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

Ovarian Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00281632
• Other study ID #: 104450
• Status: Completed
• Phase: Phase 2
• Start date: March 2006
• Est. completion date: October 2010

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2010
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Neoplasms, Glandular and Epithelial
• Neoplasms, Ovarian
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Cancer

Intervention

Drug:
• GW786034
800 mg GW786034 administered orally on a daily basis.

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Herston	Queensland
Australia	GSK Investigational Site	Melbourne
Australia	GSK Investigational Site	Randwick	New South Wales
Singapore	GSK Investigational Site	Singapore
Singapore	GSK Investigational Site	Singapore
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Bedford	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Singapore, 

References & Publications (1)

Friedlander M, Hancock KC, Rischin D, Messing MJ, Stringer CA, Matthys GM, Ma B, Hodge JP, Lager JJ. A Phase II, open-label study evaluating pazopanib in patients with recurrent ovarian cancer. Gynecol Oncol. 2010 Oct;119(1):32-7. doi: 10.1016/j.ygyno.2010.05.033. Epub 2010 Jun 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Biochemical Response (Cancer Antigen [CA-125])	Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: 50% response==50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments) then confirmed after 21 days. 50% CA-125 response was normalized (CA-125 >21U/mL) or non-normalized (CA-125=1U/mL). Progressive disease (PD) =CA-125 increase =100% from nadir (nadir >21U/mL) or =42U/mL (nadir =21U/mL); nadir was lowest CA-125. PD was confirmed after 21 days; otherwise=unconfirmed PD. Stable disease=scenarios that do not meet 50% response or PD. CA-125 response rate was defined as % of participants with 50% response.	Baseline to response (up to 3 years)
Secondary	Time to Biochemical Response (CA-125)	Time to biochemical response was calculated as the date pazopanib was first dosed to the date CA-125 was first reduced by 50% or greater. The reduction in CA-125 of 50% or greater was to be confirmed by a repeat measurement (no earlier than 21 days after initial evaluation documenting decrement). This was calculated for all participants with confirmed CA-125 50% reduction.	Baseline to response (up to 3 years)
Secondary	Duration of Biochemical Response (CA-125)	Calculated as the date of confirmed first 50% or greater reduction in CA-125 to date of documented progression by clinical, radiographic, or biochemical criteria, whichever occurred earliest. This was calculated for all participants with confirmed CA-125 50% reduction.	Baseline to response (up to 3 years)
Secondary	CA-125 Doubling Time Prior to and During Treatment With Pazopanib	CA-125 doubling time is defined as the time for CA-125 to double from baseline value. This measure was not reported, as no participants had a post-baseline CA-125 that was double the baseline value. Therefore, the data did not warrant a report.	Baseline to doubling of CA-125 (up to 3 years)
Secondary	Overall Response and Stable Disease (SD)	Overall response and stable disease (SD) are based on biochemical, radiographic, and clinical assessments according to the modified criteria of Gynecologic Cancer Intergroup (GCIG) (see primary outcome). Response is presented as the percentage of participants with the given response.	Baseline to response (up to 3 years)
Secondary	Median Progression-free Survival (PFS)	Progression-free survival analysis was performed on all participants and then stratified by CA-125 response status (having confirmed 50% reduction or not). PFS was defined as the time from the 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.	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)
Secondary	Overall Tumor Response	Overall tumor response following daily administration of pazopanib was defined using radiographic assessments based on Response Evaluation Criteria for Solid Tumors (RECIST) criteria for subjects with measurable disease at baseline.	Baseline to response (up to 3 years)
Secondary	Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure	Summary of shifts in diastolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.	Baseline to response (up to 3 years)
Secondary	Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure	Summary of shifts in systolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.	Baseline to response (up to 3 years)
Secondary	Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate	Summary of shifts in heart rate from baseline to the maximum change in the study. bpm, beats per minute.	Baseline to response (up to 3 years)
Secondary	Mean Change From Baseline to Response in Albumin	Change from baseline is calculated as the value at the time of response minus the value at Baseline.	Baseline to response (up to 3 years)
Secondary	Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase	Change from baseline is calculated as the value at the time of response minus the value at Baseline.	Baseline to response (up to 3 years)
Secondary	Mean Change From Baseline to Response in Amylase and Lipase	Change from baseline is calculated as the value at the time of response minus the value at Baseline.	Baseline to response (up to 3 years)
Secondary	Mean Change From Baseline to Response in Total Bilirubin and Creatinine	Change from baseline is calculated as the value at the time of response minus the value at Baseline.	Baseline to response (up to 3 years)
Secondary	Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea	Change from baseline is calculated as the value at the time of response minus the value at Baseline.	Baseline to response (up to 3 years)
Secondary	Mean Change From Baseline to Response in Thyroxine	Change from baseline is calculated as the value at the time of response minus the value at Baseline.	Baseline to response (up to 3 years)
Secondary	Mean Change From Baseline to Response in Thyroid Stimulating Hormone	Change from baseline is calculated as the value at the time of response minus the value at Baseline.	Baseline to response (up to 3 years)
Secondary	Mean Change From Baseline to Response in Hemoglobin and Hematocrit	Change from baseline is calculated as the value at the time of response minus the value at Baseline.	Baseline to response (up to 3 years)
Secondary	Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count	Change from baseline is calculated as the value at the time of response minus the value at Baseline.	Baseline to response (up to 3 years)