A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer
Trial overview
Best biochemical response (cancer antigen [CA-125])
Timeframe: Baseline to response (up to 3 years)
Time to biochemical response (CA-125)
Timeframe: Baseline to response (up to 3 years)
Duration of biochemical response (CA-125)
Timeframe: Baseline to response (up to 3 years)
CA-125 doubling time prior to and during treatment with pazopanib
Timeframe: Baseline to doubling of CA-125 (up to 3 years)
Overall response and stable disease (SD)
Timeframe: Baseline to response (up to 3 years)
Median progression-free survival (PFS)
Timeframe: Date of the first dose of study drug to the date of documented and confirmed progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest, or to date of death due to any causes (up to 2 years)
Overall tumor response
Timeframe: Baseline to response (up to 3 years)
Number of participants with the indicated maximum shift from baseline (BL) in diastolic blood pressure
Timeframe: Baseline to response (up to 3 years)
Number of participants with the indicated maximum shift from baseline (BL) in systolic blood pressure
Timeframe: Baseline to response (up to 3 years)
Number of participants with the indicated maximum shift from baseline (BL) in heart rate
Timeframe: Baseline to response (up to 3 years)
Mean change from baseline to response in albumin
Timeframe: Baseline to response (up to 3 years)
Mean change from baseline to response in alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, and lactate dehydrogenase
Timeframe: Baseline to response (up to 3 years)
Mean change from baseline to response in amylase and lipase
Timeframe: Baseline to response (up to 3 years)
Mean change from baseline to response in total bilirubin and creatinine
Timeframe: Baseline to response (up to 3 years)
Mean change from baseline to response in calcium, glucose, potassium, sodium, and urea
Timeframe: Baseline to response (up to 3 years)
Mean change from baseline to response in thyroxine
Timeframe: Baseline to response (up to 3 years)
Mean change from baseline to response in thyroid stimulating hormone
Timeframe: Baseline to response (up to 3 years)
Mean change from baseline to response in hemoglobin and hematocrit
Timeframe: Baseline to response (up to 3 years)
Mean change from baseline to response in lymphocytes, neutrophils, platelet count, and white blood count
Timeframe: Baseline to response (up to 3 years)
Participation 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 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).
- 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.
- 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.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.