A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies

Official Title

A Phase 1 Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies

Summary:

An open-label, global, multi-centre study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.

Trial Description

Primary Outcome:

  • AUC0-24 post-dose of venetoclax
  • Recommended Phase 2 dose (RPTD) of venetoclax
  • Number of Participants with Dose limiting toxicities (DLT) of Venetoclax Monotherapy
  • Tmax of venetoclax
  • Cmax of venetoclax
Secondary Outcome:
  • Objective Response Rate (ORR)
  • Partial Response (PR) rate
  • Complete Response (CR) rate

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