Clinical trial · Interventional
A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Phase 1b Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
NCT03484520CI-TRIAL-00062961terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategic considerations
Summary
Brief summary (as posted)
An open-label, dose-escalation study to assess safety, pharmacokinetics and efficacy as well as determine the recommended Phase 2 doses of co-administered therapy of dinaciclib and venetoclax for patients with relapsed or refractory Acute Myeloid Leukemia (R/R AML).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer - Acute Myeloid Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dinaciclib | Drug | Dinaciclib | ALIAS |
| Venetoclax | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Venetoclax + Dinaciclib
- description
- Venetoclax and dinaciclib will be administered in combination. Different combinations of dose levels for venetoclax and dinaciclib will be explored.
- interventionNames
- Drug: Venetoclax
- Drug: Dinaciclib
Primary outcomes (10)
- measure
- Tmax of Venetoclax
- timeFrame
- Approximately 29 days after first dose of study drug
- description
- Time to maximum plasma concentration (Tmax) of venetoclax.
- measure
- Recommended Phase 2 Dose (RPTD) of co-administered Dinaciclib and Venetoclax
- timeFrame
- Minimum first cycle of dosing (21 days)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of acute myeloid leukemia (AML) by World Health Organization criteria excluding acute promyelocytic leukemia (APL)-M3. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. * Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol. Exclusion Criteria: * Known central nervous system leukemia * Severe chronic obstructive pulmonary disease (COPD) with hypoxemia * History of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment. * Prior allogeneic stem cell transplant within 6 months of study drug administration and no requirement for graft versus host therapy. * History of clinically significant medical condition that, in the opinion of the investigator, would adversely affect participation in this study. * Known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. * History of tumor lysis syndrome (TLS) due to previous exposure to venetoclax.
References
Publications (0)
Data not yet available
No reference posted for this study.