Trials / Recruiting
RecruitingNCT04835584
KRT-232 and TKI Study in Chronic Myeloid Leukemia
An Open-Label, Multicenter, Phase 1b/2 Study of the Safety and Efficacy of KRT-232 Combined With a Tyrosine Kinase Inhibitor (TKI) in Patients With Relapsed or Refractory Ph+ Chronic Myeloid Leukemia (CML)
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 109 (estimated)
- 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, for the treatment of patients with Ph+ Chronic Myeloid Leukemia (CML) who have relapsed or are refractory or intolerant to a Tyrosine Kinase Inhibitor (TKI). This study is a global, open label Phase 1b/2 to determine the efficacy and safety of KRT-232 in patients with chronic phase CML (CML-CP) and accelerated phase (CML-AP) who have failed TKI treatments.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KRT-232 | KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth. |
| DRUG | Dasatinib | Dasatinib is a Tyrosine Kinase Inhibitor anticancer drug taken by mouth. |
| DRUG | Nilotinib | Nilotinib is an Tyrosine Kinase Inhibitor anticancer drug taken by mouth. |
Timeline
- Start date
- 2021-05-07
- Primary completion
- 2024-12-31
- Completion
- 2026-06-30
- First posted
- 2021-04-08
- Last updated
- 2022-03-21
Locations
26 sites across 8 countries: United States, Canada, France, Italy, Poland, Russia, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04835584. Inclusion in this directory is not an endorsement.