Autopsy report · NCT03295396

ONC201 in Adults With Recurrent H3 K27M-mutant Glioma

“The Sponsor terminated the study to prioritize enrollment in a randomized Phase 3 trial of ONC201 in an earlier setting. This decision was unrelated to any safety concerns with dordaviprone (ONC201).”

The sponsor’s own words in the registry.

Life of this trial

• Registered 3 months before it started.
• Ran for about 5 years 9 months before it stopped.
• 73 participants enrolled.
• Results were posted on the registry 2 years after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

Jazz Pharmaceuticals

Sponsor type

Industry

Conditions

Glioma

Interventions

Dordaviprone (ONC201)

Participants

73

Sites

9

Countries

United States

Trials that died the same way

• Reparixin in COVID-19 Pneumonia - Efficacy and Safety
  “The sponsor has decided to start with a separate protocol for phase 3 and therefore this study was terminated with only phase 2.” (65% match in meaning)
• A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Low Back Pain
  “Based on lack of efficacy in PAI2003, sponsor made the decision to discontinue the trial.” (64% match in meaning)
• Common Safety Follow-up Trial of Tecemotide (L-BLP25)
  “The study is terminated prematurely as the sponsor decided to discontinue program with Tecemotide in NSCLC.” (63% match in meaning)
• An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity
  “The study was terminated early due to sponsor decision unrelated to safety or efficacy findings” (63% match in meaning)
• PROPEL - A Prospective Observational Patient Registry to Evaluate ENPP1 and ABCC6 Deficiency
  “The study was terminated by the sponsor prior to planned completion based on a review of the data across indications and overall program considerations. Study termination was not related to participant safety.” (63% 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.