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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00281632




Registration number
NCT00281632
Ethics application status
Date submitted
23/01/2006
Date registered
25/01/2006
Date last updated
17/09/2018

Titles & IDs
Public title
A Phase II, Open-Label Study Evaluating the Effect Of GW786034 In Subjects With Ovarian Cancer
Scientific 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.
Secondary ID [1] 0 0
104450
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peritoneal Cancer 0 0
Ovarian Cancer 0 0
Neoplasms, Ovarian 0 0
Fallopian Tube Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - GW786034

Experimental: Pazopanib - 800 mg GW786034 administered orally on a daily basis.


Treatment: Drugs: GW786034
800 mg GW786034 administered orally on a daily basis.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Best Biochemical Response (Cancer Antigen [CA-125])
Timepoint [1] 0 0
Baseline to response (up to 3 years)
Secondary outcome [1] 0 0
Time to Biochemical Response (CA-125)
Timepoint [1] 0 0
Baseline to response (up to 3 years)
Secondary outcome [2] 0 0
Duration of Biochemical Response (CA-125)
Timepoint [2] 0 0
Baseline to response (up to 3 years)
Secondary outcome [3] 0 0
CA-125 Doubling Time Prior to and During Treatment With Pazopanib
Timepoint [3] 0 0
Baseline to doubling of CA-125 (up to 3 years)
Secondary outcome [4] 0 0
Overall Response and Stable Disease (SD)
Timepoint [4] 0 0
Baseline to response (up to 3 years)
Secondary outcome [5] 0 0
Median Progression-free Survival (PFS)
Timepoint [5] 0 0
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 outcome [6] 0 0
Overall Tumor Response
Timepoint [6] 0 0
Baseline to response (up to 3 years)
Secondary outcome [7] 0 0
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure
Timepoint [7] 0 0
Baseline to response (up to 3 years)
Secondary outcome [8] 0 0
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure
Timepoint [8] 0 0
Baseline to response (up to 3 years)
Secondary outcome [9] 0 0
Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate
Timepoint [9] 0 0
Baseline to response (up to 3 years)
Secondary outcome [10] 0 0
Mean Change From Baseline to Response in Albumin
Timepoint [10] 0 0
Baseline to response (up to 3 years)
Secondary outcome [11] 0 0
Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase
Timepoint [11] 0 0
Baseline to response (up to 3 years)
Secondary outcome [12] 0 0
Mean Change From Baseline to Response in Amylase and Lipase
Timepoint [12] 0 0
Baseline to response (up to 3 years)
Secondary outcome [13] 0 0
Mean Change From Baseline to Response in Total Bilirubin and Creatinine
Timepoint [13] 0 0
Baseline to response (up to 3 years)
Secondary outcome [14] 0 0
Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea
Timepoint [14] 0 0
Baseline to response (up to 3 years)
Secondary outcome [15] 0 0
Mean Change From Baseline to Response in Thyroxine
Timepoint [15] 0 0
Baseline to response (up to 3 years)
Secondary outcome [16] 0 0
Mean Change From Baseline to Response in Thyroid Stimulating Hormone
Timepoint [16] 0 0
Baseline to response (up to 3 years)
Secondary outcome [17] 0 0
Mean Change From Baseline to Response in Hemoglobin and Hematocrit
Timepoint [17] 0 0
Baseline to response (up to 3 years)
Secondary outcome [18] 0 0
Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count
Timepoint [18] 0 0
Baseline to response (up to 3 years)

Eligibility
Key inclusion 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.
Minimum age
21 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2010
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [2] 0 0
GSK Investigational Site - Herston
Recruitment hospital [3] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
3084 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Singapore
State/province [3] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials, MD
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00281632