A phase III study to evaluate the efficacy and safety of pazopanib monotherapy versus placebo in women whose disease has not progressed after first-line chemotherapy for epithelial ovarian, fallopian tube or primary peritoneal cancer

 

Trial Summary:

This study is for women who have FIGO stages II-IV ovarian, fallopian tube or primary peritoneal cancer that has not progressed after first-line chemotherapy. Approximately 900 women are being randomly allocated to pazopanib, 800 mg daily, or placebo. Treatment continues for 52 weeks unless the participant dies or discontinues treatment. The primary objective of the study is to determine whether pazopanib prolongs progression-free survival. Throughout the study, all participants have safety and efficacy assessments, which include physical examinations, blood tests, CT or MRI scans and questionnaires.

Supported By:

GlaxoSmithKline; Australia New Zealand Gynaecological Oncology Group (ANZGOG); Arbeitsgemeinschaft Gynackologisehe Onkologie (AGO) Ovarian Cancer Study Group

Eligibility:

Women with epithelial ovarian, fallopian tube, or primary peritoneal cancer

Registration ID:

ACTRN12609000591257

Participation:

International

Australian Lead Group:

ANZGOG

Status:

Follow Up

Activation Date:

14/08/2009

Chairs:

Michael Friedlander (Australia)

Contact:

ovar16.study@sydney.edu.au