A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer
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.
1 other identifier
interventional
35
3 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Mar 2006
Typical duration for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2006
CompletedFirst Posted
Study publicly available on registry
January 25, 2006
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
January 4, 2011
CompletedSeptember 17, 2018
February 1, 2011
2.1 years
January 23, 2006
November 25, 2009
September 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (18)
Time to Biochemical Response (CA-125)
Baseline to response (up to 3 years)
Duration of Biochemical Response (CA-125)
Baseline to response (up to 3 years)
CA-125 Doubling Time Prior to and During Treatment With Pazopanib
Baseline to doubling of CA-125 (up to 3 years)
Overall Response and Stable Disease (SD)
Baseline to response (up to 3 years)
Median Progression-free Survival (PFS)
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)
- +13 more secondary outcomes
Study Arms (1)
Pazopanib
EXPERIMENTAL800 mg GW786034 administered orally on a daily basis.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (10)
GSK Investigational Site
Atlanta, Georgia, 30342, United States
GSK Investigational Site
Austin, Texas, 78731, United States
GSK Investigational Site
Bedford, Texas, 76022, United States
GSK Investigational Site
Dallas, Texas, 75246, United States
GSK Investigational Site
Fort Worth, Texas, 76104, United States
GSK Investigational Site
Randwick, New South Wales, 2031, Australia
GSK Investigational Site
Herston, Queensland, 4029, Australia
GSK Investigational Site
Melbourne, 3084, Australia
GSK Investigational Site
Singapore, 119074, Singapore
GSK Investigational Site
Singapore, 229899, Singapore
Related 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.
PMID: 20584542BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials, MD
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
January 23, 2006
First Posted
January 25, 2006
Study Start
March 1, 2006
Primary Completion
April 1, 2008
Study Completion
October 1, 2010
Last Updated
September 17, 2018
Results First Posted
January 4, 2011
Record last verified: 2011-02