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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00262990
First received: December 6, 2005
Last updated: May 2, 2012
Last verified: May 2012

December 6, 2005
May 2, 2012
November 2005
February 2010   (final data collection date for primary outcome measure)
To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer [ Time Frame: every 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00262990 on ClinicalTrials.gov Archive Site
  • To determine the duration of overall response in patients with complete response (CR) or partial response (PR) or stable disease (SD) [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • To determine the progression-free survival (PFS) of patients treated with patupilone [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • To determine the time to disease progression (TTP) of patients treated with patupilone [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • To determine overall best tumor response (CR, PR, SD, PD and Unknown) [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • To investigate the safety and tolerability of patupilone [ Time Frame: end of study ] [ Designated as safety issue: Yes ]
  • To evaluate the pharmacokinetics (PK) of patupilone from all patients [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • To explore relationships between Cmin (pre-dose patupilone blood concentration) and efficacy/adverse events [ Time Frame: end of study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Neoplasms
  • Drug: EPO906 (Patupilone)
    Other Name: Patupilone
  • Drug: doxorubicin
  • Experimental: Patupilone
    Intervention: Drug: EPO906 (Patupilone)
  • Active Comparator: doxorubicin
    Intervention: Drug: doxorubicin
Colombo N, Kutarska E, Dimopoulos M, Bae DS, Rzepka-Gorska I, Bidzinski M, Scambia G, Engelholm SA, Joly F, Weber D, El-Hashimy M, Li J, Souami F, Wing P, Engelholm S, Bamias A, Schwartz P. Randomized, open-label, phase III study comparing patupilone (EPO906) with pegylated liposomal doxorubicin in platinum-refractory or -resistant patients with recurrent epithelial ovarian, primary fallopian tube, or primary peritoneal cancer. J Clin Oncol. 2012 Nov 1;30(31):3841-7. doi: 10.1200/JCO.2011.38.8082. Epub 2012 Sep 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
829
Not Provided
February 2010   (final data collection date for primary outcome measure)

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.

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Denmark,   Finland,   France,   Greece,   Italy,   Poland,   South Africa,   Spain,   United Kingdom
 
NCT00262990
CEPO906A2303
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP