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A Study of Venetoclax and Dinaciclib (MK7965) in Patients With Relapsed/Refractory Acute Myeloid Leukemia

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AbbVie

Status and phase

Terminated
Phase 1

Conditions

Cancer - Acute Myeloid Leukemia

Treatments

Drug: Dinaciclib
Drug: Venetoclax

Study type

Interventional

Funder types

Industry

Identifiers

NCT03484520
M16-183
2017-003213-26 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

48 participants in 1 patient group

Venetoclax + Dinaciclib
Experimental group
Description:
Venetoclax and dinaciclib will be administered in combination. Different combinations of dose levels for venetoclax and dinaciclib will be explored.
Treatment:
Drug: Venetoclax
Drug: Dinaciclib

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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