Trials / Completed
CompletedNCT03072043
Phase 1b/2 Safety and Efficacy of APR-246 w/Azacitidine for tx of TP53 Mutant Myeloid Neoplasms
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Participants will be treated for a total of 6 cycles. For participants responding or who have stable disease following cycle 6, treatment may continue until one of the following criteria applies: * Inter-current illness that prevents further administration of treatment, * Unacceptable adverse event(s), * Participant decides to withdraw from the study, or * General or specific changes in the participant's condition render the participant unacceptable for further treatment in the judgment of the investigator. * Evidence of disease progression by the International Working Group (IWG) 2006 criteria. Participants who wish not to continue treatment at time of disease assessment at end of cycle 6 will complete their end of treatment visit upon completion of cycle 6.
Conditions
- Myelodysplastic Syndrome
- Acute Myeloid Leukemia
- Myeloproliferative Neoplasm
- Chronic Myelomonocytic Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | APR-246 | 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). |
| DRUG | Azacitidine | Azacitidine is administered subcutaneously (SC) or via IV at 75 mg/m\^2. |
Timeline
- Start date
- 2017-05-18
- Primary completion
- 2019-11-15
- Completion
- 2021-12-08
- First posted
- 2017-03-07
- Last updated
- 2022-01-24
- Results posted
- 2021-02-25
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03072043. Inclusion in this directory is not an endorsement.