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NCT03850535 · ClinicalTrials.gov registry record · Phase 1
A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03850535 is a Phase 1 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 24 participants.
The verdict
NCT03850535, a Phase 1 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin when it is given in combination with cytarabine and daunorubicin in induction, in combination with cytarabine in consolidation, and as a single agent in maintenance for treating participants with acute myeloid leukemia (AML).
Interventions
- DRUG Cytarabine
- DRUG Daunorubicin
- DRUG Idasanutlin
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-03-25 |
| Est. Completion | 2020-09-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03850535
The ClinicalTrials.gov registry entry for NCT03850535 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cytarabine is the first listed.
NCT03850535 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03850535 about?
NCT03850535 is a clinical study titled "A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin in Patients Newly Diagnosed With Acute Myeloid Leukemia (AML) and the Safety and Efficacy of Idasanutlin in the Maintenance of First AML Complete Remission". This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin when it is given in combination with cytarabine and daunorubicin in induction, in combination with cytarabine in consolidation, and as a single agent in maintenance...
What is the current status of trial NCT03850535?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2019-03-25. Estimated completion is 2020-09-10.
What interventions are being tested in trial NCT03850535?
The interventions under investigation include: Cytarabine (DRUG), Daunorubicin (DRUG), Idasanutlin (DRUG), Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT) (PROCEDURE).
Who is sponsoring clinical trial NCT03850535?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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