Trial · NCT02296476
A Dose-finding Study of Birabresib (MK-8628) in Participants With Recurrent Glioblastoma Multiforme (MK-8628-002)
NCT02296476, Phase 2, Terminated, Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2018-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Dose-finding Study of Birabresib (MK-8628) in Participants With Recurrent Glioblastoma Multiforme (MK-8628-002). Trials, record NCT02296476. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02296476
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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) in Participants With Recurrent Glioblastoma Multiforme (MK-8628-002)
- NCT number
- NCT02296476
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Oncoethix GmbH, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Glioblastoma Multiforme
- Interventions
- Birabresib
- First posted
- 2014-11-20
- Last updated
- 2021-01-26
- Other registries' IDs
- eudract:2014-001469-28
- Results first posted
- 2018-05-17
- Limitations and caveats
- This study was terminated 31-Aug-2015 because no clinical activity was detected. The study was not terminated due to safety reasons.
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) at 6 Months | Month 6 | Progression-free survival was the time from the start of study treatment to the date of clinical or radiographic evidence of progressive disease according to Response Assessment in Neuro-Oncology (RANO) 2010 criteria or death. Progression, as assessed by RANO 2010, was defined as a ≥25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. PFS at 6 months was measured as the percentage of participants who were alive and progression-free at Month 6. PFS at 6 months was calculated for all participants who were actively enrolled in the study at the 6-month time point. |
| Secondary | Objective Response Rate (ORR) | Up to 6 Months | ORR was defined as the number of participants in the analysis population who experienced a Complete Response (CR: complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks; no new lesions; no corticosteroids; and stable or improved clinically) or a Partial Response (PR: ≥50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; no new lesions; stable or reduced corticosteroid dose; and stable or improved clinically) and was assessed using RANO 2010. |
| Secondary | Duration of Response (DOR) | Up to 6 Months | DOR was the time from the first documented CR (complete disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks; no new lesions; no corticosteroids; and stable or improved clinically)or PR (≥50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks; no new lesions; stable or reduced corticosteroid dose; and stable or improved clinically), as assessed by RANO 2010, until documentation of disease progression, or the date of the last tumor assessment (if there was no documented progression), or the last tumor assessment before the start of further antitumor therapy. DOR was calculated for all participants who experienced a CR or PR. |
| Secondary | Overall Survival (OS) | Up to 6 Months | OS was the time from the start of study treatment to the date of death. Participants were to be censored at their last contact if they were still alive at the cut-off date. OS was calculated for all participants who did not discontinue from the study due to disease progression. |
| Secondary | Progression-free Survival | Up to 6 Months | Progression-free survival was the time from the start of study treatment to the date of clinical or radiographic evidence of progressive disease according to RANO 2010 criteria or death. Progression, as assessed by RANO 2010, was defined as a ≥25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. PFS was measured as the number of participants who were alive and progression-free for up to 6 months. |
| Secondary | Number of Participants Who Experienced at Least One Adverse Event (AE) | Up to 6 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 Experienced at Least One Toxicity Grade 3-5 AE | Up to 6 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. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. The number of participants who experienced ≥1 Grade 3-5 AE per National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03 criteria is presented. Grade 3 was classified as severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care; Grade 4 was classified as potentially life-threatening or disabling; and Grade 5 was an AE resulting in death. |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to an AE | Up to 6 Months | The number of participants who discontinued study treatment due to an AE is presented. |
| Secondary | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1 | Up to Cycle 1 (Up to 28 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 lasting \>7 days, or intolerable Grade 2 non-hematologic toxicity resulting in study treatment discontinuation or delay \>7 days with or without dose reduction. |
