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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: Clinical Trial Phase 1 study, sponsored by Hoffmann-La Roche.
NCT03850535 is a Phase 1 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Sponsor's decision to prematurely terminate the study was made at the end of the Phase 1. The planned Phase 2 was not initiated. This decision was not based on safety concerns, but rather due to the overall company strategy about the adult 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 |
Why NCT03850535 stopped before completion
NCT03850535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 4 interventions - of which Cytarabine is the first listed.
NCT03850535 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03850535's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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