Monotherapy Pazopanib in Subjects With Advanced Non-Small Cell Lung Cancer
Condition: Lung Cancer, Non-Small Cell
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pazopanib (GW786034)
Intervention description: Pazopanib monotherapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anti-angiogenesis; Non-small cell lung cancer,; pazopanib (GW786034)

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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