Trial · NCT02698176
A Dose Exploration Study With Birabresib (MK-8628) in Participants With Selected Advanced Solid Tumors (MK-8628-006)
NCT02698176, Phase 1, Terminated, Merck Sharp & Dohme LLC; results first posted 2018-11-05
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. A Dose Exploration Study With Birabresib (MK-8628) in Participants With Selected Advanced Solid Tumors (MK-8628-006). Trials, record NCT02698176. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02698176
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Dose Exploration Study With Birabresib (MK-8628) in Participants With Selected Advanced Solid Tumors (MK-8628-006)
- NCT number
- NCT02698176
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 13 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- NUT Midline Carcinoma (NMC), Triple Negative Breast Cancer (TNBC), Non-small Cell Lung Cancer (NSCLC), Castration-resistant Prostate Cancer (CRPC)
- Interventions
- Birabresib
- First posted
- 2016-03-03
- Last updated
- 2021-01-27
- Other registries' IDs
- eudract:2015-005488-18
- Results first posted
- 2018-11-05
- Limitations and caveats
The study was terminated due to limited efficacy and not due to safety reasons. Due to limited PK sampling for t1/2, caution must be exercised when interpreting the results of t1/2, CL/F, and AUC 0-∞ values.
Source ClinicalTrials.gov
Registered outcomes13
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 | From time of first dose up to the end of the first cycle (up to 21 days) | A DLT was any of the following deemed drug related (DR) by investigator: Grade (G)4 hematologic toxicity lasting ≥7 days except thrombocytopenia; G4 thrombocytopenia; G3 thrombocytopenia with bleeding; G3 or 4 febrile neutropenia. G4 non-hematologic (NH) toxicity (not laboratory); G3 NH toxicity (not laboratory), nausea, vomiting, or diarrhea lasting \>3 days despite supportive care; G3 or 4 NH laboratory abnormality requiring medical intervention, hospitalization, or persisting \>1 week; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>8X Upper Limit of Normal(ULN); ALT or AST \>5XULN for \>2 weeks; ALT or AST \>3XULN and total bilirubin \>2XULN or international normalization ratio \>1.5; ALT or AST \>3XULN with fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash and/or eosinophilia (\>5%); DR adverse event leading to discontinuation or \>20% missed planned doses in Cycle 1; DR toxicity causing \>2 week delay in starting Cycle 2; or G5 toxicity. |
| Secondary | Number of Participants Who Experienced at Least One Adverse Event (AE) | From time of first dose until the end of the 30-day follow-up (up to 25 months) | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. The number of participants who experienced at least one AE is presented. |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to an AE | From time of first dose until the end of treatment (up to 24 months) | The number of participants who discontinued study treatment due to an AE is presented. |
| Secondary | Objective Response Rate (ORR) | Assessed every 6 weeks from time of first dose until disease progression (up to 24 months) | ORR was defined as the percentage of the participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1) and lack of progression according to the guidelines for prostate cancer endpoints developed by Prostate Cancer Clinical Trials Working Group (PCWG) 2 as assessed by investigator radiologic review. The number of participants who achieved a CR or PR is presented. |
| Secondary | Duration of Response (DOR) | Assessed every 6 weeks from time of first dose until disease progression (up to 24 months) | For participants who demonstrated CR or PR, DOR was defined as the time from first documented evidence of CR or PR per RECIST 1.1 until disease progression per RECIST 1.1 and PCWG2 or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions was also considered progression per RECIST 1.1. Per PCWG2, progressive disease was defined as a confirmed increase of at least two new lesions on a bone scan. DOR assessments were assessed by investigator radiologic review. The DOR for all participants who experienced a CR or PR is presented. |
