Clinical Trials /

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

NCT03484520

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).

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

DrugSynonymsArms
VenetoclaxABT-199, GDC-0199Venetoclax + Dinaciclib
DinaciclibMK-7965, SCH-727965Venetoclax + 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

NameTypeDescriptionInterventions
Venetoclax + DinaciclibExperimentalVenetoclax and dinaciclib will be administered in combination. Different combinations of dose levels for venetoclax and dinaciclib will be explored.
  • Venetoclax
  • Dinaciclib

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:Recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Cancer
  • Acute Myeloid Leukemia (AML)
  • venetoclax
  • dinaciclib
  • Relapsed/refractory AML
  • Pharmacokinetics

Last Updated

November 18, 2019