Conditions: Ovarian Cancer
Keywords: fallopian tube cancer pazopanib anti-angiogenesis ovarian cancer primary peritoneal cancer tyrosine kinase inhibitors gynecologic cancer
Allocation: RANDOMIZED | Intervention model: 
Enrollment: 940
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: matched placebo tablet administered orally once daily for up to 24 months arm 2: Pazopanib tablet administered orally at 800 mg once daily for up to 24 months

Interventions: intervention 1: Pazopanib intervention 2: Placebo
Intervention descriptions: intervention 1: Pazopanib 800 mg tablet daily for 104 weeks (24 months) intervention 2: Matching placebo 800 mg tablet daily, for 104 weeks (24 months).

Protocol document: