Autopsy report · NCT01495247

Phase Ib/II Trial of BEZ235 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer

“Study did not meet Phase Ib primary objective to establish the maximum tolerated dose/recommended dose for Phase II”

The sponsor’s own words in the registry.

Life of this trial

• Registered 4 months before it started.
• Ran for about 2 years 4 months before it stopped.
• 18 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 1, Phase 2

Sponsor

Novartis Pharmaceuticals

Sponsor type

Industry

Conditions

Inoperable Locally Advanced Breast Cancer; Metastatic Breast Cancer (MBC)

Interventions

BEZ235; Paclitaxel

Participants

18

Sites

3

Countries

France, Spain

Trials that died the same way

• Lenalidomide And Rituximab as Maintenance Therapy in Treating Patients With B-Cell Non-Hodgkin Lymphoma
  “Extreme toxicity in Phase I, study did not proceed to Phase II” (67% match in meaning)
• A Phase I Trial Evaluating mFOLFOX6 and Avastin With Nexavar as First-Line Treatment for Metastatic Colorectal Cancer
  “Dose limiting toxicity at the lowest planned dose level.” (66% match in meaning)
• Safety and Efficacy Evaluation of Bosutinib Plus Atezolizumab in Newly Diagnosed Chronic Leukemia Adult Patients
  “The study has been prematurely terminated due to the onset of 2 dose limiting toxicities in 2 patients.” (65% match in meaning)
• Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors
  “Study was terminated by sponsor after Phase 1b as pre-defined signals of efficacy were not met in the Phase 1b dose expansion cohort.” (61% 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.” (60% 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.