EUCTR2008-004672-50-FR
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced Ovarian Cancer (FIGO Stage II, Stage III, and Stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer)
- Sponsor
- GlaxoSmithKline Research & Development Ltd
- Enrollment
- 900
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •A subject will be considered eligible for inclusion in this study if all the following criteria are met:
- •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 \= 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 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
- •\-CT or MRI scan taken within 6 weeks prior to randomization showing no radiological progression, and
- •\-CA\-125 measurement taken within 6 weeks prior to randomization showing no CA\-125 progression (according to the GCIG criteria, Appendix 2\), and
- •\- no other clinical evidence of disease progression.
Exclusion Criteria
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •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 \= 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
Outcomes
Primary Outcomes
Not specified
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