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 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT00064350
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC)
* Disease must have progressed after at least 2 prior chemotherapy regimens for NSCLC
* Patients must have measurable or nonmeasurable disease
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 3 times ULN (5 times ULN in patients with liver disease)
* Creatinine less than 1.5 times ULN or calculated creatinine clearance greater than 50 mL/min
* More than 3 weeks since prior chemotherapy, radiotherapy, immunotherapy or other investigational drug use
* Recovered from all prior therapy
* Fertile patients must use effective contraception
* Age \>= 18
* ECOG performance status of 0-1
Exclusion Criteria:
* Prior primary or metastatic brain or meningeal tumors unless clinically and radiographically stable and off therapy for at least 2 months
* Active second malignancy
* Clinically evident congestive heart failure, serious cardiac arrhythmias, or symptoms of coronary heart disease
* Prior radiotherapy to the only site of measurable or evaluable disease unless there is evidence of disease progression in that site
* Prior exposure to a ras pathway inhibitor (e.g., farnesyl transferase inhibitor)
* Concurrent medications known to be metabolized by the liver with a narrow therapeutic index, including the following:
* Ketoconazole
* Itraconazole
* Quinidine
* Digoxin
* Cyclosporine
* Ritonavir
* Grapefruit products
* Carbamazepine
* Phenytoin
* Phenobarbital
* Pregnant or nursing
* Clinically serious active infection
* Medical conditions, substance abuse or psychological/social situation that would preclude study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00064350
Study Brief:
Protocol Section:
NCT00064350