Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Phase 2: Combination Regimen - Cohort 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mocetinostat - 50 mg | Drug | Participants received mocetinostat three times weekly as an oral capsule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 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. | Up to approximately 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Cancer Center, PC | Mobile | Alabama | 36608 | United States | ||
| David Geffen School of Medicine at UCLA |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1: Dose Escalation - 50 mg | The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase. Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 10, 2017 | Dec 11, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
|
| 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. |
|
| 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. |
|
| Mocetinostat - 70 mg | Drug | Participants received mocetinostat three times weekly as an oral capsule. |
|
|
| Mocetinostat - 90 mg | Drug | Participants received mocetinostat three times weekly as an oral capsule. |
|
|
| Mocetinostat - Recommended Phase 2 Dose (70 mg) | Drug | Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
|
|
| Durvalumab - 1500 mg | Drug | Participants received durvalumab as an intravenous infusion every 4 weeks. |
|
|
| 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. | 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 | Randomization until progressive disease or death due to any cause (up to 42 months) |
| 1-Year Survival Rate | 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. | From date of first study treatment until death due to any cause (up to 42 months) |
| 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) |
| Concentration of Durvalumab in Blood Plasma | Plasma concentration of Durvalumab was evaluated. All participants received the same Durvalumab dose regardless of Mocetinistat dose group. | 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 | Up to approximately 10 months |
| Number of Participants With Tumor Expression of Programmed Cell Death Ligand 1 (PD-L1) at Baseline | Baseline |
| Los Angeles |
| California |
| 90095 |
| United States |
| Woodlands Medical Specialists - Pensacola | Pensacola | Florida | 32503 | United States |
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Chicago | Illinois | 60611 | United States |
| NorthShore University Health System | Evanston | Illinois | 60201 | United States |
| Unniversity of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | 55414 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Mary Crowley Cancer Research Centers | Dallas | Texas | 75230 | United States |
| Texas Oncology - Denton South | Denton | Texas | 76210 | United States |
| Texas Oncology-Plano West | Plano | Texas | 75093 | United States |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | United States |
| Shenandoah Oncology - Winchester | Winchester | Virginia | 22601 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| FG001 | Phase 1: Dose Escalation - 70 mg | The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase. Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. |
| FG002 | Phase 1: Dose Escalation - 90 mg | The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase. Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. |
| FG003 | Phase 2: Combination Regimen - Cohort 1 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70mg). |
| FG004 | Phase 2: Combination Regimen - Cohort 2 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| FG005 | Phase 2: Combination Regimen - Cohort 3 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| FG006 | Phase 2: Combination Regimen - Cohort 4 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1: Dose Escalation - 50 mg | The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase. Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. |
| BG001 | Phase 1: Dose Escalation - 70 mg | The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase. Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. |
| BG002 | Phase 1: Dose Escalation - 90 mg | The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase. Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. |
| BG003 | Phase 2: Combination Regimen - Cohort 1 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| BG004 | Phase 2: Combination Regimen - Cohort 2 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| BG005 | Phase 2: Combination Regimen - Cohort 3 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| BG006 | Phase 2: Combination Regimen - Cohort 4 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Smoking History | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| 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. | Posted | Count of Participants | Participants | 28 days |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | 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. | 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). | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to approximately 10 months |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing Treatment-Emergent Adverse Events | Safety Population - The Safety population was defined as all participants who received at least 1 dose of either mocetinostat or durvalumab. | Posted | Count of Participants | Participants | 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) | 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. | Clinical Activity Evaluable Population (Subgroup of Responders) - Duration of response was only calculated for the subgroup of participants achieving a CR or PR. | Posted | Median | 95% Confidence Interval | Days | Up to approximately 10 months |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | 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). | Posted | Count of Participants | Participants | Up to approximately 10 months |
| ||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Posted | Median | 95% Confidence Interval | Months | Randomization until progressive disease or death due to any cause (up to 42 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | 1-Year Survival Rate | 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. | Posted | Number | 95% Confidence Interval | Proportion of participants | 1 year |
| ||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS was defined as the time from first dose of study treatment to the date of death due to any cause. | 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. | Posted | Median | 95% Confidence Interval | Months | From date of first study treatment until death due to any cause (up to 42 months) |
| |||||||||||||||||||||||||||||||||
| Secondary | Concentration of Mocetinistat in Blood Plasma | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 | Plasma concentration of Durvalumab was evaluated. All participants received the same Durvalumab dose regardless of Mocetinistat dose group. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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) |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With the Presence of Anti-Drug Antibody (ADA) in the Blood | ADA Evaluable Population - The ADA Evaluable Population was defined as all patients who received at least 1 dose of either durvalumab or mocetinostat for whom ADA results were available. | Posted | Count of Participants | Participants | Up to approximately 10 months |
| |||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Tumor Expression of Programmed Cell Death Ligand 1 (PD-L1) at Baseline | 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. | Posted | Count of Participants | Participants | Baseline |
|
Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1: Dose Escalation - 50 mg | The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this phase. Mocetinostat: Participants received mocetinostat three times weekly as an oral capsule. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. | 5 | 5 | 4 | 5 | 5 | 5 |
| EG001 | Phase 1: Dose Escalation - 70 mg | The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this phase. Mocetinostat: Participants received mocetinostat three times weekly as an oral capsule. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. | 2 | 4 | 1 | 4 | 4 | 4 |
| EG002 | Phase 1: Dose Escalation - 90 mg | The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this phase. Mocetinostat: Participants received mocetinostat three times weekly as an oral capsule. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. | 9 | 11 | 4 | 11 | 10 | 11 |
| EG003 | Phase 2: Combination Regimen - Cohort 1 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). | 5 | 18 | 6 | 18 | 18 | 18 |
| EG004 | Phase 2: Combination Regimen - Cohort 2 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). | 0 | 3 | 2 | 3 | 3 | 3 |
| EG005 | Phase 2: Combination Regimen - Cohort 3 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). | 14 | 23 | 5 | 23 | 23 | 23 |
| EG006 | Phase 2: Combination Regimen - Cohort 4 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). | 12 | 19 | 11 | 19 | 18 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cardiac tamponade | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gastroenteritis adenovirus | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Bronchostenosis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hyperacusis | Ear and labyrinth disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Episcleritis | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Anorectal disorder | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gastrointestinal wall thickening | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Oesophageal dilatation | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Early satiety | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Catheter site discharge | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Facial pain | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Local swelling | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nodule | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Infected cyst | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nasal herpes | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Medication error | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Stoma site irritation | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Ejection fraction decreased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase decreased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Blood urine present | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Appetite disorder | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Muscle contractions involuntary | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA (19.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Umbilical erythema | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Skin depigmentation | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Subclavian artery stenosis | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
|
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.
PI can not disclose, discuss, or publish study results until final manuscript has been published.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tavette Neskorik, Senior Director, Clinical Science | Mirati Therapeutics | 858-332-3552 | neskorikt@mirati.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 30, 2017 | Jan 8, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C523184 | mocetinostat |
| C000613593 | durvalumab |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Current Smoker |
|
| Former Smoker |
|
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
| OG002 | Phase 1: Dose Escalation - 90 mg | The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase. Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. |
| OG003 | Phase 2: Combination Regimen - Cohort 1 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG004 | Phase 2: Combination Regimen - Cohort 2 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG005 | Phase 2: Combination Regimen - Cohort 3 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG006 | Phase 2: Combination Regimen - Cohort 4 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
|
|
|
| OG003 | Phase 2: Combination Regimen - Cohort 1 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG004 | Phase 2: Combination Regimen - Cohort 2 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG005 | Phase 2: Combination Regimen - Cohort 3 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG006 | Phase 2: Combination Regimen - Cohort 4 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
|
|
| OG002 | Phase 2: Combination Regimen - Cohort 3 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG003 | Phase 2: Combination Regimen - Cohort 4 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
|
|
| OG002 | Phase 1: Dose Escalation - 90 mg | The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase. Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. |
| OG003 | Phase 2: Combination Regimen - Cohort 1 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG004 | Phase 2: Combination Regimen - Cohort 2 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG005 | Phase 2: Combination Regimen - Cohort 3 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG006 | Phase 2: Combination Regimen - Cohort 4 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
|
|
| Phase 1: Dose Escalation - 90 mg |
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase. Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. |
| OG003 | Phase 2: Combination Regimen - Cohort 1 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG004 | Phase 2: Combination Regimen - Cohort 2 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG005 | Phase 2: Combination Regimen - Cohort 3 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG006 | Phase 2: Combination Regimen - Cohort 4 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
|
|
| OG003 | Phase 2: Combination Regimen - Cohort 1 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG004 | Phase 2: Combination Regimen - Cohort 2 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG005 | Phase 2: Combination Regimen - Cohort 3 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG006 | Phase 2: Combination Regimen - Cohort 4 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
|
|
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase. Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. |
| OG003 | Phase 2: Combination Regimen - Cohort 1 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG004 | Phase 2: Combination Regimen - Cohort 2 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG005 | Phase 2: Combination Regimen - Cohort 3 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG006 | Phase 2: Combination Regimen - Cohort 4 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
|
|
| OG002 | Phase 1: Mocetinostat 90 mg | The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase. Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. |
| OG003 | Phase 1: Mocetinostat 40 mg | One participant in Phase 1 was de-escalated to 40 mg of mocetinostat. |
| OG004 | Phase 2: Mocetinostat 70 mg | Participants in Phase 2 who received the recommended Phase 2 dose of 70 mg of mocetinostat. |
| OG005 | Phase 2: Mocetinostat 50 mg | Six participants in Phase 2 were de-escalated to 50 mg of mocetinostat. |
|
|
|
| OG003 | Phase 2: Combination Regimen - Cohort 1 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG004 | Phase 2: Combination Regimen - Cohort 2 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG005 | Phase 2: Combination Regimen - Cohort 3 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG006 | Phase 2: Combination Regimen - Cohort 4 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
|
|
| OG003 | Phase 2: Combination Regimen - Cohort 1 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG004 | Phase 2: Combination Regimen - Cohort 2 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG005 | Phase 2: Combination Regimen - Cohort 3 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
| OG006 | Phase 2: Combination Regimen - Cohort 4 | 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. Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks. Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg). |
|
|
|
|
|
|
|
|
|
|
|
|