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NCT04113616 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study, sponsored by Kartos Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
NCT04113616: Clinical Trial Phase 1 study, sponsored by Kartos Therapeutics.
NCT04113616 is a Phase 1 study that was terminated before completion, run by Kartos Therapeutics. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04113616, a Phase 1 study, was terminated before completion, sponsored by Kartos Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
Study 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).
Primary Outcome
Number of dose-limiting toxicities (DLTs) of KRT-232 in combination with cytarabine or decitabine
Interventions
- DRUG Decitabine
- DRUG Cytarabine
- DRUG KRT-232
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2019-09-25 |
| Est. Completion | 2023-09-27 |
| Phase | Phase 1 |
Why NCT04113616 stopped before completion
NCT04113616 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 3 interventions - of which Decitabine is the first listed.
NCT04113616 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04113616 about?
NCT04113616 is a clinical study titled "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)". 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 mu...
What is the current status of trial NCT04113616?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2019-09-25. Estimated completion is 2023-09-27.
What interventions are being tested in trial NCT04113616?
The interventions under investigation include: Decitabine (DRUG), Cytarabine (DRUG), KRT-232 (DRUG).
Who is sponsoring clinical trial NCT04113616?
This trial is sponsored by Kartos Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04113616's enrollment target sits among peer trials
70 749th of 2000 higher than 1,227 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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