Clinical trial NCT00281632: A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Peritoneal Cancer
Ovarian Cancer
Neoplasms, Ovarian
Fallopian Tube Cancer
Keywords: Pazopanib
Fallopian tube cancer
Ovarian epithelial cancer
Peritoneal cancer
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-01-25
Enrollment: 35
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Best Biochemical Response (Cancer Antigen [CA-125])
timeFrame: Baseline to response (up to 3 years)
Secondary outcomes:
measure: Time to Biochemical Response (CA-125)
timeFrame: Baseline to response (up to 3 years)
measure: Duration of Biochemical Response (CA-125)
timeFrame: Baseline to response (up to 3 years)
measure: CA-125 Doubling Time Prior to and During Treatment With Pazopanib
timeFrame: Baseline to doubling of CA-125 (up to 3 years)
measure: Overall Response and Stable Disease (SD)
timeFrame: Baseline to response (up to 3 years)
measure: 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)
measure: Overall Tumor Response
timeFrame: Baseline to response (up to 3 years)
measure: Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure
timeFrame: Baseline to response (up to 3 years)
measure: Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure
timeFrame: Baseline to response (up to 3 years)
measure: Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate
timeFrame: Baseline to response (up to 3 years)
measure: Mean Change From Baseline to Response in Albumin
timeFrame: Baseline to response (up to 3 years)
measure: Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase
timeFrame: Baseline to response (up to 3 years)
measure: Mean Change From Baseline to Response in Amylase and Lipase
timeFrame: Baseline to response (up to 3 years)
measure: Mean Change From Baseline to Response in Total Bilirubin and Creatinine
timeFrame: Baseline to response (up to 3 years)
measure: Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea
timeFrame: Baseline to response (up to 3 years)
measure: Mean Change From Baseline to Response in Thyroxine
timeFrame: Baseline to response (up to 3 years)
measure: Mean Change From Baseline to Response in Thyroid Stimulating Hormone
timeFrame: Baseline to response (up to 3 years)
measure: Mean Change From Baseline to Response in Hemoglobin and Hematocrit
timeFrame: Baseline to response (up to 3 years)
measure: Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count
timeFrame: Baseline to response (up to 3 years)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Bedford
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: GSK Investigational Site
state: Texas
city: Randwick
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Herston
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Melbourne
country: Australia
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
city: Singapore
country: Singapore
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
citation: 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.