Trial · NCT02259114
A Dose-Finding Study of Birabresib (MK-8628), a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Adults With Selected Advanced Solid Tumors (MK-8628-003)
NCT02259114, Phase 1, Completed, Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2018-10-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Dose-Finding Study of Birabresib (MK-8628), a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Adults With Selected Advanced Solid Tumors (MK-8628-003). Trials, record NCT02259114. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02259114
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose-Finding Study of Birabresib (MK-8628), a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Adults With Selected Advanced Solid Tumors (MK-8628-003)
- NCT number
- NCT02259114
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 47 participants, actual
- Lead sponsor
- Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
NUT Midline Carcinoma, Triple Negative Breast Cancer, Non-small Cell Lung Cancer With Rearranged ALK Gene/Fusion Protein or KRAS Mutation, Castrate-resistant Prostate Cancer, CRPC, Pancreatic Ductal Adenocarcinoma
- Interventions
- Birabresib
- First posted
- 2014-10-08
- Last updated
- 2021-01-26
- Other registries' IDs
- eudract:2014-002680-15
- Results first posted
- 2018-10-01
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1 | Up to Cycle 1 Day 21 (Up to 21 days) | A DLT was defined as any of the following toxicities that were considered by the investigator to be related to MK-8628: Hematologic toxicity: Grade 4 hematologic toxicity or febrile neutropenia, Grade 3 neutropenia with infection, Grade 3 thrombocytopenia with bleeding or lasting \>7 days; Non-hematologic toxicity: Grade 3 or 4 non-hematologic toxicity (regardless of duration) unless it was not optimally managed with supportive care, Grade 3 or 4 laboratory abnormality, with or without symptoms, lasting \>48 hours, Intolerable Grade 2 non-hematologic toxicity resulting in study drug discontinuation or delay \>7 days with or without dose reduction, Designated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) liver test abnormalities; Treatment delay \>2 weeks or dose reduction requirement for initiating Cycle 2. |
| Secondary | Number of Participants Who Experienced at Least One Adverse Event (AE) | Up to approximately 17.5 months (Up to 30 days after last dose of study treatment) | An AE is defined as any untoward medical occurrence associated with use of study treatment in humans, whether or not considered treatment related. The number of participants who experienced at least one AE is presented. |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 16.5 months | The number of participants who discontinued study treatment due to an AE is presented. |
| Secondary | Best Overall Response as Assessed in Solid Tumors by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or in Castration-resistant Prostate Cancer (CRPC) by Prostate Cancer Clinical Trials Working Group (PCWG2) Response Criteria | Up to approximately 16.5 months | The best overall response was the best response recorded from the start of the study treatment until the end of treatment. RECIST 1.1 response categories included: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions; and Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. |
| Secondary | Observed Maximum Plasma Concentration (Cmax) of MK-8628 | Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdose | Blood samples were obtained at specified time points for pharmacokinetic (PK) analysis of the observed Cmax of MK-8628. The observed Cmax of MK-8628 after administration is presented. |
| Secondary | Time to Cmax (Tmax) of MK-8628 | Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdose | Blood samples were obtained at specified time points for PK analysis of the Tmax of MK-8628. The Tmax of MK-8628 after administration is presented. |
| Secondary | Area Under to Concentration-Time Curve From 0 to Infinity (AUC0-∞) of MK-8628 | Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdose | Blood samples were obtained at specified time points for PK analysis of the AUC0-∞ of MK-8628. The AUC0-first is AUC0-∞ which is derived from the post-hoc estimate of CL/F from the population model. The AUC0-∞ of MK-8628 after administration is presented. |
