Autopsy report · NCT03656536

A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma

“The study was terminated due to lack of enrollment resulting from a change in the standard of care for the first-line treatment of patients with cholangiocarcinoma. There were no safety concerns that contributed to this decision.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 9 months before it started.
• Ran for about 6 years 1 month before it stopped.
• 167 participants enrolled.
• Results were posted on the registry 1 year 1 month after it ended.

Vital statistics

Status

Terminated

Phase

Phase 3

Sponsor

Incyte Corporation

Sponsor type

Industry

Conditions

Unresectable Cholangiocarcinoma; Metastatic Cholangiocarcinoma

Interventions

Pemigatinib; Gemcitabine; Cisplatin

Participants

167

Sites

215

Countries

Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Japan and more

Trials that died the same way

• Study to Evaluate the Efficacy and Safety of Remdesivir (GS-5734™) Treatment of Coronavirus Disease 2019 (COVID-19) in an Outpatient Setting
  “The study was terminated due to study enrollment feasibility and changing needs of non-hospitalized participants. This decision is not based on efficacy or safety concerns.” (70% match in meaning)
• Surgical Treatment of Chronic Neuropathic Pain
  “The study was terminated due to lower than expected enrollment. The decision to terminate the study was not based on any safety or efficacy concerns.” (70% match in meaning)
• A Study of TCD601 (Siplizumab) in New Onset Type 1 Diabetes Patients
  “The study has been early terminated due to business reasons. This decision is not related to any safety, efficacy, or regulatory concerns.” (69% match in meaning)
• An Evaluation Of PF-03715455 In Moderate To Severe Uncontrolled Asthma
  “The termination was due to business reasons. No safety or efficacy concerns contributed to the termination of the study” (68% match in meaning)
• Treatment Resistance Following Anti-cancer Therapies
  “Study terminated due to lack of enrollment that has been compounded by the global COVID-19 pandemic. There were no safety and/or efficacy concerns involved in the decision to stop enrollment.” (68% 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.