Brief Title
A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer
Official Title
This Study is a Non-randomized, Open-label, Multi-center Phase II Study of GW786034 to Evaluate the Administration of Oral GW786034 in Subjects With Ovarian Cancer.
Brief Summary
This study was designed to find out how effective and safe GW786034, is in the treatment of
epithelial ovarian, fallopian tube, or primary peritoneal cancer that has not responded to
standard treatment.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Best Biochemical Response (Cancer Antigen [CA-125])
Secondary Outcome
Time to Biochemical Response (CA-125)
Condition
Peritoneal Cancer
Intervention
GW786034
Study Arms / Comparison Groups
Pazopanib
Description: 800 mg GW786034 administered orally on a daily basis.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
35
Start Date
March 2006
Completion Date
October 2010
Primary Completion Date
April 2008
Eligibility Criteria
Inclusion criteria:
- Confirmed diagnosis of epithelial ovarian, fallopian tube or primary peritoneal
carcinoma.
- Has received one prior platinum-based chemotherapy regimen(cisplatin,carboplatin, or
oxaliplatin).
- Has psychological, familial, sociological or geographical condition that does not
permit compliance with the protocol.
- Is on a specifically prohibited medication or requires these medications during
treatment with GW786034.
Exclusion criteria:
- Has had any surgery, chemotherapy, hormonal therapy, biologic, immunotherapy, or
radiotherapy with in the last 28 days and has not recovered from such prior therapy.
- Poorly controlled hypertension(systolic 140mmHg or higher or Diastolic 90mmHg or
higher).
- Currently taking warfarin.
- Low molecular weight heparin and low-dose warfarin(1mg per day)is permitted.
Gender
Female
Ages
21 Years - N/A
Accepts Healthy Volunteers
No
Contacts
GSK Clinical Trials, MD, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00281632
Organization ID
104450
Responsible Party
Sponsor
Study Sponsor
GlaxoSmithKline
Study Sponsor
GSK Clinical Trials, MD, Study Director, GlaxoSmithKline
Verification Date
February 2011