At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 51 enrolled
Drug / intervention
APR-246 +2 moredrug
Likely dose
APR-246 4.5 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I Study of APR-246 in Combination With Venetoclax and Azacitidine in TP53-Mutant Myeloid Malignancies
In Brief
A Phase 1 clinical trial evaluating APR-246, Venetoclax, and 1 other intervention for Myeloid Malignancy. Completed, enrolled 51 participants across 8 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyeloid Malignancy
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2020202120222023202420252026
Enrollment StartDec 2019
First PostedJan 2020
Primary CompletionJan 2022
TodayJul 2026
First PostedJan 2, 2020
Enrollment StartDec 13, 2019
Primary CompletionJan 14, 2022
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 6.5 years ago
Interventions
APR-246drug
APR-246 4.5 g/day
Venetoclaxdrug
Venetoclax 400 mg once daily
Azacitidinedrug
Subcutaneous injection, or intravenous infusion