| Secondary | Disease Control Rate (DCR) | Assessed every 6 weeks from time of first dose until disease progression (up to 24 months) | DCR was defined as the number of subjects with CR, PR, or stable disease (SD) as assessed by investigator radiologic review according to RECIST version 1.1 and PCWG2. CR: defined as disappearance of all target and all non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than \<10 mm per RECIST 1.1. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters along with absence of new lesions and disease progression in non-target lesions per RECIST 1.1. SD: defined as, neither sufficient shrinkage to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study per RECIST 1.1 and lack of a confirmed increase of at least two new lesions on a bone scan per PCWG2. The number of participants who experienced DCR is presented. |
| Secondary | Observed Maximum Concentration (Cmax) of MK-8628 | Cycle1/Day 1: predose, 20 minutes, 1 hour, 2.25 hours (hrs), 3.25 hrs, 8 hrs, and 12 hrs postdose | Blood samples were obtained at specified time points for the pharmacokinetic (PK) analysis of Cmax of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry. The Cmax of MK-8628 after oral administration is presented. |
| Secondary | Observed Minimum Concentration (Cmin) of MK-8628 | Cycle1/Day 1: predose, 20 minutes, 1 hour, 2.25 hours (hrs), 3.25 hrs, 8 hrs, and 12 hrs postdose | Blood samples were obtained at specified time points for the PK analysis of Cmin of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry. The Cmin of MK-8628 after oral administration is presented. |
| Secondary | Time to Maximum Concentration (Tmax) of MK-8628 | Cycle1/Day 1: predose, 20 minutes, 1 hour, 2.25 hours (hrs), 3.25 hrs, 8 hrs, and 12 hrs postdose | Blood samples were obtained at specified time points for the PK analysis of Tmax of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry. The Tmax of MK-8628 after oral administration is presented. |
| Secondary | Apparent Terminal Half-Life (t1/2) of MK-8628 | Cycle1/Day 1: predose, 20 minutes, 1 hour, 2.25 hours (hrs), 3.25 hrs, 8 hrs, and 12 hrs postdose | Blood samples were obtained at specified time points for the PK analysis of t1/2 of MK-8628. MK-8628 concentrations were analyzed using ultra-performance liquid chromatography coupled with a tandem mass spectrometry. The t1/2 of MK-8628 after oral administration is presented. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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 | From time of first dose up to the end of the first cycle (up to 21 days) | Participants in Part A of the study that received at least 85% of the planned MK-8628 20 mg dose (18 days) 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) | From time of first dose until the end of the 30-day follow-up (up to 25 months) | Participants in Part A of the study that received at least 1 dose of MK-8628 20 mg. No participants were enrolled in Part B of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to an AE | From time of first dose until the end of treatment (up to 24 months) | Participants in Part A of the study that received at least 1 dose of MK-8628 20 mg. No participants were enrolled in Part B of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Objective Response Rate (ORR) | Assessed every 6 weeks from time of first dose until disease progression (up to 24 months) | Participants in Part A of the study who received at least one dose of MK-8628 20 mg. No participants were enrolled in Part B of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) | Assessed every 6 weeks from time of first dose until disease progression (up to 24 months) | Participants in Part A of the study who received at least one dose of MK-8628 20 mg. No participants were enrolled in Part B of the study. Since no participants experienced a CR or PR, DOR could not be calculated. | ||
| SECONDARY | Disease Control Rate (DCR) | Assessed every 6 weeks from time of first dose until disease progression (up to 24 months) | Participants in Part A of the study who received at least one dose of MK-8628 20 mg. No participants were enrolled in Part B of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Observed Maximum Concentration (Cmax) of MK-8628 | Cycle1/Day 1: predose, 20 minutes, 1 hour, 2.25 hours (hrs), 3.25 hrs, 8 hrs, and 12 hrs postdose | Total number of participants from all 3 cohorts (CRPC+NMC+TNBC) in Part A of the study that received at least 1 dose of MK-8628 20 mg and had data available for the PK parameter being analyzed. | ng/mL | MEAN |
| SECONDARY | Observed Minimum Concentration (Cmin) of MK-8628 | Cycle1/Day 1: predose, 20 minutes, 1 hour, 2.25 hours (hrs), 3.25 hrs, 8 hrs, and 12 hrs postdose | Total number of participants from all 3 cohorts (CRPC+NMC+TNBC) in Part A of the study that received at least 1 dose of MK-8628 20 mg and had data available for the PK parameter being analyzed. | ng/mL | MEAN |
