Autopsy report · NCT00447226

Randomized Discontinuation Study of Lapatinib Versus Placebo in Subjects With Documented Tumor Progression After Chemotherapy, or Where no Approved Therapy Exists

“The study had failed to meet the primary objective of tumor response rate at 12 weeks from first dose.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 months before it started.
• Ran for about 2 years 4 months before it stopped.
• 32 participants enrolled.
• Results were posted on the registry 5 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

GlaxoSmithKline

Sponsor type

Industry

Conditions

Cancer

Interventions

Oral lapatinib tablets or placebo tablets

Participants

32

Sites

20

Countries

United States

Trials that died the same way

• A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)
  “The study was early terminated due to lack of efficacy.” (58% match in meaning)
• Evaluation of the Safety, Tolerability and Pharmacokinetics (PK) of GSK3732394 First-Time-in-Human (FTIH) Study
  “The study was terminated early (following completion of SAD Cohort 3; 80 mg) based on PK/PD modelling which demonstrated the medicine's intended target profile was not achievable.” (58% match in meaning)
• Efficacy and Safety of SYNB1934 in Patients With PKU (SYNPHENY-3)
  “Based on a review of interim data from participants in the dose-escalation phase, it was determined that the study was unlikely to meet the primary endpoint.” (58% match in meaning)
• Nab-Sirolimus and Pazopanib Hydrochloride in Treating Patients With Advanced Nonadipocytic Soft Tissue Sarcomas
  “Study was terminated at completion of the Phase 1 dose escalation due to loss of financial support.” (57% match in meaning)
• Oral EPI-7386 in Patients with Castration-Resistant Prostate Cancer
  “Study was terminated early due to a lack of improved efficacy.” (57% 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.