Trial · NCT02698189
A Dose Exploration Study With Birabresib (MK-8628) in Participants With Selected Hematologic Malignancies (MK-8628-005)
NCT02698189, Phase 1, Terminated, Merck Sharp & Dohme LLC; results first posted 2019-07-23
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ConductScience Library. A Dose Exploration Study With Birabresib (MK-8628) in Participants With Selected Hematologic Malignancies (MK-8628-005). Trials, record NCT02698189. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02698189
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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 Hematologic Malignancies (MK-8628-005)
- NCT number
- NCT02698189
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 9 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- AML Including AML de Novo and AML Secondary to MDS, DLBCL
- Interventions
- Birabresib Dose 20 mg
- First posted
- 2016-03-03
- Last updated
- 2022-09-13
- Other registries' IDs
- eudract:2015-005487-42
- Results first posted
- 2019-07-23
- Limitations and caveats
- Due to limited pharmacokinetics sampling for t1/2, caution must be exercised when interpreting the results of t1/2, CL/F, and AUC 0-∞ results.
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Dose Limiting Toxicity (DLT) | From time of first dose up to the end of Cycle 1 (21-day cycle): up to 21 days | DLT was any of the following drug related (DR) investigator-assessed adverse events: pancytopenia with hypocellular bone marrow and no marrow blasts lasting for ≥6 weeks; Grade (G)4 hematologic toxicity lasting ≥7 days except thrombocytopenia; G4 thrombocytopenia; G3 thrombocytopenia with bleeding; G3 or 4 febrile or infection-related neutropenia; G4 nonhematologic (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; increases in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin, or international normalization ratio indicative of significant liver impairment; 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 | Percentage of Participants Who Experienced At Least One Adverse Event (AE) | From time of first dose until the end of follow-up (up to 8 months) | An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of all participants who experienced at least one AE is presented. Per protocol, these results are based on a data cutoff date of 09-May-2018. |
| Secondary | Percentage of Participants Who Discontinued Study Treatment Due to an AE | From time of first dose until the end of treatment (up to 7 months) | An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE. The percentage of all participants who discontinued study treatment due to an AE is presented. Per protocol, these results are based on a data cutoff date of 09-May-2018. |
| Secondary | Objective Response Rate (ORR) in the Acute Myeloid Leukemia (AML) Cohort Per International Working Group Criteria: European LeukemiaNet (Döhner et al, Blood, 2010) | Every 3 weeks starting from Cycle 2 (21-day cycle) until disease progression (up to 7 months) | ORR was defined as the percentage of the participants who had complete response (CR) or partial response (PR) as assessed by investigator review. Participants in the AML cohort were assessed using bone marrow aspiration and hematologic criteria and response was evaluated based on European LeukemiaNet (Döhner et al, Blood, 2010). The criteria for complete response included: bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 × 10\^9/Liter; platelet count \>100 × 10\^9/Liter; and independence of red cell transfusions. The criteria for partial response included: decrease of bone marrow blast percentage to 5% to 25%; decrease of pretreatment bone marrow blast percentage by at least 50%; and all hematologic criteria associated with CR. The percentage of participants who achieved CR or PR is presented. |
| Secondary | Objective Response Rate (ORR) in the Diffuse Large B Cell Lymphoma (DLBCL) Cohort Per International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014) | Every 12 weeks starting from Cycle 5 (21-day cycle) until disease progression (up to 7 months) | ORR was defined as the percentage of the participants who had complete response (CR) or partial response (PR) as assessed by investigator review. Participants in the DLBCL cohort were assessed using computed tomography (CT) and positron emission tomography (PET)-CT and response was evaluated based on the Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). The criteria for CR included complete metabolic (no/minimal fluorodeoxyglucose \[FDG\] uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. The criteria for PR included: partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of the product of the perpendicular diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). The percentage of participants who achieved CR or PR is presented. |
| Secondary | Duration of Response (DOR) in the Acute Myeloid Leukemia (AML) Cohort Per International Working Group Criteria: European LeukemiaNet (Döhner et al, Blood, 2010) | Every 3 weeks starting from Cycle 2 (21-day cycle) until disease progression (up to 7 months) | DOR was defined as the time from complete response (CR) or partial response (PR) to documented disease progression or death as assessed by investigator review. Participants in the AML cohort were assessed using bone marrow aspiration and hematologic criteria and response was evaluated based on European LeukemiaNet (Döhner et al, Blood, 2010). The criteria for complete response included: bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 × 10\^9/Liter; platelet count \>100 × 10\^9/Liter; and independence of red cell transfusions. The criteria for partial response included: decrease of bone marrow blast percentage to 5% to 25%; decrease of pretreatment bone marrow blast percentage by at least 50%; and all hematologic criteria associated with CR. |
| Secondary | Duration of Response (DOR) in the Diffuse Large B Cell Lymphoma (DLBCL) Cohort Per International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014) | Every 12 weeks starting from Cycle 5 (21-day cycle) until disease progression (up to 7 months) | DOR was defined as the time from complete response (CR) or partial response (PR) to documented disease progression or death as assessed by investigator review. Participants in the DLBCL cohort were assessed using computed tomography (CT) and positron emission tomography (PET)-CT and response was evaluated based on the Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). The criteria for CR included complete metabolic (no/minimal fluorodeoxyglucose \[FDG\] uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. The criteria for PR included: partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of the product of the perpendicular diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). |
| Secondary | Disease Control Rate (DCR) in the Acute Myeloid Leukemia (AML) Cohort Per International Working Group Criteria: European LeukemiaNet (Döhner et al, Blood, 2010) | Every 3 weeks starting from Cycle 2 (21-day cycle) until disease progression (up to 7 months) | DCR was defined as the percentage of the participants who had stable disease, complete response (CR) or partial response (PR) as assessed by investigator review. Participants in the AML cohort were assessed using bone marrow aspiration and hematologic criteria and response was evaluated based on European LeukemiaNet (Döhner et al, Blood, 2010). The criteria for complete response included: bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0 × 10\^9/Liter; platelet count \>100 × 10\^9/Liter; and independence of red cell transfusions. The criteria for partial response included: decrease of bone marrow blast percentage to 5% to 25%; decrease of pretreatment bone marrow blast percentage by at least 50%; and all hematologic criteria associated with CR. |
| Secondary | Disease Control Rate (DCR) in the Diffuse Large B Cell Lymphoma (DLBCL) Cohort Per International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014) | Every 12 weeks starting from Cycle 5 (21-day cycle) until disease progression (up to 7 months) | DCR was defined as the percentage of the participants in the DLBCL cohort who had stable disease, complete response (CR) or partial response (PR) as assessed by investigator review. Participants in the DLBCL cohort were assessed using computed tomography (CT) and positron emission tomography (PET)-CT and response was evaluated based on the Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). The criteria for CR included complete metabolic (no/minimal fluorodeoxyglucose \[FDG\] uptake) and radiologic response (target lesions regress to ≤5 cm in longest transverse diameter of a lesion) and no new lesions. The criteria for PR included: partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of the product of the perpendicular diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). |
