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A Phase III Study to Evaluate the Efficacy and Safety of Pazopanib Monotherapy Versus Placebo in Women Who Have Not Progressed After First Line Chemotherapy for Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This was a study to determine whether therapy with pazopanib was effective and safe in women with epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer had not progressed on first line chemotherapy.
This was a randomized, two-arm, placebo controlled, double-blind, multicenter, intergroup Phase III study in women with non-bulky FIGO (International Federation of Gynecology and Obstetrics) Stage II - IV ovarian, fallopian tube, or primary peritoneal cancer that had not progressed (i.e., complete response (CR), partial response (PR), stable disease (SD) after completing their first-line chemotherapy for advanced ovarian cancer. Approximately 900 subjects were to be enrolled into the study. Study was closed following 3rd overall survival (OS) interim analysis as planned per protocol, which confirmed futility.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Novartis Investigative Site
Anaheim, California, United States
Novartis Investigative Site
Baldwin Park, California, United States
Novartis Investigative Site
Bellflower, California, United States
Novartis Investigative Site
Duarte, California, United States
Novartis Investigative Site
Fontana, California, United States
Novartis Investigative Site
Hayward, California, United States
Novartis Investigative Site
Irvine, California, United States
Novartis Investigative Site
Long Beach, California, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Los Angeles, California, United States
Start Date
May 26, 2009
Primary Completion Date
July 8, 2012
Completion Date
August 24, 2017
Last Updated
February 16, 2021
940
ACTUAL participants
Pazopanib
DRUG
Placebo
DRUG
Lead Sponsor
Novartis Pharmaceuticals
Collaborators
NCT04550494
NCT05039801
Data Source & Attribution
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