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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00866697 |
This is a study to determine whether therapy with pazopanib is effective and safe in women with epithelial ovarian, fallopian tube, or primary peritoneal cancer whose cancer has not progressed on first line chemotherapy.
Condition | Intervention | Phase |
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Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Carcinoma |
Drug: Pazopanib Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | A Phase III Study to Evaluate the Efficacy and Safety of Pazopanib Monotherapy Versus Placebo in Women Who Have Not Progressed After First Line Chemotherapy for Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer |
Estimated Enrollment: | 900 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | December 2014 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A: Experimental |
Drug: Pazopanib
Pazopanib 800 mg daily for 52 weeks (12 months)
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Arm B: Placebo Comparator |
Drug: Placebo
Matching placebo 800 mg daily, for 52 weeks (12 months).
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This is a randomized, two-arm, placebo controlled, double-blind, multicenter, intergroup Phase III study in women with non-bulky FIGO Stage II - IV ovarian, fallopian tube, or primary peritoneal cancer that has not progressed (i.e., CR, PR, SD) after completing their first-line chemotherapy for advanced ovarian cancer. Approximately 900 subjects will be enrolled into the study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Hematologic
Or, if greater than 1.5 mg/dL:
Calculated creatinine clearance at least 50 mL/min Urine Protein
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 110655, AGO-OVAR16 |
Study First Received: | March 19, 2009 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00866697 History of Changes |
Health Authority: | Denmark: Danish Medicines Agency; Europe: European Medicines Agency; France: Agence Française de Sécurité Sanitaire des Produits de Santé; Germany: Bundesinstitut für Arzneimittel und Medizinprodukte; Hong Kong: Department of Health; Japan: Ministry of Health, Labor and Welfare; Norway: Statens Legemiddelverk; South Korea: Food and Drug Administration; Spain: Agencia Española del Medicamento y Productos Sanitarios; Sweden: Medical Products Agency; Taiwan: Department of Health; United States: Food and Drug Administration; United States: Institutional Review Board; Australia: Human Research Ethics Committee; Australia: Medicines Australia; Austria: Agency for Health and Food Safety; China: State Food and Drug Administration |
pazopanib tyrosine kinase inhibitors anti-angiogenesis gynecologic cancer |
ovarian cancer fallopian tube cancer primary peritoneal cancer |
Fallopian Tube Cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Fallopian Tube Neoplasms |
Carcinoma Fallopian Tube Diseases Genital Diseases, Female Ovarian Cancer Endocrinopathy Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Ovarian Neoplasms Neoplasms by Histologic Type Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Fallopian Tube Neoplasms |
Fallopian Tube Diseases Carcinoma Adnexal Diseases Genital Diseases, Female Neoplasms Neoplasms by Site Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |