Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
NCT ID:
NCT00549328
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00549328
Study Brief:
Protocol Section:
NCT00549328