Autopsy report · NCT02545283

A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)

“The study was stopped for futility based on efficacy results at the interim analysis; no unexpected safety findings were observed.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 4 months before it started.
• Ran for about 4 years 4 months before it stopped.
• 447 participants enrolled.
• Results were posted on the registry 1 year 5 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Hoffmann-La Roche

Sponsor type

Industry

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytarabine; Idasanutlin; Placebo

Participants

447

Sites

82

Countries

Australia, Austria, Belgium, Canada, Finland, France, Germany, Israel, Italy, Netherlands, New Zealand, Norway and more

Trials that died the same way

• Tissue Adhesive vs. Sterile Strips After Cesarean Delivery
  “Based on results of an interim analysis, the study was halted for futility” (87% match in meaning)
• Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease
  “As no safety warnings were detected, Interim analysis from the first 40 patients recommends to stop the trial for futility” (85% match in meaning)
• Trial Investigating the Efficacy and Safety of SCH 900435 (Org 25935) in Relapse Prevention in Participants With Alcohol Dependence (P05718)
  “Based on the outcome of a planned interim analysis, the study was stopped early due to futility.” (85% match in meaning)
• Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)
  “The study was terminated based on the results of a planned interim analysis that showed futility of efficacy.” (83% match in meaning)
• A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
  “The study was terminated by Sponsor as the futility analysis outcome indicated that the study was unlikely to meet the predefined primary objective of the study. No new safety concerns were identified.” (82% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.