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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 is a Phase 1 study that was terminated before completion, run by Kartos Therapeutics. The registered enrollment target is 70 participants.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04113616
The ClinicalTrials.gov registry entry for NCT04113616 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kartos Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Decitabine is the first listed.
NCT04113616 reports 0 study locations.
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.
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