Spots Global Cancer Trial Database for APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies

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Trial Identification

Brief Title: APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies

Official Title: Phase I Study of APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies

Study ID: NCT04214860

Conditions

Myeloid Malignancy

Interventions

APR-246

Venetoclax

Azacitidine

Study Description

Brief Summary: This clinical trial is a Phase I, open-label, dose-finding and cohort expansion study to determine the safety and preliminary efficacy of APR-246 in combination with venetoclax and azacitidine in patients with myeloid malignancies.

Detailed Description: This study will enroll adult male and female patients of age ≥ 18 years with documented diagnosis of AML, according to WHO classification, and documented TP53 mutation which is not benign or likely benign, who also meet the eligibility requirements of this protocol. The study will include a safety lead-in dose-finding portion followed by expansion portion. During the safety lead-in portion of the study, two cohorts will independently enroll patients following a 3 + 3 design. Each cohort will enroll up to 6 patients. The expansion portion will begin once the recommended phase II dose (RP2D) of APR-246 in combination with venetoclax and in combination with venetoclax and azacitidine have been determined in order to assess the antitumor activity of these combinations.