NOVARTIS CGS27023A IN NON SMALL CELL LUNG CANCER PATIENTS

$0M01FY2000RRNIH

Columbia University Health Sciences, New York NY

Investigators

Linked publications & trials

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Abstract

This study is being conducted to determine the safety and tolerability of CGS 27023A therapy for stage IIIb and IV non small cell lung cancer (NSCLC) patients in combination with paclitaxel and carboplatin. Pharmocokinetic (PK) parameters will also be determined. This trial will provide preliminary information to determine the feasibility of using CGS27023A in combination with paclitaxel and carboplatin in patients with NSCLC in order to enhance the efficacy achieved with paclitaxel and carboplatin alone as it is used now for this disease. The primary objectives of this study are: 1) to establish safety and tolerability of a recommended dose and schedule of CGS27023A in combination with paclitaxel and carboplatin in stage IIIb and IV NSCLC patients. 2) to establish a maximum tolerated dose (MTD) of CGS27023A in combination with full dose paclitaxel and carboplatin in stage IIIB and IV NSCLC patients if the recommended dose and schedule of CGS27023A is not tolerated. 3) to obtain pharmacokinetic data on paclitaxel, carboplatin and CGS27023A in combination in stage IIIb and IV NSCLC patients. 4) to obtain data on absorption, distribution, metabolism and excretion (ADME) of CGS27023A.

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