Trials / Terminated
TerminatedNCT04113616
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)
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Kartos Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Relapsed or Refractory Acute Myeloid Leukemia (AML)
- Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KRT-232 | KRT-232 is an experimental MDM2 inhibitor anti-cancer drug taken by mouth. |
| DRUG | Cytarabine | Cytarabine is an anti-cancer chemotherapy drug taken via injection. |
| DRUG | Decitabine | Decitabine is an anti-cancer chemotherapy drug taken via injection. |
Timeline
- Start date
- 2019-09-25
- Primary completion
- 2023-09-27
- Completion
- 2023-09-27
- First posted
- 2019-10-03
- Last updated
- 2024-03-22
Locations
59 sites across 12 countries: United States, Australia, Belgium, France, Germany, Hungary, Israel, Italy, Poland, South Korea, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04113616. Inclusion in this directory is not an endorsement.