Autopsy report · NCT00838578

Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer

“Per protocol, the study was terminated based on interim analysis results”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 month before it started.
• Ran for about 3 years 7 months before it stopped.
• 65 participants enrolled.
• Results were posted on the registry 2 years 5 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 1, Phase 2

Sponsor

Kyowa Kirin Co., Ltd.

Sponsor type

Industry

Conditions

Colorectal Cancer

Interventions

KRN330; Irinotecan

Participants

65

Sites

12

Countries

United States

Trials that died the same way

• Effect of Enzymes on Dental Biofilm Accumulation in Healthy Individuals
  “The study was terminated after interim data analysis” (84% match in meaning)
• Cardioneuroablation: Comparison of Right Versus Left Atrial Approach in Patients With Reflex Syncope
  “Significant differences between the groups were noted during interim analysis (as scheduled in the protocol) and the study was stopped because the final result was obtained” (81% match in meaning)
• A Study to Evaluate the Efficacy and Safety of Piracetam on Aphasia After Acute Ischemic Cerebral Artery Stroke
  “This study was terminated after a pre-specified interim analysis. Please see Detailed Study Description for further information.” (80% match in meaning)
• LBH589 in Refractory Myelodysplastic Syndromes (MDS)
  “Per protocol, the results of a planned interim analysis demonstrated insufficient efficacy and led to early termination of the study.” (77% match in meaning)
• Irrisept Versus Standard of Care in the Prevention of Surgical Site Infections
  “The study was terminated early after the Interim Analysis due, in part, to issues with the accuracy and completeness of the data collected.” (76% 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.