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Summary

for females ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

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

Details

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.

Keywords

Neoplasms, Ovarian fallopian tube cancer pazopanib anti-angiogenesis ovarian cancer primary peritoneal cancer tyrosine kinase inhibitors gynecologic cancer

Eligibility

You can join if…

Open to females ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Novartis Investigative Site
    San Francisco, California, 94115, United States
  • Novartis Investigative Site
    South San Francisco, California, 94080, United States
  • Novartis Investigative Site
    Oakland, California, 94611, United States
  • Novartis Investigative Site
    Hayward, California, 94545, United States
  • Novartis Investigative Site
    Walnut Creek, California, 94596, United States
  • Novartis Investigative Site
    Vallejo, California, 94589, United States
  • Novartis Investigative Site
    Santa Clara, California, 95051, United States
  • Novartis Investigative Site
    San Jose, California, 95119-1110, United States
  • Novartis Investigative Site
    Sacramento, California, 95817, United States
  • Novartis Investigative Site
    Sacramento, California, 95825, United States
  • Novartis Investigative Site
    Roseville, California, 95661, United States
  • Novartis Investigative Site
    Panorama City, California, 91402, United States
  • Novartis Investigative Site
    Woodland Hills, California, 91367, United States
  • Novartis Investigative Site
    Los Angeles, California, 90027, United States
  • Novartis Investigative Site
    Los Angeles, California, 90034, United States
  • Novartis Investigative Site
    Duarte, California, 91010, United States
  • Novartis Investigative Site
    Baldwin Park, California, 91706, United States
  • Novartis Investigative Site
    Bellflower, California, 90706, United States
  • Novartis Investigative Site
    Los Angeles, California, 90095, United States
  • Novartis Investigative Site
    Long Beach, California, 90806, United States
  • Novartis Investigative Site
    Ontario, California, 91761, United States
  • Novartis Investigative Site
    Fontana, California, 92335, United States
  • Novartis Investigative Site
    Anaheim, California, 92807, United States
  • Novartis Investigative Site
    Orange, California, 92868, United States
  • Novartis Investigative Site
    Riverside, California, 92505, United States
  • Novartis Investigative Site
    Irvine, California, 92618, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT00866697
Phase
Phase 3
Lead Scientist
Lee-May Chen
Study Type
Interventional
Last Updated
June 1, 2017