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 EpithelialOvarian, Fallopian Tube, or Primary Peritoneal Cancer - ND

GlaxoSmithkline0 sites900 target enrollmentJuly 20, 2009

Overview

No summary available.

Registry

who.int

Start Date

July 20, 2009

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•1\. Subject has provided written informed consent prior to performance of study\-specific procedures or assessments, and is willing to comply with treatment and follow\-up.
•Note: Procedures conducted as part of the subject?s routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures meet
•the protocol requirements.
•2\. Subject is \&\#8805; 18 years old.
•3\. Subject has histologically confirmed, FIGO stage II\-IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma that was treated with surgical debulking and at
•least five cycles of platinum\-taxane doublet chemotherapy. Note: Intravenous, intraperitoneal, or neoadjuvant platinum\-taxane doublet chemotherapy are allowed;
•for weekly therapy, three weeks are considered one cycle. Interval debulking is allowed; second look is also allowed, as long as neither procedure is related to, or
•does indicate, disease progression.
•4\. The date of study randomization must be at least 3 weeks and not more than 12 weeks from the date of the last chemotherapy dose, and all major toxicities from the previous chemotherapy must have resolved.
•5\. Subject has had no evidence of disease progression throughout their first\-line treatment and prior to study randomization, including

•1\. Subject has either (a) bulky disease (eg, ascites that causes abdominal distention or
•requires paracentesis; mesenteric thickening; or tumor masses of 2 cm or more by CT or MRI identified on the baseline scan), or (b) any residual disease which in the opinion of the investigator will need imminent second\-line therapy
•2\. Subjects with synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless ALL of the following criteria for describing the endometrial carcinoma are met
•FIGO Stage \&\#8804; IB, and
•No lymphovascular invasion, and
•Not poorly differentiated (i.e. not Grade 3 or papillary serous or clear cell)
•3\. Subject has clinically significant gastrointestinal abnormalities including, but not limited to:
•Malabsorption syndrome
•Major resection of the stomach or small bowel that could affect the absorption of study drug (eg, short bowel syndrome)
•Active peptic ulcer disease