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:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-24 @ 9:10 PM
NCT ID:
NCT00243204
Eligibility Criteria:
INCLUSION CRITERIA:
* Men or women age 18 years or older
* Histologically or cytologically confirmed NSCLC
* Recurrent, locally advanced or metastatic, inoperable NSCLC (Stage IIIB/IV)
* Patients with Stage IIIB NSCLC must have a cytologically documented pleural effusion
* Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC
* Measurable disease on computerized tomography (CT) scan
* ECOG Performance Status of 0 or 1
* Expected survival ≥12 weeks
* Provide written informed consent
EXCLUSION CRITERIA:
* More than 2 prior chemotherapy regimens
* Clinically significant laboratory abnormalities, specifically:
* Total bilirubin ≥ institutional upper limit of normal (ULN)
* Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x ULN concomitant with alkaline phosphatase \>2.5 x ULN
* Serum creatinine ≥2.0mg/dL
* Absolute neutrophil count \<1500/μL or platelets \<100,000/μL
* Untreated or symptomatic brain metastases
* Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
* A history of severe hypersensitivity to drugs formulated with polysorbate 80
* Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
* Patients who are within 28 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for NSCLC.
* Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00243204
Study Brief:
Protocol Section:
NCT00243204