A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Peritoneal Cancer

Fallopian Tube Cancer

Ovarian Cancer

Neoplasms, Ovarian

Treatments

Drug: GW786034

Study type

Interventional

Funder types

Industry

Identifiers

NCT00281632

104450

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

Female

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.