Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02545283 · ClinicalTrials.gov registry record · Phase 3
A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 447
- Enrollment target
NCT02545283 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 447 participants.
The verdict
NCT02545283, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 447 participants
- Enrollment target
Study Summary
This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare overall survival in participants with relapsed or refractory AML treated with idasanutlin in combination with cytarabine versus participants treated with placebo and cytarabine. Participants will receive induction treatment with idasanutlin/placebo and cytarabine (Cycle 1). Responding participants may continue to receive a maximum of further two cycles of consolidation (Cycle 2 and Cycle 3). Complete remission (CR), CR with incomplete platelet count recovery (CRp), overall remission rate (ORR), event-free survival (EFS) and percentage of participants with an allogeneic hematopoietic stem cell transplant (HSCT) will also be compared between treatment arms. This study will include participants with and without TP53 wild type (TP53 WT) mutations.
Interventions
- OTHER Placebo
- DRUG Cytarabine
- DRUG Idasanutlin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 447 participants |
| Start Date | 2015-12-30 |
| Est. Completion | 2020-04-24 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02545283
The ClinicalTrials.gov registry entry for NCT02545283 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 447 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 3 interventions - of which Placebo is the first listed.
NCT02545283 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02545283 about?
NCT02545283 is a clinical study titled "A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)". This is a multicenter, double-blind, randomized, placebo-controlled study designed to compare overall survival in participants with relapsed or refractory AML treated with idasanutlin in combination with cytarabine versus participants treated with placebo and cytarabine. Participants will receive in...
What is the current status of trial NCT02545283?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 447 participants. The study started on 2015-12-30. Estimated completion is 2020-04-24.
What interventions are being tested in trial NCT02545283?
The interventions under investigation include: Placebo (OTHER), Cytarabine (DRUG), Idasanutlin (DRUG).
Who is sponsoring clinical trial NCT02545283?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.