Trial · NCT03772925
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Recommended Phase 2 Dose (RP2D) for the Combination of MLN4924 (Pevonedistat) and Belinostat | Up to the end of cycle 1, 21 days. | 2 patients in dose level 5 did not complete treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Adverse Events (AEs) | Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months. | Adverse Events Reported | NUMBER | |
| SECONDARY | Treatment Response | From day 1 until final response measured, up to 188 days. | 4 participants not assessed. (1 patient receiving dose level 1, 3 receiving dose level 4) These patients stopped treatment too early to assess response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Stable and Complete Response | From documentation of tumor response to disease progression or death assessed up to 188 days. | 5 participants that had either complete response or stable disease were measured. | Days | MEAN |
| SECONDARY | Time to Response | From Day 1 of protocol treatment to the time of documentation of tumor response, assessed up to 188 days. | 4 participants not assessed (1 receiving dose level 1, 3 receiving dose level 4 due to stopping treatment too early to measure response.) | Days | MEAN |
| SECONDARY | Change in MLN4924 Belinostat Plasma Concentrations | Baseline up to cycle 1 day 1 | 2 participants receiving dose level 5 had insufficient blast% to analyze the sample, per the protocol | ng/ml | MEAN |
| SECONDARY | Change in MLN4924 Pevonedistat Plasma Concentrations | Baseline up to cycle 1 day 1 | Change in MLN4924 pevonedistat plasma concentrations specimens were drawn, but were not analyzed at dose level #5 because the PK studies were done by the pharmaceutical sponsor (Takeda). As Takeda had decided to terminate the trial, they elected not to complete the pevonedistat PK analysis at dose level #5. The samples will not be analyzed in the future. | ng/ml | MEAN |
| SECONDARY | Change in MLN4924 Belinostat Glucuronide Plasma Concentrations | Baseline up to cycle 1 day 1 | ng/ml | MEAN | |
| OTHER_PRE_SPECIFIED | Determine What Relationship, if Any, Exists Between Such Responses and TP53/FLT3 Mutational Status. | Screening | |||
| OTHER_PRE_SPECIFIED | Change in Candidate Biomarker Levels in Bone Marrow and/or Blood Samples gH2A.X | Baseline up to 24 hours post-treatment with the first doses of study drugs | |||
| OTHER_PRE_SPECIFIED | Change in Candidate Biomarker Levels in Bone Marrow and/or Blood Samples Phosphorylated Checkpoint Kinase 1 (p-Chk1) | Baseline up to 24 hours post-treatment with the first doses of study drugs | |||
| OTHER_PRE_SPECIFIED | Change in Candidate Biomarker Levels in Bone Marrow and/or Blood Samples Phosphorylated FANCD2 (p-FANCD2) | Baseline up to 24 hours post-treatment with the first doses of study drugs | |||
| OTHER_PRE_SPECIFIED | Change in Candidate Biomarker Levels in Bone Marrow and/or Blood Samples Myeloid Cell Leukemia Sequence 1 (MCL-1) | Baseline up to 24 hours post-treatment with the first doses of study drugs | |||
| OTHER_PRE_SPECIFIED | Change in Candidate Biomarker Levels in Bone Marrow and/or Blood Samples Protein BCL-xL | Baseline up to 24 hours post-treatment with the first doses of study drugs | |||
| OTHER_PRE_SPECIFIED | Change in Candidate Biomarker Levels in Bone Marrow and/or Blood Samples Anti-apoptotic Protein BCL-2 | Baseline up to 24 hours post-treatment with the first doses of study drugs | |||
| OTHER_PRE_SPECIFIED | Change in Candidate Biomarker Levels in Bone Marrow and/or Blood Samples p-Wee1 Kinase | Baseline up to 24 hours post-treatment with the first doses of study drugs | |||
| OTHER_PRE_SPECIFIED | Change in Candidate Biomarker Levels in Bone Marrow and/or Blood Samples Histone H4 Acetylation at Lysine 16 | Baseline up to 24 hours post-treatment with the first doses of study drugs | |||
| OTHER_PRE_SPECIFIED | Change in Candidate Biomarker Levels in Bone Marrow and/or Blood Samples Bcl-2 Interacting Mediator of Cell Death (BIM) | Baseline up to 24 hours post-treatment with the first doses of study drugs | |||
| OTHER_PRE_SPECIFIED | Change in Candidate Biomarker Levels in Bone Marrow and/or Blood Samples Chromatin Licensing and DNA Replication Factor 1 (Cdt-1) | Baseline up to 24 hours post-treatment with the first doses of study drugs | |||
| OTHER_PRE_SPECIFIED | Change in Candidate Biomarker Levels in Bone Marrow and/or Blood Samples C-terminal Binding Protein Interacting Protein (CtlP) | Baseline up to 24 hours post-treatment with the first doses of study drugs |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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GET https://conductscience.org/api/trials/v1/NCT03772925/outcomes