| Secondary | Observed Maximum Concentration (Cmax) of MK-8628 | Up to 22 days post MK-8628 dose | Blood samples were collected to determine Cmax at the following time points: Cycle 1 (21-day cycle) Day 1 at predose and 20 minutes, 1 hour, 2.25 hours, 3.25 hours, 8 hours and 12 hours postdose; Cycle 1 (21-day cycle) at predose on Days 8 and 15; and Cycle 2 (21-day cycle) at predose on Day 1. Per protocol, Cmax for MK-8628 was assessed across all study participants by dose and this assessment was not related to any specific disease cohort. The Cmax of MK-8628 after oral administration is presented for participants pooled from the AML and DLBCL cohorts since both cohorts received the same dose. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Dose Limiting Toxicity (DLT) | From time of first dose up to the end of Cycle 1 (21-day cycle): up to 21 days | The population consisted of all participants that received at least 85% of the planned dose of study drug (18 days) or experienced a DLT during Cycle 1 (21-day cycle). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced At Least One Adverse Event (AE) | From time of first dose until the end of follow-up (up to 8 months) | The analysis population consisted of all participants who received at least one dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Discontinued Study Treatment Due to an AE | From time of first dose until the end of treatment (up to 7 months) | The analysis population consisted of all participants who received at least one dose of study treatment. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) in the Acute Myeloid Leukemia (AML) Cohort Per International Working Group Criteria: European LeukemiaNet (Döhner et al, Blood, 2010) | Every 3 weeks starting from Cycle 2 (21-day cycle) until disease progression (up to 7 months) | The analysis population consisted of all participants in the AML cohort who received at least one dose of study treatment and had data evaluable for ORR analysis. | Percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) in the Diffuse Large B Cell Lymphoma (DLBCL) Cohort Per International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014) | Every 12 weeks starting from Cycle 5 (21-day cycle) until disease progression (up to 7 months) | The analysis population consisted of all participants in the DLBCL cohort who received at least one dose of study treatment and had data evaluable for ORR analysis. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) in the Acute Myeloid Leukemia (AML) Cohort Per International Working Group Criteria: European LeukemiaNet (Döhner et al, Blood, 2010) | Every 3 weeks starting from Cycle 2 (21-day cycle) until disease progression (up to 7 months) | The analysis population consisted of all participants in the AML cohort who received at least one dose of study treatment and had data evaluable for DOR analysis. DOR could not be calculated because no participants met criteria for analysis: CR or PR and documented disease progression or death. | ||
| SECONDARY | Duration of Response (DOR) in the Diffuse Large B Cell Lymphoma (DLBCL) Cohort Per International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014) | Every 12 weeks starting from Cycle 5 (21-day cycle) until disease progression (up to 7 months) | The analysis population consisted of all participants in the DLBCL cohort who received at least one dose of study treatment and had data evaluable for DOR analysis. DOR could not be calculated because no participants met criteria for analysis: CR or PR and documented disease progression or death. | ||
| SECONDARY | Disease Control Rate (DCR) in the Acute Myeloid Leukemia (AML) Cohort Per International Working Group Criteria: European LeukemiaNet (Döhner et al, Blood, 2010) | Every 3 weeks starting from Cycle 2 (21-day cycle) until disease progression (up to 7 months) | The analysis population consisted of all participants in the AML cohort who received at least one dose of study treatment and had data evaluable for DCR analysis. | Percentage of participants | NUMBER |
| SECONDARY | Disease Control Rate (DCR) in the Diffuse Large B Cell Lymphoma (DLBCL) Cohort Per International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014) | Every 12 weeks starting from Cycle 5 (21-day cycle) until disease progression (up to 7 months) | The analysis population consisted of all participants in the DLBCL cohort who received at least one dose of study treatment and had data evaluable for DCR analysis. | Percentage of participants | NUMBER |
| SECONDARY | Observed Maximum Concentration (Cmax) of MK-8628 | Up to 22 days post MK-8628 dose | The analysis population consisted of the total number of participants pooled from both cohorts (AML and DLBCL) who received at least one dose of MK-8628 20 mg and had data available for Cmax analysis. | ng/mL | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group219
