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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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.
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Secondary ID [1]
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104450
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Peritoneal Cancer
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Ovarian Cancer
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Neoplasms, Ovarian
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Fallopian Tube Cancer
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Condition category
Condition code
Cancer
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Ovarian and primary peritoneal
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Cancer
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Womb (Uterine or endometrial cancer)
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Intervention/exposure
Study type
Interventional(has expanded access)
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Best Biochemical Response (Cancer Antigen [CA-125])
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to response (up to 3 years)
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Secondary outcome [1]
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Time to Biochemical Response (CA-125)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline to response (up to 3 years)
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Secondary outcome [2]
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Duration of Biochemical Response (CA-125)
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline to response (up to 3 years)
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Secondary outcome [3]
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CA-125 Doubling Time Prior to and During Treatment With Pazopanib
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline to doubling of CA-125 (up to 3 years)
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Secondary outcome [4]
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Overall Response and Stable Disease (SD)
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline to response (up to 3 years)
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Secondary outcome [5]
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Median Progression-free Survival (PFS)
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Assessment method [5]
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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.
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Timepoint [5]
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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)
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Secondary outcome [6]
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Overall Tumor Response
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline to response (up to 3 years)
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Secondary outcome [7]
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Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure
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Assessment method [7]
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Summary of shifts in diastolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.
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Timepoint [7]
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Baseline to response (up to 3 years)
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Secondary outcome [8]
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Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure
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Assessment method [8]
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Summary of shifts in systolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.
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Timepoint [8]
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Baseline to response (up to 3 years)
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Secondary outcome [9]
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Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate
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Assessment method [9]
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Summary of shifts in heart rate from baseline to the maximum change in the study. bpm, beats per minute.
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Timepoint [9]
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Baseline to response (up to 3 years)
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Secondary outcome [10]
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Mean Change From Baseline to Response in Albumin
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Assessment method [10]
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Change from baseline is calculated as the value at the time of response minus the value at Baseline.
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Timepoint [10]
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Baseline to response (up to 3 years)
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Secondary outcome [11]
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Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase
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Assessment method [11]
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Change from baseline is calculated as the value at the time of response minus the value at Baseline.
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Timepoint [11]
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Baseline to response (up to 3 years)
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Secondary outcome [12]
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Mean Change From Baseline to Response in Amylase and Lipase
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Assessment method [12]
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Change from baseline is calculated as the value at the time of response minus the value at Baseline.
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Timepoint [12]
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Baseline to response (up to 3 years)
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Secondary outcome [13]
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Mean Change From Baseline to Response in Total Bilirubin and Creatinine
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Assessment method [13]
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Change from baseline is calculated as the value at the time of response minus the value at Baseline.
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Timepoint [13]
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Baseline to response (up to 3 years)
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Secondary outcome [14]
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Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea
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Assessment method [14]
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Change from baseline is calculated as the value at the time of response minus the value at Baseline.
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Timepoint [14]
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Baseline to response (up to 3 years)
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Secondary outcome [15]
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Mean Change From Baseline to Response in Thyroxine
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Assessment method [15]
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Change from baseline is calculated as the value at the time of response minus the value at Baseline.
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Timepoint [15]
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Baseline to response (up to 3 years)
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Secondary outcome [16]
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Mean Change From Baseline to Response in Thyroid Stimulating Hormone
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Assessment method [16]
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Change from baseline is calculated as the value at the time of response minus the value at Baseline.
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Timepoint [16]
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Baseline to response (up to 3 years)
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Secondary outcome [17]
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Mean Change From Baseline to Response in Hemoglobin and Hematocrit
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Assessment method [17]
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Change from baseline is calculated as the value at the time of response minus the value at Baseline.
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Timepoint [17]
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Baseline to response (up to 3 years)
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Secondary outcome [18]
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Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count
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Assessment method [18]
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Change from baseline is calculated as the value at the time of response minus the value at Baseline.
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Timepoint [18]
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Baseline to response (up to 3 years)
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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.
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Minimum age
21
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2010
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Sample size
Target
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Accrual to date
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Final
35
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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GSK Investigational Site - Randwick
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Recruitment hospital [2]
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GSK Investigational Site - Herston
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Recruitment hospital [3]
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GSK Investigational Site - Melbourne
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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3084 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Georgia
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Country [2]
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United States of America
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State/province [2]
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Texas
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Country [3]
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Singapore
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State/province [3]
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Singapore
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00281632
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Trial related presentations / publications
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.
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials, MD
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00281632
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