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 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT00870532
Eligibility Criteria:
Inclusion Criteria:
1. Patients must have histologically or cytologically confirmed NSCLC
2. At least one or 2 prior lines of chemotherapy, including oral EGFR tyrosine-kinase inhibitor for metastatic disease or locally advanced unresectable disease. There should be at least 4 weeks since prior chemotherapy or radiation therapy; patients who decline conventional chemotherapy or oral EGFR tyrosine-kinase inhibitor as salvage 2nd or 3rd line treatment are also eligible.
3. Minimum body-surface area (BSA) of 1.4 m2 at point of recruitment. This is a safeguard against recruiting small-built patients who may experience adverse reaction on absolute dosing of oral vinorelbine. At this body surface area, the maximum dosing of oral vinorelbine at 120 mg/week is equivalent to 86 mg/m2/week for a patient with BSA of 1.4 m2.
4. Age \>21 years
5. ECOG performance status \<2 (Karnofsky \>60%)
6. Patients must have normal organ and marrow function as defined here: leukocytes \>3,000/mcL, absolute neutrophil count \>1,500/mcL, platelet count \> 100,000/mcL, serum bilirubin within normal institutional limits, AST(SGOT)/ALT(SGPT) \<2.5 X upper limit of normal, and creatinine within normal institutional limits or creatinine clearance \>60 mL/min/1.73 m2 for patients. These tests must be done within 1 week of study treatment.
7. Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
1. Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
2. Patients receiving any other investigational agents
3. Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Oral Vinorelbine or other agents used in study
5. Prior and / or concomitant treatment with drugs known to induce or inhibit cytochrome P450 3A4: phenytoin, carbamazepine, barbiturates, rifampicin, imidazole antifungals (such as ketoconazole, fluconazole, itraconazole, metronidazole), omeprazole and ritonavir. Patients who are taking gastric acid-lowering agents such as H2 antagonist or antacids will be evaluated regarding the need to continue with these medications. If discontinuation of these medications is medically contraindicated, the patient will be excluded as these agents are known to lower the solubility of sorafenib and hence may limit their efficacy.
6. Significant malabsorption syndrome or disease affecting the gastro-intestinal tract function
7. Significant peripheral or autonomic neuropathy affecting sensation or bowel motility
8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
9. Uncontrolled hypertension defined as systolic blood pressure \>150 mmHg or diastolic pressure \>90 mmHg despite optimal management
10. Pregnancy or breast-feeding or women of childbearing potential not using effective contraception
11. Evidence or history of bleeding diathesis or coagulopathy
12. Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
13. Pulmonary hemorrhage/bleeding event \>CTCAE grade 2 within 4 weeks of recruitment
14. Any other hemorrhage/bleeding event \>CTCAE grade 3 within 4 weeks of recruitment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT00870532
Study Brief:
Protocol Section:
NCT00870532