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Efficacy and Safety of Pazopanib Monotherapy After First Line Chemotherapy in Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This study is not yet open for participant recruitment.
Verified by GlaxoSmithKline, April 2009
First Received: March 19, 2009   Last Updated: April 16, 2009   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00866697
  Purpose

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
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Carcinoma
Drug: Pazopanib
Drug: Placebo
Phase III

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Pazopanib
U.S. FDA Resources
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Progression Free Survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • 3-year PFS [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • PFS by GCIG criteria [ Designated as safety issue: No ]
  • Quality of Life [ Designated as safety issue: No ]
  • Overall Survival [ Designated as safety issue: No ]

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
Arm A: Experimental Drug: Pazopanib
Pazopanib 800 mg daily for 52 weeks (12 months)
Arm B: Placebo Comparator Drug: Placebo
Matching placebo 800 mg daily, for 52 weeks (12 months).

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • written informed consent
  • At least 18 years old.
  • Histologically confirmed, FIGO stage II-IV epithelial ovarian, fallopian tube or primary peritoneal carcinoma that was treated with surgical debulking and at least five cycles of platinum-taxane doublet chemotherapy.
  • Study randomization at least 3 weeks and not more than 12 weeks from the date of the last chemotherapy dose, and all major toxicities from the previous chemotherapy must have resolved.
  • No evidence of disease progression
  • ECOG status of 0 or 1.
  • Able to swallow and retain oral medication.
  • Adequate hematologic, hepatic, and renal system function as follows:

Hematologic

  • Absolute neutrophil count (ANC) at least 1.5 X 10^9/L
  • Hemoglobin at least 9 g/dL (or 5.59 mmol/L)
  • Platelets at least 100 X 10^9/L
  • Prothrombin time (PT) or international normalized ratio (INR) up to 1.2 X ULN
  • Activated partial thromboplastin time (aPTT) up to 1.2 X ULN Hepatic
  • Total bilirubin up to 1.5 X ULN
  • AST and ALT up to 2.5 X ULN Renal
  • Serum creatinine up to 1.5 mg/dL

Or, if greater than 1.5 mg/dL:

Calculated creatinine clearance at least 50 mL/min Urine Protein

  • Urine protein is 0, trace, or +1 determined by dipstick urinalysis, or < 1.0 gram determined by 24- hour urine protein analysis.
  • Non-childbearing potential (i.e., physiologically incapable of becoming pregnant) OR childbearing potential, and agrees to use adequate contraception.

Exclusion Criteria:

  • Either (a) bulky disease, or (b) any residual disease which in the opinion of the investigator will need imminent second-line therapy
  • Synchronous primary endometrial carcinoma, or a past history of primary endometrial carcinoma, are excluded unless certain conditions are met.
  • Clinically significant gastrointestinal abnormalities
  • Prolongation of corrected QT interval (QTc) > 480 msecs
  • History of any one or more cardiovascular conditions within the past 6 months prior to randomization
  • Poorly controlled hypertension
  • History of cerebrovascular accident (including transient ischemic attacks), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months prior to randomization
  • Major surgery (including interval debulking) or trauma within 28 days, or minor surgical procedures within 7 days, prior to randomization, or has any non-healing wound, fracture, or ulcer.
  • Evidence of active bleeding or bleeding diathesis.
  • Hemoptysis within 6 weeks prior to randomization.
  • Endobronchial metastases.
  • Serious and/or unstable pre-existing medical (e.g., uncontrolled infection), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
  • Investigational or anti-VEGF anticancer therapy prior to study randomization.
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00866697

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

  Show 146 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

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

Keywords provided by GlaxoSmithKline:
pazopanib
tyrosine kinase inhibitors
anti-angiogenesis
gynecologic cancer
ovarian cancer
fallopian tube cancer
primary peritoneal cancer

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009