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

Official Title

A Phase 1, Open-label, Dose-Finding Study of CC-90009, a Novel Cereblon E3 Ligase Modulating Drug, in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes

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 and relapsed or refractory high-risk myelodysplastic syndrome.

Trial Description

Primary Outcome:

  • Dose- limiting toxicity (DLT)
  • Non-tolerated dose (NTD)
  • Maximum tolerated dose (MTD)
Secondary Outcome:
  • Pharmacokinetics-Cmax
  • Pharmacokinetics - AUC24
  • Pharmacokinetics - tmax
  • Pharmacokinetics - t 1/2
  • Pharmacokinetics - CL
  • Pharmacokinetics - Vss
  • Preliminary efficacy of CC-90009
  • Preliminary efficacy of CC-90009 - AML
  • Preliminary efficacy of CC-90009 - MDS
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) and relapsed or refractory high-risk myelodysplastic syndrome. The dose escalation part (Part A) of the study will evaluate the safety and tolerability of escalating doses of CC-90009 in relapsed and refractory AML. 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 one or more dosing regimens in order to determine the recommended Phase 2 dose (RP2D) for subjects with relapsed or refractory AML and relapsed or refractory high-risk myelodysplastic syndrome.

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