Trial · NCT02805660
Phase 1/2 Study of Mocetinostat and Durvalumab in Patients With Advanced Solid Tumors and NSCLC
NCT02805660, Phase 1, Phase 2, Terminated, Mirati Therapeutics Inc.; results first posted 2021-04-06
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Phase 1/2 Study of Mocetinostat and Durvalumab in Patients With Advanced Solid Tumors and NSCLC. Trials, record NCT02805660. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02805660
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 1/2 Study of Mocetinostat and Durvalumab in Patients With Advanced Solid Tumors and NSCLC
- NCT number
- NCT02805660
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 83 participants, actual
- Lead sponsor
- Mirati Therapeutics Inc.
- Conditions
- Advanced Cancer
- Interventions
- Mocetinostat - 50 mg, Mocetinostat - 70 mg, Mocetinostat - 90 mg, Mocetinostat - Recommended Phase 2 Dose (70 mg), Durvalumab - 1500 mg
- First posted
- 2016-06-20
- Last updated
- 2021-04-06
- Results first posted
- 2021-04-06
- Limitations and caveats
- 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.
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) During the First 28-day Cycle of Combination Treatment In Phase 1 | 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 |
| Primary | Objective Response Rate (ORR) | 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. |
| Secondary | Number of Participants Experiencing Treatment-Emergent Adverse Events | 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) | |
| Secondary | Duration of Response (DR) | Up to approximately 10 months | 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. |
| Secondary | Clinical Benefit Rate (CBR) | Up to approximately 10 months | 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. |
| Secondary | Progression-Free Survival (PFS) | Randomization until progressive disease or death due to any cause (up to 42 months) | 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 |
| Secondary | 1-Year Survival Rate | 1 year | |
| Secondary | Overall Survival (OS) | From date of first study treatment until death due to any cause (up to 42 months) | OS was defined as the time from first dose of study treatment to the date of death due to any cause. |
| Secondary | Concentration of Mocetinistat in Blood Plasma | 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) | |
| Secondary | Concentration of Durvalumab in Blood Plasma | 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) | Plasma concentration of Durvalumab was evaluated. All participants received the same Durvalumab dose regardless of Mocetinistat dose group. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) During the First 28-day Cycle of Combination Treatment In Phase 1 | 28 days | DLT Evaluable Population - Participant must have either been on study for one full cycle and have received treatment with durvalumab and at least 9 of 12 scheduled mocetinostat doses (75%) in Cycle 1 or have experienced a DLT in Cycle 1. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Objective Response Rate (ORR) | Up to approximately 10 months | Clinical Activity Evaluable Population - The Clinical Activity Evaluable Population was defined as all participants who had at least one on-study disease assessment or discontinued from treatment for progressive disease (PD). | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants Experiencing Treatment-Emergent Adverse Events | 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) | Safety Population - The Safety population was defined as all participants who received at least 1 dose of either mocetinostat or durvalumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DR) | Up to approximately 10 months | Clinical Activity Evaluable Population (Subgroup of Responders) - Duration of response was only calculated for the subgroup of participants achieving a CR or PR. | Days | MEDIAN |
| SECONDARY | Clinical Benefit Rate (CBR) | Up to approximately 10 months | Clinical Activity Evaluable Population - The Clinical Activity Evaluable Population was defined as all participants who had at least one on-study disease assessment or discontinued from treatment for progressive disease (PD). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-Free Survival (PFS) | Randomization until progressive disease or death due to any cause (up to 42 months) | Modified Intent-to-Treat Population (mITT) - The mITT Population was defined as all participants who received treatment with both mocetinostat and durvalumab on this study. | Months | MEDIAN |
| SECONDARY | 1-Year Survival Rate | 1 year | Modified Intent-to-Treat Population (mITT) - The mITT Population was defined as all participants who received treatment with both mocetinostat and durvalumab on this study. | Proportion of participants | NUMBER |
| SECONDARY | Overall Survival (OS) | From date of first study treatment until death due to any cause (up to 42 months) | Modified Intent-to-Treat Population (mITT) - The mITT Population was defined as all participants who received treatment with both mocetinostat and durvalumab on this study. | Months | MEDIAN |
