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A Randomized, Parallel Group, Open-label, Active Controlled, Multicenter Phase III Trial of Patupilone (EPO906) Versus Pegylated Liposomal Doxorubicin in Taxane/Platinum Refractory/Resistant Patients With Recurrent Epithelial Ovarian, Primary Fallopian or Primary Peritoneal Cancer

Phase 3
18 Years
Not Enrolling
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms

Thank you

Trial Information

A Randomized, Parallel Group, Open-label, Active Controlled, Multicenter Phase III Trial of Patupilone (EPO906) Versus Pegylated Liposomal Doxorubicin in Taxane/Platinum Refractory/Resistant Patients With Recurrent Epithelial Ovarian, Primary Fallopian or Primary Peritoneal Cancer

Inclusion Criteria:

- 18 years of age or older

- Confirmed diagnosis of ovarian, fallopian or peritoneal cancer

- No more than three chemotherapy regimens

- Most recent regimen must have been platinum based

Exclusion Criteria:

- Have an unresolved bowel obstruction

- Have had previous chemotherapy within 3 weeks

- Recovering from any surgery for any cause

Other protocol-defined inclusion/exclusion criteria will apply.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer

Outcome Time Frame:

every 8 weeks

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

November 2005

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Neoplasms
  • Epithelial ovarian cancer
  • fallopian tube cancer
  • peritoneal cancer
  • primary cancer
  • recurrent cancer
  • doxorubicin
  • taxane chemotherapy
  • platinum chemotherapy
  • Patupilone
  • taxane platinum resistant
  • Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



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