Clinical Trials /

A Study of Venetoclax and Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia

NCT03441555

Description:

An open-label, dose-escalation study to assess the safety and pharmacokinetics (PK), to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of alvocidib with venetoclax when co-administered in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML).

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of Venetoclax and Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia
  • Official Title: Phase 1b Study of Venetoclax and Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Clinical Trial IDs

  • ORG STUDY ID: M16-186
  • SECONDARY ID: 2017-002531-42
  • NCT ID: NCT03441555

Conditions

  • Acute Myeloid Leukemia (AML)

Interventions

DrugSynonymsArms
VenetoclaxABT-199Venetoclax + Alvocidib
AlvocidibFlavopiridolVenetoclax + Alvocidib

Purpose

An open-label, dose-escalation study to assess the safety and pharmacokinetics (PK), to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of alvocidib with venetoclax when co-administered in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML).

Trial Arms

NameTypeDescriptionInterventions
Venetoclax + AlvocidibExperimentalVenetoclax administered orally once daily (QD) and Alvocidib administered as an intravenous infusion on Days 1, 2, and 3 for all 28-day treatment cycles. Different combinations of dose levels for venetoclax and alvocidib may be explored.
  • Venetoclax
  • Alvocidib

Eligibility Criteria

        Inclusion Criteria:

          -  Must have adequate coagulation, hematology, kidney, and liver function, per protocol.

          -  Diagnosis of relapsed or refractory (R/R) acute myeloid leukemia (AML)

          -  Meet the following disease activity criteria:

          -  an established, confirmed diagnosis of AML by World Health Organization criteria
             excluding acute promyelocytic leukemia (APL)-M3; and

          -  an Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to
             2.

        Exclusion Criteria:

          -  History of any malignancy within the last 6 months except for those specified in this
             protocol and low-grade malignancies not requiring active treatment such as
             non-melanoma skin cancer, cervical intraepithelial neoplasia, or prostate cancer in
             situ.

          -  Prior allogeneic stem cell transplant within 6 months of study drug administration and
             no requirement for graft versus host therapy.

          -  History of previous enrollment in Studies NCT02993523 or NCT03069352.

          -  History of exposure to alvocidib or any other cyclin-dependent kinase 9 (CDK9)
             inhibitor.
      
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 32 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 8 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:Combined CR Rate
Time Frame:Up to approximately 8 months
Safety Issue:
Description:Combined CR rate 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 based on IWG criteria.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AbbVie

Trial Keywords

  • Cancer
  • Acute Myeloid Leukemia (AML)
  • relapsed Acute Myeloid Leukemia
  • refractory Acute Myeloid Leukemia

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