Description:
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).
Title
- Brief Title: A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
- Official Title: Phase 1b Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Clinical Trial IDs
- ORG STUDY ID:
M16-183
- SECONDARY ID:
2017-003213-26
- NCT ID:
NCT03484520
Conditions
- Cancer - Acute Myeloid Leukemia
Interventions
Drug | Synonyms | Arms |
---|
Venetoclax | ABT-199, GDC-0199 | Venetoclax + Dinaciclib |
Dinaciclib | MK-7965, SCH-727965 | Venetoclax + Dinaciclib |
Purpose
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).
Trial Arms
Name | Type | Description | Interventions |
---|
Venetoclax + Dinaciclib | Experimental | Venetoclax and dinaciclib will be administered in combination. Different combinations of dose levels for venetoclax and dinaciclib will be explored. | |
Eligibility Criteria
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Tmax of Venetoclax |
Time Frame: | Approximately 29 days after first dose of study drug |
Safety Issue: | |
Description: | Time to maximum plasma concentration (Tmax) of venetoclax. |
Secondary Outcome Measures
Measure: | Complete Response (CR) Rate |
Time Frame: | Up to approximately 18 months |
Safety Issue: | |
Description: | CR is defined as the proportion of participants with documented complete response (CR) based on International Working Group (IWG) criteria. |
Measure: | Composite CR Rate (CR + CRi) |
Time Frame: | Up to approximately 18 months |
Safety Issue: | |
Description: | Composite is defined as CR + CRi (CR with incomplete blood count recovery) based on IWG criteria. |
Measure: | Objective Response Rate (ORR) |
Time Frame: | Up to approximately 18 months |
Safety Issue: | |
Description: | ORR is defined as the proportion of participants with documented partial response (PR) or better (CR + CRi + partial response [PR]) based on IWG criteria. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | AbbVie |
Trial Keywords
- Cancer, Acute Myeloid Leukemia (AML), venetoclax, dinaciclib, Relapsed/refractory AML, Pharmacokinetics, Venetoclax, Dinaciclib
Last Updated
January 8, 2021