drugset / Trial / NCT02909972
Safety Study of ALRN-6924 in Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Phase 1/1b, open label, multi-center dose escalation and dose expansion study designed to evaluate safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics) and anti-tumor effects of ALRN-6924 alone or in combination with cytarabine in patients with relapsed/refractory acute myeloid leukemia or advanced myelodysplastic syndrome with wild-type (WT) TP53
Timeline
- Start
- 2016-09
- Primary completion
- 2019-04
- Completion
- 2019-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 200 mg/m2 | Intravenous |
| Subject | SULANEMADLIN | Peptide | — | Intravenous |