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A Phase 1/2 Study of Venetoclax in Combination with Low-Dose Cytarabine in Treatment-Naïve Subjects with Acute Myelogenous Leukemia Who Are ≥ 60 Years of Age and Who Are Not Eligible for Standard Anth...

Mise à jour : Il y a 4 ans
Référence : EUCTR2014-002610-23

A Phase 1/2 Study of Venetoclax in Combination with Low-Dose Cytarabine in Treatment-Naïve Subjects with Acute Myelogenous Leukemia Who Are ≥ 60 Years of Age and Who Are Not Eligible for Standard Anthracycline-Based Induction Therapy

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Extrait

● The primary objectives of the Phase 1 portion are to assess the safety profile, characterize pharmacokinetics (PK), determine the dose schedule, the maximum tolerated dose (MTD), and the recommended Phase 2 dose (RPTD) of venetoclax (ABT-199/GDC-0199) in combination with LDC in treatment-naïve subjects with AML who are ≥ 65 years of age and who are not eligible for standard induction therapy due to co-morbidity or other factors. ● The primary objective of the initial Phase 2 portion of the study is to evaluate the leukemia response rate and duration and characterize the toxicities of the combination at the Recommended Phase 2 Dose (RPTD). ● The primary objective of Phase 2 Cohort C is to evaluate the ORR for subjects allowed additional supportive medications (strong CYP3A inhibitors) if medically indicated.

Critère d'inclusion

  • Acute myelogenous leukemia

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