Status:
COMPLETED
A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer
Lead Sponsor:
GlaxoSmithKline
Conditions:
Peritoneal Cancer
Ovarian Cancer
Eligibility:
FEMALE
21+ years
Phase:
PHASE2
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 treatmen...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00281632
Start Date
March 1 2006
End Date
October 1 2010
Last Update
September 17 2018
Active Locations (10)
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1
GSK Investigational Site
Atlanta, Georgia, United States, 30342
2
GSK Investigational Site
Austin, Texas, United States, 78731
3
GSK Investigational Site
Bedford, Texas, United States, 76022
4
GSK Investigational Site
Dallas, Texas, United States, 75246