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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Malignant Tumor of Peritoneum; Ovarian Cancer; Neoplasms, Ovarian; Fallopian Tube Cancer

Intervention: GW786034 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Clinical Details

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 design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Best Biochemical Response (Cancer Antigen [CA-125])

Secondary outcome:

Time to Biochemical Response (CA-125)

Duration of Biochemical Response (CA-125)

CA-125 Doubling Time Prior to and During Treatment With Pazopanib

Overall Response and Stable Disease (SD)

Median Progression-free Survival (PFS)

Overall Tumor Response

Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Diastolic Blood Pressure

Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Systolic Blood Pressure

Number of Participants With the Indicated Maximum Shift From Baseline (BL) in Heart Rate

Mean Change From Baseline to Response in Albumin

Mean Change From Baseline to Response in Alkaline Phosphatase, Alanine Aminotransferase, Aspartate Aminotransferase, and Lactate Dehydrogenase

Mean Change From Baseline to Response in Amylase and Lipase

Mean Change From Baseline to Response in Total Bilirubin and Creatinine

Mean Change From Baseline to Response in Calcium, Glucose, Potassium, Sodium, and Urea

Mean Change From Baseline to Response in Thyroxine

Mean Change From Baseline to Response in Thyroid Stimulating Hormone

Mean Change From Baseline to Response in Hemoglobin and Hematocrit

Mean Change From Baseline to Response in Lymphocytes, Neutrophils, Platelet Count, and White Blood Count

Eligibility

Minimum age: 21 Years. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

GSK Investigational Site, Melbourne 3084, Australia

GSK Investigational Site, Singapore 119074, Singapore

GSK Investigational Site, Singapore 229899, Singapore

GSK Investigational Site, Atlanta, Georgia 30342, United States

GSK Investigational Site, Randwick, New South Wales 2031, Australia

GSK Investigational Site, Herston, Queensland 4029, Australia

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

Additional Information

Related 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.

Starting date: March 2006
Last updated: March 17, 2011

Page last updated: August 23, 2015

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