| Secondary | Volume of Distribution at Steady State (Vdss) of MK-8628 | Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdose | Blood samples were obtained at specified time points for PK analysis of the Vdss of MK-8628. The Vdss of MK-8628 after administration is presented. |
| Secondary | Terminal Half-Life (t1/2) of MK-8628 | Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdose | Blood samples were obtained at specified time points for PK analysis of the t1/2 of MK-8628. The t1/2 of MK-8628 after administration is presented. |
| Secondary | Total Plasma Clearance (CL) of MK-8628 | Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdose | Blood samples were obtained at specified time points for PK analysis of the CL of MK-8628. The CL of MK-8628 after administration is presented. |
Source ClinicalTrials.gov
Outcomes10
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 Experienced a Dose Limiting Toxicity (DLT) During Cycle 1 | Up to Cycle 1 Day 21 (Up to 21 days) | The DLT Evaluable Population consisted of all participants who received ≥85% of the planned dose of study treatment (18 days for Continuous Dosing Regimens, or 6 days for Days 1-7 Dosing Regimens) or experienced a DLT during the first 21-day cycle. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced at Least One Adverse Event (AE) | Up to approximately 17.5 months (Up to 30 days after last dose of study treatment) | The Safety Population consisted of all participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to approximately 16.5 months | The Safety Population consisted of all participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Best Overall Response as Assessed in Solid Tumors by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or in Castration-resistant Prostate Cancer (CRPC) by Prostate Cancer Clinical Trials Working Group (PCWG2) Response Criteria | Up to approximately 16.5 months | The Efficacy Population consisted of all participants who received ≥2 complete cycles (6 weeks) of study treatment and underwent baseline assessment and 1 on-study tumor assessment, or who discontinued early due to disease progression. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Observed Maximum Plasma Concentration (Cmax) of MK-8628 | Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdose | The Pharmacokinetics (PK) Population consisted of all participants who received MK-8628 on Cycle 1 Day 1 and had blood samples drawn for PK analyses. | μg/L | MEAN |
| SECONDARY | Time to Cmax (Tmax) of MK-8628 | Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdose | The PK Population consisted of all participants who received MK-8628 on Cycle 1 Day 1 and had blood samples drawn for PK analyses. | Hours | MEDIAN |
| SECONDARY | Area Under to Concentration-Time Curve From 0 to Infinity (AUC0-∞) of MK-8628 | Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdose | The PK Population consisted of all participants who received MK-8628 on Cycle 1 Day 1 and had blood samples drawn for PK analyses. | μg*h/L | MEAN |
| SECONDARY | Volume of Distribution at Steady State (Vdss) of MK-8628 | Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdose | The PK Population consisted of all participants who received MK-8628 on Cycle 1 Day 1 and had blood samples drawn for PK analyses. | Liters | MEAN |
| SECONDARY | Terminal Half-Life (t1/2) of MK-8628 | Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdose | The PK Population consisted of all participants who received MK-8628 on Cycle 1 Day 1 and had blood samples drawn for PK analyses. | Hours | MEAN |
| SECONDARY | Total Plasma Clearance (CL) of MK-8628 | Cycle 1 Day1: Predose; 0.25, 1, 2, 3 and 7 hours postdose | The PK Population consisted of all participants who received MK-8628 on Cycle 1 Day 1 and had blood samples drawn for PK analyses. | Liters/Hour | MEAN |
Source ClinicalTrials.gov
Results by group70
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 Experienced a Dose Limiting Toxicity (DLT) During Cycle 1 | MK-8628 Continuous Dosing Regimen 80 mg/Day | 4 | Participants | ||
| Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1 | MK-8628 Continuous Dosing Regimen 100 mg/Day | 2 | Participants | ||
| Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1 | MK-8628 Days 1-7 Dosing Regimen 100 mg/Day | 0 | Participants | ||
| Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1 | MK-8628 Days 1-7 Dosing Regimen 120 mg/Day | 0 | Participants | ||
| Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1 | MK-8628 Days 1-7 Dosing Regimen 160 mg/Day | 0 | Participants | ||
| Number of Participants Who Experienced at Least One Adverse Event (AE) | MK-8628 Continuous Dosing Regimen 80 mg/Day | 20 | Participants | ||
| Number of Participants Who Experienced at Least One Adverse Event (AE) | MK-8628 Continuous Dosing Regimen 100 mg/Day | 4 | Participants | ||
| Number of Participants Who Experienced at Least One Adverse Event (AE) | MK-8628 Days 1-7 Dosing Regimen 100 mg/Day | 13 | Participants | ||
| Number of Participants Who Experienced at Least One Adverse Event (AE) | MK-8628 Days 1-7 Dosing Regimen 120 mg/Day | 3 | Participants | ||
| Number of Participants Who Experienced at Least One Adverse Event (AE) | MK-8628 Days 1-7 Dosing Regimen 160 mg/Day | 6 | Participants |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MK-8628 Continuous Dosing Regimen 80 mg/Day | 21 | |
| Overall Study | STARTED | MK-8628 Continuous Dosing Regimen 100 mg/Day | 4 | |
| Overall Study | STARTED | MK-8628 Days 1-7 Dosing Regimen 100 mg/Day | 13 | |
| Overall Study | STARTED | MK-8628 Days 1-7 Dosing Regimen 120 mg/Day | 3 | |
| Overall Study | STARTED | MK-8628 Days 1-7 Dosing Regimen 160 mg/Day | 6 | |
| Overall Study | Treated | MK-8628 Continuous Dosing Regimen 80 mg/Day | 20 | |
| Overall Study | Treated | MK-8628 Continuous Dosing Regimen 100 mg/Day | 4 | |
| Overall Study | Treated | MK-8628 Days 1-7 Dosing Regimen 100 mg/Day | 13 | |
| Overall Study | Treated | MK-8628 Days 1-7 Dosing Regimen 120 mg/Day | 3 | |
| Overall Study | Treated | MK-8628 Days 1-7 Dosing Regimen 160 mg/Day | 6 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events585
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 | MK-8628 Continuous Dosing Regimen 80 mg/Day | 7 | 20 | 19 |
| other | Anaemia | Blood and lymphatic system disorders | MK-8628 Continuous Dosing Regimen 100 mg/Day | 2 | 4 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | MK-8628 Days 1-7 Dosing Regimen 100 mg/Day | 3 | 13 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | MK-8628 Days 1-7 Dosing Regimen 120 mg/Day | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | MK-8628 Days 1-7 Dosing Regimen 160 mg/Day | 1 | 6 | 3 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MK-8628 Continuous Dosing Regimen 80 mg/Day | 4 | 20 | 10 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MK-8628 Continuous Dosing Regimen 100 mg/Day | 0 | 4 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MK-8628 Days 1-7 Dosing Regimen 100 mg/Day | 0 | 13 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MK-8628 Days 1-7 Dosing Regimen 120 mg/Day | 0 | 3 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MK-8628 Days 1-7 Dosing Regimen 160 mg/Day | 0 | 6 | 0 |
1 to 10 of 585Source ClinicalTrials.gov
See all 585 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MK-8628 Continuous Dosing Regimen 80 mg/Day | 3 | 20 |
| Total, all-cause mortality | MK-8628 Continuous Dosing Regimen 100 mg/Day | 2 | 4 |
| Total, all-cause mortality | MK-8628 Days 1-7 Dosing Regimen 100 mg/Day | 1 | 13 |
| Total, all-cause mortality | MK-8628 Days 1-7 Dosing Regimen 120 mg/Day | 0 | 3 |
| Total, all-cause mortality | MK-8628 Days 1-7 Dosing Regimen 160 mg/Day | 0 | 6 |
| Total, other adverse events | MK-8628 Continuous Dosing Regimen 80 mg/Day | 20 | 20 |
| Total, other adverse events | MK-8628 Continuous Dosing Regimen 100 mg/Day | 4 | 4 |
| Total, other adverse events | MK-8628 Days 1-7 Dosing Regimen 100 mg/Day | 13 | 13 |
| Total, other adverse events | MK-8628 Days 1-7 Dosing Regimen 120 mg/Day | 3 | 3 |
| Total, other adverse events | MK-8628 Days 1-7 Dosing Regimen 160 mg/Day | 6 | 6 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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.
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