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Dose Limiting Toxicity (DLT) | MK-8628 20 mg AML Cohort | 0.00 | Percentage of participants | ||
| Percentage of Participants With a Dose Limiting Toxicity (DLT) | MK-8628 20 mg DLBCL Cohort | 16.67 | Percentage of participants | ||
| Percentage of Participants Who Experienced At Least One Adverse Event (AE) | MK-8628 20 mg AML Cohort | 100.0 | Percentage of participants | ||
| Percentage of Participants Who Experienced At Least One Adverse Event (AE) | MK-8628 20 mg DLBCL Cohort | 100.0 | Percentage of participants | ||
| Percentage of Participants Who Discontinued Study Treatment Due to an AE | MK-8628 20 mg AML Cohort | 0.0 | Percentage of participants | ||
| Percentage of Participants Who Discontinued Study Treatment Due to an AE | MK-8628 20 mg DLBCL Cohort | 0.0 | Percentage of participants | ||
| Objective Response Rate (ORR) in the Acute Myeloid Leukemia (AML) Cohort Per International Working Group Criteria: European LeukemiaNet (Döhner et al, Blood, 2010) | MK-8628 20 mg AML Cohort | Complete response | 0.0 | 95% Confidence Interval 0.0 to 70.8 | Percentage of participants |
| Objective Response Rate (ORR) in the Acute Myeloid Leukemia (AML) Cohort Per International Working Group Criteria: European LeukemiaNet (Döhner et al, Blood, 2010) | MK-8628 20 mg AML Cohort | Partial response | 0.0 | 95% Confidence Interval 0.0 to 70.8 | Percentage of participants |
| Objective Response Rate (ORR) in the Diffuse Large B Cell Lymphoma (DLBCL) Cohort Per International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014) | MK-8628 20 mg DLBCL Cohort | Complete response | 0.0 | 95% Confidence Interval 0.0 to 45.9 | Percentage of participants |
| Objective Response Rate (ORR) in the Diffuse Large B Cell Lymphoma (DLBCL) Cohort Per International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014) | MK-8628 20 mg DLBCL Cohort | Partial response | 16.7 | 95% Confidence Interval 0.4 to 64.1 | Percentage of participants |
1 to 10 of 219Source ClinicalTrials.gov
See all 219 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MK-8628 20 mg Acute Myeloid Leukemia (AML) Cohort | 3 | |
| Overall Study | STARTED | MK-8628 20 mg Diffuse Large B Cell Lymphoma (DLBCL) Cohort | 6 | |
| Overall Study | COMPLETED | MK-8628 20 mg Acute Myeloid Leukemia (AML) Cohort | 0 | |
| Overall Study | COMPLETED | MK-8628 20 mg Diffuse Large B Cell Lymphoma (DLBCL) Cohort | 0 | |
| Overall Study | NOT COMPLETED | MK-8628 20 mg Acute Myeloid Leukemia (AML) Cohort | 3 | |
| Overall Study | NOT COMPLETED | MK-8628 20 mg Diffuse Large B Cell Lymphoma (DLBCL) Cohort | 6 |
Source ClinicalTrials.gov
Adverse events194
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 AML Cohort | 2 | 3 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | MK-8628 20 mg DLBCL Cohort | 2 | 6 | 4 |
| other | Lymphopenia | Blood and lymphatic system disorders | MK-8628 20 mg AML Cohort | 0 | 3 | 0 |
| other | Lymphopenia | Blood and lymphatic system disorders | MK-8628 20 mg DLBCL Cohort | 1 | 6 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | MK-8628 20 mg AML Cohort | 1 | 3 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | MK-8628 20 mg DLBCL Cohort | 1 | 6 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MK-8628 20 mg AML Cohort | 2 | 3 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MK-8628 20 mg DLBCL Cohort | 3 | 6 | 6 |
| other | Tachycardia | Cardiac disorders | MK-8628 20 mg AML Cohort | 2 | 3 | 2 |
| other | Tachycardia | Cardiac disorders | MK-8628 20 mg DLBCL Cohort | 0 | 6 | 0 |
1 to 10 of 194Source ClinicalTrials.gov
See all 194 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MK-8628 20 mg AML Cohort | 3 | 3 |
| Total, all-cause mortality | MK-8628 20 mg DLBCL Cohort | 0 | 6 |
| Total, other adverse events | MK-8628 20 mg AML Cohort | 3 | 3 |
| Total, other adverse events | MK-8628 20 mg DLBCL Cohort | 6 | 6 |
| Total, serious adverse events | MK-8628 20 mg AML Cohort | 3 | 3 |
| Total, serious adverse events | MK-8628 20 mg DLBCL Cohort | 1 | 6 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MK-8628 20 mg AML Cohort vs MK-8628 20 mg DLBCL Cohort: deaths from any cause | Trial comparisons |
| MK-8628 20 mg AML Cohort vs MK-8628 20 mg DLBCL Cohort: serious adverse events | Trial comparisons |
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.
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