The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of GRN163L when administered in combination with a standard paclitaxel/carboplatin regimen to patients with advanced or metastatic non-small cell lung cancer.
GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
The starting dose of GRN163L for this study will be 3.2 mg/kg. Subsequent dose levels will be 4.8, 6, 7.5, 9, 11, and 13.5 mg/kg. The maximum dose to be administered will not exceed 13.5 mg/kg. Paclitaxel and carboplatin will be administered on Day 2 of each 21-day cycle.
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
The University of Texas Southwestern Medical Center
Dallas, Texas, United States
UT MD Anderson Cancer Center
Houston, Texas, United States
University of Wisconsin, Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States
Safety and MTD
Time frame: First 3 weeks
PK and efficacy
Time frame: Baseline to end of treatment
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