| SECONDARY | Time to Maximum Concentration (Tmax) of MK-8628 | Cycle1/Day 1: predose, 20 minutes, 1 hour, 2.25 hours (hrs), 3.25 hrs, 8 hrs, and 12 hrs postdose | Total number of participants from all 3 cohorts (CRPC+NMC+TNBC) in Part A of the study that received at least 1 dose of MK-8628 20 mg and had data available for the PK parameter being analyzed. | hours | MEDIAN |
| SECONDARY | Apparent Terminal Half-Life (t1/2) of MK-8628 | Cycle1/Day 1: predose, 20 minutes, 1 hour, 2.25 hours (hrs), 3.25 hrs, 8 hrs, and 12 hrs postdose | Total number of participants from all 3 cohorts (CRPC+NMC+TNBC) in Part A of the study that received at least 1 dose of MK-8628 20 mg and had data available for the PK parameter being analyzed. | hours | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group22
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 20 mg CRPC Cohort-Part A | 2 | Participants | ||
| Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1 | MK-8628 20 mg NMC Cohort-Part A | 1 | Participants | ||
| Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1 | MK-8628 20 mg TNBC Cohort-Part A | 0 | Participants | ||
| Number of Participants Who Experienced at Least One Adverse Event (AE) | MK-8628 20 mg CRPC Cohort-Part A | 9 | Participants | ||
| Number of Participants Who Experienced at Least One Adverse Event (AE) | MK-8628 20 mg NMC Cohort-Part A | 3 | Participants | ||
| Number of Participants Who Experienced at Least One Adverse Event (AE) | MK-8628 20 mg TNBC Cohort-Part A | 1 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an AE | MK-8628 20 mg CRPC Cohort-Part A | 2 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an AE | MK-8628 20 mg NMC Cohort-Part A | 0 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an AE | MK-8628 20 mg TNBC Cohort-Part A | 0 | Participants | ||
| Objective Response Rate (ORR) | MK-8628 20 mg CRPC Cohort-Part A | 0 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MK-8628 20 mg CRPC Cohort-Part A | 9 | |
| Overall Study | STARTED | MK-8628 20 mg NMC Cohort-Part A | 3 | |
| Overall Study | STARTED | MK-8628 20 mg TNBC Cohort-Part A | 1 | |
| Overall Study | STARTED | NMC Cohort-Part B | 0 | |
| Overall Study | COMPLETED | MK-8628 20 mg CRPC Cohort-Part A | 0 | |
| Overall Study | COMPLETED | MK-8628 20 mg NMC Cohort-Part A | 0 | |
| Overall Study | COMPLETED | MK-8628 20 mg TNBC Cohort-Part A | 0 | |
| Overall Study | COMPLETED | NMC Cohort-Part B | 0 | |
| Overall Study | NOT COMPLETED | MK-8628 20 mg CRPC Cohort-Part A | 9 | |
| Overall Study | NOT COMPLETED | MK-8628 20 mg NMC Cohort-Part A | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events195
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 20 mg CRPC Cohort-Part A | 2 | 9 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | MK-8628 20 mg NMC Cohort-Part A | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | MK-8628 20 mg TNBC Cohort-Part A | 0 | 1 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | MK-8628 20 mg CRPC Cohort-Part A | 1 | 9 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | MK-8628 20 mg NMC Cohort-Part A | 0 | 3 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | MK-8628 20 mg TNBC Cohort-Part A | 0 | 1 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | MK-8628 20 mg CRPC Cohort-Part A | 0 | 9 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | MK-8628 20 mg NMC Cohort-Part A | 0 | 3 | 0 |
| other | Leukopenia | Blood and lymphatic system disorders | MK-8628 20 mg TNBC Cohort-Part A | 1 | 1 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MK-8628 20 mg CRPC Cohort-Part A | 2 | 9 | 2 |
1 to 10 of 195Source ClinicalTrials.gov
See all 195 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MK-8628 20 mg CRPC Cohort-Part A | 0 | 9 |
| Total, all-cause mortality | MK-8628 20 mg NMC Cohort-Part A | 0 | 3 |
| Total, all-cause mortality | MK-8628 20 mg TNBC Cohort-Part A | 0 | 1 |
| Total, other adverse events | MK-8628 20 mg CRPC Cohort-Part A | 9 | 9 |
| Total, other adverse events | MK-8628 20 mg NMC Cohort-Part A | 3 | 3 |
| Total, other adverse events | MK-8628 20 mg TNBC Cohort-Part A | 1 | 1 |
| Total, serious adverse events | MK-8628 20 mg CRPC Cohort-Part A | 3 | 9 |
| Total, serious adverse events | MK-8628 20 mg NMC Cohort-Part A | 2 | 3 |
| Total, serious adverse events | MK-8628 20 mg TNBC Cohort-Part A | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02698176
GET https://conductscience.org/api/trials/v1/NCT02698176/results?page=2