A Study of Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients Aged >/= 60 Years With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy

Official Title

A Phase IB/II Multi-Arm Study With Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients Aged >/= 60 Years With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy

Summary:

The primary objective for this study is to assess the safety and tolerability as well as preliminary efficacy of venetoclax in combination with cobimetinib, and venetoclax in combination with idasanutlin in patients >/= 60 years of age with relapsed or refractory acute myeloid leukemia (R/R) AML who are not eligible for cytotoxic therapy.

Trial Description

Primary Outcome:

  • Phase Ib: Number of Participants with Dose Limiting Toxicities (DLTs)
  • Phase Ib: Number of Participants with Adverse Events, Including Adverse Events of Special Interest and Serious Adverse Events
  • Phase Ib: Number of Participants with Clinically Significant Changes in Safety Measurements, Including Vital Signs, Physical Exam Findings, Electrocardiograms (ECGs) and Clinical Laboratory
  • Phase Ib: Mortality Rates, Including Thirty and Sixty Day
  • Phase II: Percentage of Participants with Complete Remission (CR)
  • Phase II: Percentage of Participants with Complete Remission with Incomplete Blood Count Recovery (CRi)
  • Phase II: Percentage of Participants with Complete Remission with Incomplete Platelet Count Recovery (CRp)
Secondary Outcome:
  • Overall Response Rate (ORR) (CR + CRi + CRp + Partial Remission/Partial Response [PR])
  • Duration of Response (DOR)
  • Time to Progression (TTP)
  • Progression-Free Survival (PFS)
  • Event-Free Survival (EFS)
  • Leukemia-Free Survival (LFS)
  • Overall Survival (OS)
  • Pharmacokinetics of Venetoclax Area Under the Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t)
  • Pharmacokinetics of Venetoclax Maximum Observed Concentration (Cmax)
  • Pharmacokinetics of Cobimetinib Area Under the Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t)
  • Pharmacokinetics of Cobimetinib Maximum Observed Concentration (Cmax)
  • Pharmacokinetics of Cobimetinib Oral Apparent Clearance (CL/F)
  • Pharmacokinetics of Idasanutlin Oral Apparent Clearance (CL/F)
  • Pharmacokinetics of Idasanutlin Apparent Volume of Distribution (V/F)
  • Pharmacokinetics of Idasanutlin Maximum Observed Concentration (Cmax)
  • Pharmacokinetics of Idasanutlin Steady-State Concentration (Ctrough)
  • Pharmacokinetics of Idasanutlin Area Under the Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t)
  • Pharmacokinetics of Idasanutlin Area Under the Concentration-Time Curve from Time Zero to 24 Hours (AUC24h)
  • Pharmacokinetics of Idasanutlin Terminal Elimination Half-Life (t1/2)
  • Number of Patients Reporting Symptoms in Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Questionnaire

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society