Study of Lonafarnib in Combination With Paclitaxel and Carboplatin in Patients With Non-Small Cell Lung Cancer (Study P01901)
- Registration Number
- PER-035-02
- Lead Sponsor
- SCHERING PLOUGH RESEARCH INSTITUTE,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Male or female
Histologically or cytologically 3b or 4 (metastatic) non-small cell lung cancer. Patients must meet any subcriteria as detailed in the protocol.
Age greater than or equal to 18 years old
ECOG performance status of 0 to 1
Prior diagnosis of brain metastases from NSCLC eligible provided that the brain metastases have been adequately treated, patient is neurologically stable and no new or progressive brain metastases identified.
Meets protocol requirements for specified laboratory values
Written informed consent
Appropriate use of effective contraception if of childbearing potential
Prior basal cell carcinoma or carcinoma in-situ of the cervix are eligible provided they have been treated with no evidence of disease
Prior chemotherapy for any stage of NSCLC
Prior surgery or radiation therapy within the last 2 weeks or incomplete recovery from prior procedures or therapy
Concurrent treatment or treatment within the last 2 years for any other malignancy
Grade 2 or greater nausea or Grade 1 or greater vomiting (despite antiemetic medication)
Medical conditions that would interfere with taking oral medications
Patients with bone metastases as the only site of disease
Pregnant or nursing women
Known HIV positivity or AIDS-related illness
Patients with significant QTc prolongation at baseline
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Comparison of the general survival (OS) in the population with the intention of treating the two treatment regimens by means of the stratified test of the logarithmic order.<br>Measure:To compare the overall survival (OS) of patients diagnosed with non-small cell lung cancer (NSCLC) Stage 3b or 4 treated with lonafamib in combination with paditaxel and carboplatin with that of placebo-treated patients combined with paclitaxel and carboplatin.<br>Timepoints:every 6 weeks<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Full serum blood platelet biochemistry and summary summary of the adverse event profile of patients in each group in terms of frequency and number of events.<br>Measure:To compare safety and determine the pharmacodynamic markers of biochemical activity (HDJ-2) and pharmacodynamic activity (PK) in a subgroup of patients.<br>Timepoints:every 6 weeks<br>