drugset / Trial / NCT04113616
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 When Administered Alone and in Combination With Low-Dose Cytarabine (LDAC) or Decitabine in Patients With Acute Myeloid Leukemia (AML)
RandomizedParallel-groupOpen-labelTreatment
Summary
This study evaluates KRT-232, a novel oral small molecule inhibitor of MDM2, when administered alone and in combination with low-dose cytarabine (LDAC) or Decitabine for the treatment of adults with Acute Myeloid Leukemia (AML) and AML secondary to myeloproliferative neoplasms (MPN). Participants must be relapsed/refractory (having failed prior therapy) and will be assigned to receive monotherapy (KRT-232 alone) or combination therapy (KRT-232 with LDAC or KRT-232 with Decitabine).
Timeline
- Start
- 2019-09-25
- Primary completion
- 2023-09-27
- Completion
- 2023-09-27
Outcome
Outcome not reported
Stopped (Business): “In September 2023, the study was terminated because of a Sponsor decision, unrelated to safety concerns.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 20 mg/m2 | Subcutaneous |
| Subject | Decitabine | Small molecule | 20 mg/m2 | Intravenous |
| Subject | Navtemadlin | Small molecule | 180 mg | Oral |
| Subject | Navtemadlin | Small molecule | 240 mg | Oral |
| Subject | Navtemadlin | Small molecule | 360 mg | Oral |