| SECONDARY | Concentration of Mocetinistat in Blood Plasma | 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) | Pharmacokinetic Evaluable Population - The Pharmacokinetic (PK) Evaluable Population was defined as all patients who had PK concentration data collected for mocetinostat or durvalumab. Participants were combined for analysis of mocetinistat concentrations, as prespecified in the analysis shells, based on the actual dose of mocetinistat received in each phase of the study. Pharmacokinetic measures at 3 and 7 hours post dose on Cycle 1 Day 1 were only planned for Phase 1. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Concentration of Durvalumab in Blood Plasma | 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) | Pharmacokinetic Evaluable Population - The Pharmacokinetic (PK) Evaluable Population was defined as all patients who had PK concentration data collected for mocetinostat or durvalumab. Participants were combined for analysis of mocetinistat concentrations, as prespecified in the analysis shells, based on the actual dose of mocetinistat received in each phase of the study. Pharmacokinetic measures at 3 and 7 hours post dose on Cycle 1 Day 1 were only planned for Phase 1. | ng/mL | GEOMETRIC_MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group134
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) During the First 28-day Cycle of Combination Treatment In Phase 1 | Phase 1: Dose Escalation - 50 mg | 0 | Participants | ||
| Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) During the First 28-day Cycle of Combination Treatment In Phase 1 | Phase 1: Dose Escalation - 70 mg | 0 | Participants | ||
| Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) During the First 28-day Cycle of Combination Treatment In Phase 1 | Phase 1: Dose Escalation - 90 mg | 0 | Participants | ||
| Objective Response Rate (ORR) | Phase 1: Dose Escalation - 50 mg | 0 | 95% Confidence Interval 0.0 to 52.2 | Percentage of participants | |
| Objective Response Rate (ORR) | Phase 1: Dose Escalation - 70 mg | 0 | 95% Confidence Interval 0.0 to 60.2 | Percentage of participants | |
| Objective Response Rate (ORR) | Phase 1: Dose Escalation - 90 mg | 0 | 95% Confidence Interval 0.0 to 33.6 | Percentage of participants | |
| Objective Response Rate (ORR) | Phase 2: Combination Regimen - Cohort 1 | 6.7 | 95% Confidence Interval 0.2 to 31.9 | Percentage of participants | |
| Objective Response Rate (ORR) | Phase 2: Combination Regimen - Cohort 2 | 0 | 95% Confidence Interval 0.0 to 70.8 | Percentage of participants | |
| Objective Response Rate (ORR) | Phase 2: Combination Regimen - Cohort 3 | 9.5 | 95% Confidence Interval 1.2 to 30.4 | Percentage of participants | |
| Objective Response Rate (ORR) | Phase 2: Combination Regimen - Cohort 4 | 23.1 | 95% Confidence Interval 5.0 to 53.8 | Percentage of participants |
1 to 10 of 134Source ClinicalTrials.gov
See all 134 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1: Dose Escalation - 50 mg | 5 | |
| Overall Study | STARTED | Phase 1: Dose Escalation - 70 mg | 4 | |
| Overall Study | STARTED | Phase 1: Dose Escalation - 90 mg | 11 | |
| Overall Study | STARTED | Phase 2: Combination Regimen - Cohort 1 | 18 | |
| Overall Study | STARTED | Phase 2: Combination Regimen - Cohort 2 | 3 | |
| Overall Study | STARTED | Phase 2: Combination Regimen - Cohort 3 | 23 | |
| Overall Study | STARTED | Phase 2: Combination Regimen - Cohort 4 | 19 | |
| Overall Study | COMPLETED | Phase 1: Dose Escalation - 50 mg | 0 | |
| Overall Study | COMPLETED | Phase 1: Dose Escalation - 70 mg | 0 | |
| Overall Study | COMPLETED | Phase 1: Dose Escalation - 90 mg | 0 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events1,897
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: Dose Escalation - 50 mg | 0 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: Dose Escalation - 70 mg | 1 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1: Dose Escalation - 90 mg | 3 | 11 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Combination Regimen - Cohort 1 | 3 | 18 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Combination Regimen - Cohort 2 | 1 | 3 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Combination Regimen - Cohort 3 | 1 | 23 | |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2: Combination Regimen - Cohort 4 | 3 | 19 | |
| other | Neutropenia | Blood and lymphatic system disorders | Phase 1: Dose Escalation - 50 mg | 2 | 5 | |
| other | Neutropenia | Blood and lymphatic system disorders | Phase 1: Dose Escalation - 70 mg | 0 | 4 | |
| other | Neutropenia | Blood and lymphatic system disorders | Phase 1: Dose Escalation - 90 mg | 3 | 11 |
1 to 10 of 1,897Source ClinicalTrials.gov
See all 1,897 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: Dose Escalation - 50 mg | 5 | 5 |
| Total, all-cause mortality | Phase 1: Dose Escalation - 70 mg | 2 | 4 |
| Total, all-cause mortality | Phase 1: Dose Escalation - 90 mg | 9 | 11 |
| Total, all-cause mortality | Phase 2: Combination Regimen - Cohort 1 | 5 | 18 |
| Total, all-cause mortality | Phase 2: Combination Regimen - Cohort 2 | 0 | 3 |
| Total, all-cause mortality | Phase 2: Combination Regimen - Cohort 3 | 14 | 23 |
| Total, all-cause mortality | Phase 2: Combination Regimen - Cohort 4 | 12 | 19 |
| Total, other adverse events | Phase 1: Dose Escalation - 50 mg | 5 | 5 |
| Total, other adverse events | Phase 1: Dose Escalation - 70 mg | 4 | 4 |
| Total, other adverse events | Phase 1: Dose Escalation - 90 mg | 10 | 11 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02805660
GET https://conductscience.org/api/trials/v1/NCT02805660/results?page=2