drugset / Trial / NCT00262990

Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer

NCT00262990 ↗

Phase 3 Completed 829 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this study is to assess the safety and efficacy of patupilone compared to pegylated liposomal doxorubicin. Additionally, this study will assess the ability of patupilone to extend the survival time and potential beneficial effects in women who have nonresponsive or recurrent ovarian, primary fallopian, or primary peritoneal cancer.

Timeline

Start
2005-11
Primary completion
2010-02
Completion
—

Outcome

Missed primary endpoint

paper There was no statistically significant difference in overall survival (OS), the primary end point, between the patupilone and PLD arms (P = .195; PMID 22987083 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Subject Patupilone Small molecule 10 mg/m2 Intravenous