| Secondary | Observed Maximum Concentration (Cmax) of MK-8628 | Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours 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 and Cmax was calculated using the nonlinear mixed-effects modelling software program Monolix version 4.3.2s. The Cmax of MK-8628 after oral administration is presented. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival (PFS) at 6 Months | Month 6 | All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study magnetic resonance imaging (MRI). Since no participants reached the 6-month time point in the study, PFS at 6 months could not be calculated. | ||
| SECONDARY | Objective Response Rate (ORR) | Up to 6 Months | All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) | Up to 6 Months | All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression. Since no participants experienced a CR or PR, DOR could not be calculated. | ||
| SECONDARY | Overall Survival (OS) | Up to 6 Months | All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression. Since all participants discontinued the study due to disease progression, OS could not be calculated. | ||
| SECONDARY | Progression-free Survival | Up to 6 Months | All participants who received at least 2 complete cycles (8 weeks) of treatment and had a baseline assessment and 1 on-study MRI or had discontinued early due to disease progression. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced at Least One Adverse Event (AE) | Up to 6 Months | All participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced at Least One Toxicity Grade 3-5 AE | Up to 6 Months | 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 6 Months | All participants who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT) During Cycle 1 | Up to Cycle 1 (Up to 28 days) | All participants who received at least 21 days of the planned dose of study drug during the first 28-day cycle or experienced a DLT. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Observed Maximum Concentration (Cmax) of MK-8628 | Day 1: Predose and 0.25, 1, 2, 3, 7, and 8 hours postdose | All participants who received MK-8628 and had blood samples drawn for PK analyses. | μg/Liter | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | MK-8628 80 mg | 0 | Participants | ||
| Objective Response Rate (ORR) | MK-8628 120 mg | 0 | Participants | ||
| Objective Response Rate (ORR) | MK-8628 160 mg | 0 | Participants | ||
| Progression-free Survival | MK-8628 80 mg | 0 | Participants | ||
| Progression-free Survival | MK-8628 120 mg | 0 | Participants | ||
| Progression-free Survival | MK-8628 160 mg | 0 | Participants | ||
| Number of Participants Who Experienced at Least One Adverse Event (AE) | MK-8628 80 mg | 6 | Participants | ||
| Number of Participants Who Experienced at Least One Adverse Event (AE) | MK-8628 120 mg | 4 | Participants | ||
| Number of Participants Who Experienced at Least One Adverse Event (AE) | MK-8628 160 mg | 2 | Participants | ||
| Number of Participants Who Experienced at Least One Toxicity Grade 3-5 AE | MK-8628 80 mg | 3 | Participants |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MK-8628 80 mg | 6 | |
| Overall Study | STARTED | MK-8628 120 mg | 4 | |
| Overall Study | STARTED | MK-8628 160 mg | 2 | |
| Overall Study | COMPLETED | MK-8628 80 mg | 0 | |
| Overall Study | COMPLETED | MK-8628 120 mg | 0 | |
| Overall Study | COMPLETED | MK-8628 160 mg | 0 | |
| Overall Study | NOT COMPLETED | MK-8628 80 mg | 6 | |
| Overall Study | NOT COMPLETED | MK-8628 120 mg | 4 | |
| Overall Study | NOT COMPLETED | MK-8628 160 mg | 2 |
Source ClinicalTrials.gov
Adverse events144
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 | Thrombocytopenia | Blood and lymphatic system disorders | MK-8628 80 mg | 1 | 6 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MK-8628 120 mg | 1 | 4 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | MK-8628 160 mg | 1 | 2 | 1 |
| other | Ear pain | Ear and labyrinth disorders | MK-8628 80 mg | 0 | 6 | 0 |
| other | Ear pain | Ear and labyrinth disorders | MK-8628 120 mg | 1 | 4 | 1 |
| other | Ear pain | Ear and labyrinth disorders | MK-8628 160 mg | 0 | 2 | 0 |
| other | Vertigo | Ear and labyrinth disorders | MK-8628 80 mg | 0 | 6 | 0 |
| other | Vertigo | Ear and labyrinth disorders | MK-8628 120 mg | 1 | 4 | 1 |
| other | Vertigo | Ear and labyrinth disorders | MK-8628 160 mg | 0 | 2 | 0 |
| other | Ocular icterus | Eye disorders | MK-8628 80 mg | 0 | 6 | 0 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MK-8628 80 mg | 0 | 6 |
| Total, all-cause mortality | MK-8628 120 mg | 0 | 4 |
| Total, all-cause mortality | MK-8628 160 mg | 0 | 2 |
| Total, other adverse events | MK-8628 80 mg | 6 | 6 |
| Total, other adverse events | MK-8628 120 mg | 4 | 4 |
| Total, other adverse events | MK-8628 160 mg | 2 | 2 |
| Total, serious adverse events | MK-8628 80 mg | 1 | 6 |
| Total, serious adverse events | MK-8628 120 mg | 0 | 4 |
| Total, serious adverse events | MK-8628 160 mg | 2 | 2 |
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.
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