A Safety and Efficacy Study of Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 Plus Subcutaneous Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML)

Official Title

A Phase 1b/2 Open-label, Randomized Study of 2 Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine: Oral AG-120 Plus Subcutaneous Azacitidine and Oral AG-221 Plus SC Azacitidine in Subjects With Newly Diagnosed Acute Myeloid Leukemia Harboring an IDH1 or an IDH2 Mutation, Respectively, Who Are Not Candidates to Receive Intensive Induction Chemotherapy

Summary:

This Phase 1b/2 study is an open-label, randomized, multicentre trial to evaluate the safety and efficacy of oral AG-120 + Subcutaneous (SC) azacitidine and oral AG-221 + SC azacitidine in subjects with newly diagnosed AML with an IDH1 or an IDH2 mutation, respectively. The study population consists of subjects who are not candidates to receive intensive Inductive chemotherapy (IC). The study comprises a Phase 1b dose-finding and AG-120 expansion stage and a Phase 2 randomized stage.

Trial Description

Primary Outcome:

  • Dose limiting toxicities (DLTs)-Phase 1B
  • Adverse Events (AEs) in Ph 1b
  • Pharmacokinetics- Cmax
  • Pharmacokinetics- Tmax
  • Pharmacokinetics- AUC
  • Overall response rate (ORR) Ph 2
Secondary Outcome:
  • Overall Response Rate - Phase 1b (Ph 1b)
  • Event-Free Survival - Phase 2 (Ph 2)
  • Adverse Events (AEs) - Ph 2
  • Complete remission rate - Ph 2
  • Hematologic improvement rate - Ph 2
  • Duration of Response - Ph 2
  • Overall Survival - Ph 2
  • One-year survival- Ph 2
  • Pharmacokinetics- Cmax - Ph 2
  • Pharmacokinetics- Tmax - Ph 2
  • Pharmacokinetics- AUC - Ph 2
  • EORTC QLQ-C30 - European Organization for Research and Treatment of Cancer Quality-of-Life questionnaire - Ph 2
  • EQ-5D-5L Health Questionnaire - Ph 2
  • Overall Response Rate - Phase 1b (Ph 2)
  • Time to Response - Phase 2
The study was redesigned to expand the number of patients analyzed during the Phase 1b stage of the study to determine a safe and effective dose of AG-120 administered with azacitidine for future studies. The Phase 1b (AG-120 expansion) stage will evaluate the safety, tolerability, and clinical activity of oral AG-120 when administered with Subcutaneous azacitidine. The Phase 2 stage of the study will no longer include AG-120 administered with azacitidine (IDH1 subjects) and IDH1 patients will not longer be included in the azacitidine alone arm.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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