Phase 2
N=36
A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer
Peritoneal Cancer · Ovarian Cancer · Neoplasms, Ovarian · Fallopian Tube Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00281632 ↗Enrolled (actual)
36
Serious AEs
16.7%
Results posted
Jan 2011
Primary outcome: Primary: Best Biochemical Response (Cancer Antigen [CA-125]) — 6; 25; 56; 3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GW786034 (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- GlaxoSmithKline
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Biochemical Response (Cancer Antigen [CA-125]) |
6; 25; 56; 3; 8; 3 | — |
| SECONDARY Time to Biochemical Response (CA-125) |
29 | — |
| SECONDARY Duration of Biochemical Response (CA-125) |
113 | — |
| SECONDARY CA-125 Doubling Time Prior to and During Treatment With Pazopanib |
— | — |
| SECONDARY Overall Response and Stable Disease (SD) |
0; 5.3; 2.8; 17.6; 15.8; 16.7 | — |
| SECONDARY Median Progression-free Survival (PFS) |
168; 57; 84 | — |
| SECONDARY Overall Tumor Response |
0; 0; 5; 10; 2 | — |
| SECONDARY Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure |
0; 16; 16; 0; 0; 3 | — |
| SECONDARY Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure |
0; 13; 16; 2; 0; 0 | — |
| SECONDARY Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate |
0; 32; 3; 0; 0; 1 | — |
| SECONDARY Mean Change From Baseline to Response in Albumin |
-1.5 | — |
| SECONDARY Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase |
7.3; 13.0; 7.1; 4.62 | — |
| SECONDARY Mean Change From Baseline to Response in Amylase and Lipase |
7.32; 7.273 | — |
| SECONDARY Mean Change From Baseline to Response in Total Bilirubin and Creatinine |
0.715; 1.37 | — |
| SECONDARY Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea |
-0.038; 0.302; -0.02; 0.1; -0.227 | — |
| SECONDARY Mean Change From Baseline to Response in Thyroxine |
0.003 | — |
| SECONDARY Mean Change From Baseline to Response in Thyroid Stimulating Hormone |
0.87 | — |
| SECONDARY Mean Change From Baseline to Response in Hemoglobin and Hematocrit |
-0.53; -0.00 | — |
| SECONDARY Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count |
0.32; -0.12; -9.93; -0.28 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00281632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.