Trial · NCT03772925
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended Phase 2 Dose (RP2D) for the Combination of MLN4924 (Pevonedistat) and Belinostat | Up to the end of cycle 1, 21 days. | Determined by the number of patients with treatment dosing level toxicities (DLT's). DLT's will be defined in cycle 1 as pre-specified adverse events that are considered by the investigator to be related to therapy with MLN4924 (pevonedistat) and/or belinostat. |
| 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. | Number of graded Adverse Events (AEs) reported using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. |
| Secondary | Treatment Response | From day 1 until final response measured, up to 188 days. | The percentage of participants that experience a decrease in tumor size (partial response), or disappearance of tumor (complete response), classified according to International Working Group (IWG) and European Leukemia Net (ELN) criteria for response assessment in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). |
| Secondary | Duration of Stable and Complete Response | From documentation of tumor response to disease progression or death assessed up to 188 days. | Number of days patients remained in stable or complete response. |
| Secondary | Time to Response | From Day 1 of protocol treatment to the time of documentation of tumor response, assessed up to 188 days. | Number of days from day 1 of therapy to best response. |
| Secondary | Change in MLN4924 Belinostat Plasma Concentrations | Baseline up to cycle 1 day 1 | Pharmacokinetic parameters in MLN4924 belinostat will be calculated using standard non-compartmental methods and summarized as geometric mean and geometric coefficient of variation. |
| Secondary | Change in MLN4924 Pevonedistat Plasma Concentrations | Baseline up to cycle 1 day 1 | Pharmacokinetic (PK) parameters in MLN4924 pevonedistat will be calculated using standard non-compartmental methods and summarized as geometric mean and geometric coefficient of variation. |
| Secondary | Change in MLN4924 Belinostat Glucuronide Plasma Concentrations | Baseline up to cycle 1 day 1 | Pharmacokinetic parameters in MLN4924 belinostat glucuronide will be calculated using standard non-compartmental methods and summarized as geometric mean and geometric coefficient of variation. |
| Other | Determine What Relationship, if Any, Exists Between Such Responses and TP53/FLT3 Mutational Status. | Screening | TP53 and FLT3 mutational status by NGS compared to best clinical response classified according to International Working Group (IWG) and European Leukemia Net (ELN) criteria for response assessment in AML and MDS using a specific hematologic and blast count thresholds to define outcomes like Complete Remission (CR) or Hematologic Improvement (HI), focusing on blood counts (Hb, ANC, Platelets) and bone marrow (BM) blasts, with recent updates (IWG 2023/2024) emphasizing clearer definitions, limited recovery categories (CRi, CRL), and incorporating transfusion dependency/independence for better clinical relevance. Scoring isn't a single number but categorizing responses (CR, CRi, HI, Failure). |
| Other | 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 | Paired t-tests will be used to determine if there is a significant change in each of the candidate biomarker between the pre- and 24-hour post-treatment assessments, in bone marrow samples and/or blood samples. |
| Other | 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 | Paired t-tests will be used to determine if there is a significant change in each of the candidate biomarker between the pre- and 24-hour post-treatment assessments, in bone marrow samples and/or blood samples. |
| Other | 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 | Paired t-tests will be used to determine if there is a significant change in each of the candidate biomarker between the pre- and 24-hour post-treatment assessments, in bone marrow samples and/or blood samples. |
| Other | 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 | Paired t-tests will be used to determine if there is a significant change in each of the candidate biomarker between the pre- and 24-hour post-treatment assessments, in bone marrow samples and/or blood samples. |
| Other | 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 | Paired t-tests will be used to determine if there is a significant change in each of the candidate biomarker between the pre- and 24-hour post-treatment assessments, in bone marrow samples and/or blood samples. |
| Other | 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 | Paired t-tests will be used to determine if there is a significant change in each of the candidate biomarker between the pre- and 24-hour post-treatment assessments, in bone marrow samples and/or blood samples. |
| Other | 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 | Paired t-tests will be used to determine if there is a significant change in each of the candidate biomarker between the pre- and 24-hour post-treatment assessments, in bone marrow samples and/or blood samples. |
| Other | 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 | Paired t-tests will be used to determine if there is a significant change in each of the candidate biomarker between the pre- and 24-hour post-treatment assessments, in bone marrow samples and/or blood samples. |
| Other | 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 | Paired t-tests will be used to determine if there is a significant change in each of the candidate biomarker between the pre- and 24-hour post-treatment assessments, in bone marrow samples and/or blood samples. |
| Other | 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 | Paired t-tests will be used to determine if there is a significant change in each of the candidate biomarker between the pre- and 24-hour post-treatment assessments, in bone marrow samples and/or blood samples. |
| Other | 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 | Paired t-tests will be used to determine if there is a significant change in each of the candidate biomarker between the pre- and 24-hour post-treatment assessments, in bone marrow samples and/or blood samples. |
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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