Monotherapy Pazopanib in Subjects With Advanced Non-Small Cell Lung Cancer

Stopped early · Phase 2

Conditions studied: Lung Cancer, Non-Small Cell

In brief

This study is designed to evaluate the efficacy and safety of monotherapy pazopanib (a small molecule tyrosine kinase inhibitor of VEGFR-1, VEGFR-2, VEGFR-3, PDGF, and c-kit) in subjects with advanced (Stage IIIB or IV) non-small cell lung cancer.

Key facts

Study ID

NCT00549328

Run by

GlaxoSmithKline

People needed

14

Starts

2008-02-01

Expected to finish

2009-04-01

Last updated by the study team

2014-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed consent
• Histologically- or cytologically confirmed diagnosis of Stage IIIB or IV non-small cell lung cancer.
• Failed no more than two prior chemotherapy regimens for Stage IIIB or IV non-small cell lung cancer, including a platinum-containing regimen.
• Brain metastases permitted if subject has been treated with surgery and/or radiation therapy more than 4 weeks prior to date of first dose and is stable for at least one week off steroids.
• 18 years of age or older.
• Eastern Cooperative Oncology Group performance status of at least 2.
• Measurable disease according to RECIST.
• Adequate organ system function.
• Females may be eligible to enroll if they are of non-childbearing potential (surgically sterile or post-menopausal)or are using appropriate contraception methods.

You may not qualify if…

• Prior malignancy - unless disease-free for at least 3 years, or have had completely resected non-melanomatous skin cancer or successfully treated in situ carcinoma.
• History or clinical evidence of central nervous system metastases or leptomeningeal carcinomatosis, except for subjects with previously-treated CNS metastases, who are asymptomatic, and have had no requirement for steroids or anti-seizure medication for one week prior to first dose of study drug.
• Clinically significant gastrointestinal abnormalities.
• Presence of uncontrolled infection.
• Corrected QT interval greater than 480 msec.
• History of significant cardiovascular condition(s).
• Poorly controlled hypertension (systolic blood pressure of 140mmHG or greater or diastolic blood pressure of 90mmHg or greater).
• History of cerebrovascular accident, pulmonary embolism, or insufficiently treated deep venous thrombosis within the past 6 months prior to first dose of study drug.
• Major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer.
• Active bleeding or diathesis.
• Hemoptysis in excess of 2.5mL within 8 weeks of first dose of study drug.
• Serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance with study procedures.
• Use of prohibited medications as defined in protocol.
• Use of an investigational agent, including an investigational anti-cancer agent within 28 days, or 5 half-lives, whichever is longer, prior to first dose of study drug.
• Prior use of any investigational or licensed anti-angiogenic agent, including thalidomide and agents that target platelet-derived growth factor. Prior treatment with bevacizumab or epidermal growth factor receptor tyrosine kinase inhibitors

Where it is running

• GSK Investigational Site — Scottsdale, Arizona, United States
• GSK Investigational Site — Fort Myers, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Baton Rouge, Louisiana, United States
• GSK Investigational Site — Duluth, Minnesota, United States
• GSK Investigational Site — Buffalo, New York, United States
• GSK Investigational Site — Columbus, Ohio, United States
• GSK Investigational Site — Tulsa, Oklahoma, United States
• GSK Investigational Site — Philadelphia, Pennsylvania, United States
• GSK Investigational Site — Sayre, Pennsylvania, United States
• GSK Investigational Site — Corpus Christi, Texas, United States
• GSK Investigational Site — Newport News, Virginia, United States
• GSK Investigational Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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