A Dose-finding Study of CC-90009 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

Official Title

A Phase 1, Open-label, Dose Finding Study of CC-90009 in Subjects With Relapsed, Refractory Acute Myeloid Leukemia

Summary:

CC-90009-AML-001 is a phase 1, open-label, dose escalation and expansion, study in subjects with relapsed or refractory acute myeloid leukemia

Trial Description

Primary Outcome:

  • Dose- limiting toxicity (DLT)
  • Non-tolerated dose (NTD)
  • Maximum tolerated dose (MTD)
Secondary Outcome:
  • Pharmacokinetics-Cmax
  • Pharmacokinetics - AUC
  • Pharmacokinetics - tmax
  • Pharmacokinetics - t 1/2
  • Pharmacokinetics - CL
  • Pharmacokinetics - Vmax
  • Preliminary efficacy of CC-90009
Study CC-90009-AML-001 is an open-label, Phase 1, dose escalation and expansion, first-in-human clinical study of CC-90009 in subjects with relapsed or refractory acute myeloid leukemia (AML).

The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-90009, The expansion part (Part B) will further evaluate the safety and efficacy of CC-90009 administered at or below the maximum tolerated dose (MTD) in selected expansion cohorts of in order to determine the recommended Phase 2 dose (RP2D).

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