Trial Information

Summary: A Phase I Dose-Escalation, Pharmacokinetic and Pharmacodynamic Study of TG01 Tablets in Combination with Erlotinib in Non-Small Cell Lung Cancer in Patients

You have been asked to participate in this research study because you have advanced non-small cell lung cancer (NSCLC) which has not responded to standard treatment..  The purpose of this research study is to determine the highest dose of the investigational drug TG01 that can be given with erlotinib which shows biological activity without unmanageable side effects.  Repeated blood samples will be drawn throughout the study in order to determine how long the two drugs remain in the body.  Researchers will also analyze blood and tumor specimens to identify biomarkers (proteins in the blood) which may be indicators of how well NSCLC is responding to treatment.  Lastly, blood specimens will be genotyped to look for the relationship between certain genes and how the study drug is eliminated from the body.  Your treatment on this study is expected to last for as long as your cancer is not growing and you are not having unmanageable side effects. After your treatment on this study is over, your medical condition will continue to be followed indefinitely.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

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Trial listings updated: June 2, 2008 at 2:51:05 PM