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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00281632
First received: January 23, 2006
Last updated: March 17, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Malignant Tumor of Peritoneum
Ovarian Cancer
Neoplasms, Ovarian
Fallopian Tube Cancer
Drug: GW786034
Phase 2

GlaxoSmithKline has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Best Biochemical Response (Cancer Antigen [CA-125]) [ Time Frame: Baseline to response (up to 3 years) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Time to Biochemical Response (CA-125) [ Time Frame: Baseline to response (up to 3 years) ] [ Designated as safety issue: No ]
    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.

  • Duration of Biochemical Response (CA-125) [ Time Frame: Baseline to response (up to 3 years) ] [ Designated as safety issue: No ]
    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.

  • CA-125 Doubling Time Prior to and During Treatment With Pazopanib [ Time Frame: Baseline to doubling of CA-125 (up to 3 years) ] [ Designated as safety issue: No ]
    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.

  • Overall Response and Stable Disease (SD) [ Time Frame: Baseline to response (up to 3 years) ] [ Designated as safety issue: No ]
    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.

  • Median Progression-free Survival (PFS) [ Time Frame: 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) ] [ Designated as safety issue: No ]
    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.

  • Overall Tumor Response [ Time Frame: Baseline to response (up to 3 years) ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure [ Time Frame: Baseline to response (up to 3 years) ] [ Designated as safety issue: No ]
    Summary of shifts in diastolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.

  • Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure [ Time Frame: Baseline to response (up to 3 years) ] [ Designated as safety issue: No ]
    Summary of shifts in systolic blood pressure from baseline to the maximum change in the study. mmHg, millimeters of mercury.

  • Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate [ Time Frame: Baseline to response (up to 3 years) ] [ Designated as safety issue: No ]
    Summary of shifts in heart rate from baseline to the maximum change in the study. bpm, beats per minute.

  • Mean Change From Baseline to Response in Albumin [ Time Frame: Baseline to response (up to 3 years) ] [ Designated as safety issue: No ]
    Change from baseline is calculated as the value at the time of response minus the value at Baseline.

  • Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase [ Time Frame: Baseline to response (up to 3 years) ] [ Designated as safety issue: No ]
    Change from baseline is calculated as the value at the time of response minus the value at Baseline.

  • Mean Change From Baseline to Response in Amylase and Lipase [ Time Frame: Baseline to response (up to 3 years) ] [ Designated as safety issue: No ]
    Change from baseline is calculated as the value at the time of response minus the value at Baseline.

  • Mean Change From Baseline to Response in Total Bilirubin and Creatinine [ Time Frame: Baseline to response (up to 3 years) ] [ Designated as safety issue: No ]
    Change from baseline is calculated as the value at the time of response minus the value at Baseline.

  • Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea [ Time Frame: Baseline to response (up to 3 years) ] [ Designated as safety issue: No ]
    Change from baseline is calculated as the value at the time of response minus the value at Baseline.

  • Mean Change From Baseline to Response in Thyroxine [ Time Frame: Baseline to response (up to 3 years) ] [ Designated as safety issue: No ]
    Change from baseline is calculated as the value at the time of response minus the value at Baseline.

  • Mean Change From Baseline to Response in Thyroid Stimulating Hormone [ Time Frame: Baseline to response (up to 3 years) ] [ Designated as safety issue: No ]
    Change from baseline is calculated as the value at the time of response minus the value at Baseline.

  • Mean Change From Baseline to Response in Hemoglobin and Hematocrit [ Time Frame: Baseline to response (up to 3 years) ] [ Designated as safety issue: No ]
    Change from baseline is calculated as the value at the time of response minus the value at Baseline.

  • Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count [ Time Frame: Baseline to response (up to 3 years) ] [ Designated as safety issue: No ]
    Change from baseline is calculated as the value at the time of response minus the value at Baseline.


Enrollment: 35
Study Start Date: March 2006
Study Completion Date: October 2010
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pazopanib
800 mg GW786034 administered orally on a daily basis.
Drug: GW786034
800 mg GW786034 administered orally on a daily basis.
Other Name: GW786034

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00281632

Locations
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30342
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78731
GSK Investigational Site
Bedford, Texas, United States, 76022
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Australia, New South Wales
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Australia, Queensland
GSK Investigational Site
Herston, Queensland, Australia, 4029
Australia
GSK Investigational Site
Melbourne, Australia, 3084
Singapore
GSK Investigational Site
Singapore, Singapore, 229899
GSK Investigational Site
Singapore, Singapore, 119074
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Publications:
Friedlander M, Hancock KC, Rischin D, Messing M, Stringer CA, Matthys G, Ma B, Hodge JP, Lager JJ. A Phase II, Open-Label Study Evaluating Pazopanib in Patients With Advanced Ovarian Cancer . [Gynecol Oncol]. 2010;119(1):32-37.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00281632     History of Changes
Other Study ID Numbers: 104450
Study First Received: January 23, 2006
Results First Received: November 25, 2009
Last Updated: March 17, 2011
Health Authority: Singapore: Health Sciences Authority
Australia: Department of Health and Ageing Therapeutic Goods Administration
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Pazopanib
Fallopian tube cancer
Ovarian epithelial cancer
Peritoneal cancer

Additional relevant MeSH terms:
Fallopian Tube Neoplasms
Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Adnexal Diseases
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms by Site
Ovarian Diseases
Peritoneal Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014