Autopsy report · NCT01132664

Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer

“Due to the rare patient population and challenges to enroll patients.”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 4 years 3 months before it stopped.
• 72 participants enrolled.
• Results were posted on the registry 1 year 2 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 1, Phase 2

Sponsor

Novartis Pharmaceuticals

Sponsor type

Industry

Conditions

Metastatic Breast Cancer; HER2+ Breast Cancer

Interventions

BKM120; Trastuzumab; Capecitabine

Participants

72

Sites

21

Countries

Belgium, France, Italy, Spain, United Kingdom, United States

Trials that died the same way

• Intra-erythrocyte Dexamethasone Versus Placebo in Patients With Steroid-dependent Crohn's Disease
  “due to the difficulty to enroll suitable patients” (76% match in meaning)
• Intraductal Papillary Mucinous Neoplasm With Malignant Change
  “Because patient enrollment is so difficult.” (71% match in meaning)
• Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)
  “difficulty of enrolling patients” (71% match in meaning)
• Neoadjuvant Aromatase Inhibitor(AI) With Ovarian Suppression Versus Chemotherapy in Premenopausal Breast Cancer Patients
  “Hard to enroll expected number of eligible patients.” (71% match in meaning)
• Wellness Initiative at New York University
  “Due to inability to enroll patients” (70% 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.