Trials / Terminated
TerminatedNCT02545283
A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase III Study of Idasanutlin, an MDM2 Antagonist, With Cytarabine Versus Cytarabine Plus Placebo in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 447 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cytarabine | Participants will receive cytarabine 1 gram per square meter (g/m\^2) intravenous (IV) infusion for 5 days of every treatment cycle. |
| DRUG | Idasanutlin | Participants will receive idasanutlin 300 mg per oral (PO) twice daily (BID) (in Cycle 1) or once daily (QD) (in Cycles 2 and 3) for 5 days of every treatment cycle. |
| OTHER | Placebo | Participants will receive idasanutlin matching placebo PO BID or QD for 5 days of every treatment cycle. |
Timeline
- Start date
- 2015-12-30
- Primary completion
- 2020-04-24
- Completion
- 2020-04-24
- First posted
- 2015-09-09
- Last updated
- 2022-01-11
- Results posted
- 2021-09-14
Locations
82 sites across 19 countries: United States, Australia, Austria, Belgium, Canada, Finland, France, Germany, Israel, Italy, Netherlands, New Zealand, Norway, Panama, Russia, South Korea, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02545283. Inclusion in this directory is not an endorsement.