response Rate (ORR) was defined as the number of participants documented to have a confirmed Complete Response (CR) or Partial Response (PR). Complete Response was defined as the complete disappearance of all target lesions with the exception of nodal disease. Partial Response was defined at least a 30% decrease in the sum of diameters of target measurable lesions. Responses were determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Participants without response data were counted as non-responders.
Inferential statistical analyses were conducted for Phase 2 only, as efficacy was not part of the Phase 1 objectives.
Measured: Up to approximately 10 months
Secondary outcomes (10)
Number of Participants Experiencing Treatment-Emergent Adverse Events
Measured: Day 1 to 28 days after last dose of study treatment (up to a maximum of 125 weeks in phase 1 and a maximum of 92 weeks in phase 2)
Duration of Response (DR)
DR was defined as the time in days from date of the first documentation of objective response (Complete Response [CR] or Partial Response [PR]) to the first documentation of objective Progressive Disease (PD) or to death due to any cause in the absence of documented PD. DR was only calculated for the subgroup of participants who achieved a Best Overall Response of CR or PR and was presented for responses assessed by Investigator's assessment.
Data is displayed for Phase 2 only, as no participants experienced an objective response (CR or PR) during Phase 1.
Measured: Up to approximately 10 months
Clinical Benefit Rate (CBR)
Clinical benefit rate (CBR) was defined as the number of participants documented to have a confirmed Complete Response (CR), Partial Response (PR), or Stable Disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Participants who were not be able to be assessed for response were counted as non-responders.
Measured: Up to approximately 10 months
Progression-Free Survival (PFS)
Progression-free survival (PFS) was defined as the time from date of first study treatment to first Progressive Disease (PD) or death due to any cause in the absence of documented PD per RECIST v1.1
Measured: Randomization until progressive disease or death due to any cause (up to 42 months)
1-Year Survival Rate
Measured: 1 year
Overall Survival (OS)
OS was defined as the time from first dose of study treatment to the date of death due to any cause.
Measured: From date of first study treatment until death due to any cause (up to 42 months)
Concentration of Mocetinistat in Blood Plasma
Measured: Cycle 1 Day 1 pre-dose, 1, 3, and 7 hours post-dose, Cycle 1 Day 15 pre-dose and 1 hour post-dose, Cycle 2 Day 1 pre-dose and 1 hour post-dose, Cycle 3 Day 1 pre-dose and 1 hour post-dose and Cycle 7 Day 1 pre-dose (each cycle is 28 days)
Concentration of Durvalumab in Blood Plasma
Plasma concentration of Durvalumab was evaluated. All participants received the same Durvalumab dose regardless of Mocetinistat dose group.
Measured: Cycle 1 Day 1 pre-dose + end of infusion, Cycle 1 Day 15 pre-mocetinostat dose, Cycle 2 Day 1 pre-dose, Cycle 3 Day 1 pre-dose, Cycle 4 Day 1 pre-dose + end of infusion, Cycle 7 Day 1 pre-dose + 90 days after participant's last dose (Up to max 133 weeks)
Number of Participants With the Presence of Anti-Drug Antibody (ADA) in the Blood
Measured: Up to approximately 10 months
Number of Participants With Tumor Expression of Programmed Cell Death Ligand 1 (PD-L1) at Baseline
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start1 Jun 2016
- Primary completion14 Dec 2019
- Study completion20 Dec 2019
Why it stopped: The study was discontinued early because the Sponsor de-prioritized development of mocetinostat. The decision to stop was not due to any patient safety issues.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirati Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805660
- Sponsor's protocol ID
- 0103-020
- Status last verified
- Mar 2021
- First submitted
- 10 Jun 2016
- Last updated
- 6 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of HDAC Inhibitor, Mocetinostat, in Combination With PD-L1 Inhibitor, Durvalumab, in Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02805660
- Acronym / sponsor ID
- 0103-020
- Conditions
- Advanced Cancer
- Keywords
- MGCD0103, MEDI4736, Mocetinostat, Durvalumab, HDAC Inhibitor, PD-L1 Inhibitor, Phase 1, Phase 2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was discontinued early because the Sponsor de-prioritized development of mocetinostat. The decision to stop was not due to any patient safety issues.
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Mirati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 14 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Posted 6 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mocetinostat (MGCD0103) is an orally administered HDAC inhibitor. Durvalumab (MEDI4736) is a human monoclonal antibody that is an inhibitor of the Programmed Cell Death Ligand (or PD-L1). Durvalumab is also known as a checkpoint inhibitor.
