Autopsy report · NCT00862134

Randomized, Multi-center, Open-label, Study of PR104 Versus PR104/Docetaxel in Non-Small Cell Lung Cancer (NSCLC)

“Interim analysis indicated low probability of clinically significant result”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 1 year 2 months before it stopped.
• 42 participants enrolled.
• Results were posted on the registry 2 years 8 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

Proacta, Incorporated

Sponsor type

Industry

Conditions

Non-Small Cell Lung Cancer

Interventions

PR104; docetaxel; docetaxel; Granulocyte colony-stimulating factor

Participants

42

Sites

27

Countries

Canada, New Zealand, United States

Trials that died the same way

• 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.” (69% match in meaning)
• A Pilot Study Comparing the Safety and Efficacy of Everolimus With Other Medicines in Recipients of ECD/DCD Kidneys
  “Interim results suggested a concern for patient outcomes and safety” (69% match in meaning)
• A Study to Assess the Anti-fatigability Effect of CK-2127107 in Elderly Male and Female Subjects With Limitations in Mobility
  “Lack of efficacy determined at interim analysis” (67% match in meaning)
• Vorinostat Plus FND in Relapsed or Refractory Mantle Cell Lymphoma
  “we collected data of a total of 19 patients for an interim analysis. but there are less than 7 responses out of the initial 19 patients.” (66% match in meaning)
• In-exsufflator Cough Assist Device in Patients With Symptomatic Bronchiectasis
  “interim analysis indicates statistical futility for primary outcomes” (65% 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.