At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 55 enrolled
Drug / intervention
APR-246 +1 moredrug
Likely dose
APR-246 50 mg/kgfrom 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.
A Phase 1b/2 Study to Evaluate the Safety and Efficacy of APR-246 in Combination With Azacitidine for the Treatment of TP53 Mutant Myeloid Neoplasms
H. Lee Moffitt Cancer Center and Research Institute·interventional·Posted Mar 7, 2017·Updated Jan 24, 2022
In Brief
A Phase 2 clinical trial evaluating APR-246 and Azacitidine for Myelodysplastic Syndrome and 3 related conditions. Completed, enrolled 55 participants across 6 sites.
Detailed Summary
The main purpose of this study is to determine the safe and recommended dose of APR-246 in combination with azacitidine as well as to see if this combination of therapy improves overall survival.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndrome, Acute Myeloid Leukemia, Myeloproliferative Neoplasm, Chronic Myelomonocytic Leukemia
CountriesUnited States
CollaboratorsAprea Therapeutics
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 2017
Enrollment StartMay 2017
Primary CompletionNov 2019
Study CompletionDec 2021
TodayJul 2026
First PostedMar 7, 2017
Enrollment StartMay 18, 2017
Primary CompletionNov 15, 2019
Study CompletionDec 8, 2021
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.3 years ago
Interventions
APR-246drug
Phase 1b: Dose escalation of APR-246 via intravenous (IV) infusion, with starting dose of 50 mg/kg lean body weight (LBW). Phase 2: APR-246 at maximum tolerated dose (MTD).
Azacitidinedrug
Azacitidine is administered subcutaneously (SC) or via IV at 75 mg/m\^2.