This study is evaluating the combination regimen of mocetinostat and durvalumab in participants with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Dose Escalation - 50 mg | Experimental | Drug: Mocetinostat - 50 mg, Drug: Durvalumab - 1500 mgThe Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase. |
| Phase 1: Dose Escalation - 70 mg | Experimental | Drug: Mocetinostat - 70 mg, Drug: Durvalumab - 1500 mgThe Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase. |
| Phase 1: Dose Escalation - 90 mg | Experimental | Drug: Mocetinostat - 90 mg, Drug: Durvalumab - 1500 mgThe Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase. |
| Phase 2: Combination Regimen - Cohort 1 | Experimental | Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg), Drug: Durvalumab - 1500 mgParticipants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort. |
| Phase 2: Combination Regimen - Cohort 2 | Experimental | Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg), Drug: Durvalumab - 1500 mgParticipants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort. |
| Phase 2: Combination Regimen - Cohort 3 | Experimental | Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg), Drug: Durvalumab - 1500 mgParticipants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort. |
| Phase 2: Combination Regimen - Cohort 4 | Experimental | Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg), Drug: Durvalumab - 1500 mgParticipants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Phase 1-Diagnosis of advanced or metastatic solid tumor; Phase 2-Diagnosis of NSCLC
- Not amenable to treatment with curative intent
- Adequate bone marrow and organ function
Key exclusion criteria (3 listed)
- Impaired heart function
- Uncontrolled tumor in the brain
- Other active cancer
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 |
|---|---|---|
| Mocetinostat - 50 mgAlso: MGCD0103Participants received mocetinostat three times weekly as an oral capsule. | Drug | Phase 1: Dose Escalation - 50 mg |
| Mocetinostat - 70 mgAlso: MGCD0103Participants received mocetinostat three times weekly as an oral capsule. | Drug | Phase 1: Dose Escalation - 70 mg |
| Mocetinostat - 90 mgAlso: MGCD0103Participants received mocetinostat three times weekly as an oral capsule. | Drug | Phase 1: Dose Escalation - 90 mg |
| Mocetinostat - Recommended Phase 2 Dose (70 mg)Also: MGCD0103Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). | Drug | Phase 2: Combination Regimen - Cohort 1, Phase 2: Combination Regimen - Cohort 2, Phase 2: Combination Regimen - Cohort 3, Phase 2: Combination Regimen - Cohort 4 |
| Durvalumab - 1500 mgAlso: MEDI4736Participants received durvalumab as an intravenous infusion every 4 weeks. | Drug | Phase 1: Dose Escalation - 50 mg, Phase 1: Dose Escalation - 70 mg, Phase 1: Dose Escalation - 90 mg, Phase 2: Combination Regimen - Cohort 1, Phase 2: Combination Regimen - Cohort 2, Phase 2: Combination Regimen - Cohort 3, Phase 2: Combination Regimen - Cohort 4 |
Primary outcome
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) During the First 28-day Cycle of Combination Treatment In Phase 1
Time frame: 28 days
Toxicities were graded using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03. Any of the following events considered to be causally related to treatment with mocetinostat in combination with durvalumab that occurred during Phase 1 were considered a DLT: * Any Grade 4 immune-related adverse event (irAE) * Grade 3 or greater colitis * Grade 3 or greater noninfectious pneumonitis * Grade 2 pneumonitis that did not resolve to ≤ Grade 1 within 3 days of the initiation of maximal supportive care * Grade 3 irAE (excluding colitis or pneumonitis) that: * Did not resolve to Grade 2 within 3 days after onset of the event despite optimal medical management including systemic corticosteroids, or * Did not resolve to Grade ≤1 or Baseline within 14 days * Liver transaminase elevation >8×upper limit of normal (ULN) or total bilirubin >5×ULN * Grade 3 or greater non-irAE, except nausea, vomiting, anorexia, dehydration, or diarrhea
Objective Response Rate (ORR)
Time frame: Up to approximately 10 months
Objective Response Rate (ORR) was defined as the number of participants documented to have a confirmed Complete Response (CR) or Partial Response (PR). Complete Response was defined as the complete disappearance of all target lesions with the exception of nodal disease. Partial Response was defined at least a 30% decrease in the sum of diameters of target measurable lesions. Responses were determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Participants without response data were counted as non-responders. Inferential statistical analyses were conducted for Phase 2 only, as efficacy was not part of the Phase 1 objectives.
10 secondary outcomes
Number of Participants Experiencing Treatment-Emergent Adverse Events
Time frame: Day 1 to 28 days after last dose of study treatment (up to a maximum of 125 weeks in phase 1 and a maximum of 92 weeks in phase 2)
Duration of Response (DR)
Time frame: Up to approximately 10 months
Clinical Benefit Rate (CBR)
Time frame: Up to approximately 10 months
Progression-Free Survival (PFS)
Time frame: Randomization until progressive disease or death due to any cause (up to 42 months)
1-Year Survival Rate
Time frame: 1 year
Overall Survival (OS)
Time frame: From date of first study treatment until death due to any cause (up to 42 months)
Concentration of Mocetinistat in Blood Plasma
Time frame: Cycle 1 Day 1 pre-dose, 1, 3, and 7 hours post-dose, Cycle 1 Day 15 pre-dose and 1 hour post-dose, Cycle 2 Day 1 pre-dose and 1 hour post-dose, Cycle 3 Day 1 pre-dose and 1 hour post-dose and Cycle 7 Day 1 pre-dose (each cycle is 28 days)
Concentration of Durvalumab in Blood Plasma
Time frame: Cycle 1 Day 1 pre-dose + end of infusion, Cycle 1 Day 15 pre-mocetinostat dose, Cycle 2 Day 1 pre-dose, Cycle 3 Day 1 pre-dose, Cycle 4 Day 1 pre-dose + end of infusion, Cycle 7 Day 1 pre-dose + 90 days after participant's last dose (Up to max 133 weeks)
Number of Participants With the Presence of Anti-Drug Antibody (ADA) in the Blood
Time frame: Up to approximately 10 months
Number of Participants With Tumor Expression of Programmed Cell Death Ligand 1 (PD-L1) at Baseline
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mocetinostat - 50 mg, Mocetinostat - 70 mg and Mocetinostat - 90 mg in people with Advanced Cancer, run by Mirati Therapeutics Inc. at 15 sites in United States.
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 3 inclusion and 3 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 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants Who Experience a Dose-Limiting Toxicity (DLT) During the First 28-day Cycle of Combination Treatment In Phase 1 (time frame: 28 days). The study lists 2 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 6 Apr 2021.