Trial Information

Summary: A Phase I, Open-Label, Dose Escalation First Time in Human Study to Evaluate the Safety Profile, Pharmacokinetics and Pharmacodynamics of GSK923295 in Subjects with Refractory Cancers

You have been asked to participate in this research study because you have a solid tumor, non-Hodgkin’s lymphoma or chronic lymphocytic leukemia that does not respond to standard therapy or for which no standard therapy exists.  The purpose of stage 1 of this study is to find the highest dose of GSK923295 that can be given to subjects with cancer without causing unmanageable side effects.  The purpose of stage 2 of this study is to evaluate how GSK923295 given at this dose is processed in the body; how GSK923295 changes cells during treatment; and if GSK923295 causes tumors to stop growing or to shrink.  The study will also evaluate how this drug is processed in the body; how GSK923295 changes cells during treatment; and if GSK923295 causes tumors to stop growing or shrink.  You may continue to receive the study drug as long as you do not have serious side effects and as long as your cancer does not get worse. After you stop taking the drug, you will be asked to come back for one more visit to your study doctor about 28-days after your last dose.  In addition, the study will try to identify genes that might be associated with why different people respond differently to and have different side effects from GSK923295, for which you will be asked to provide an additional blood sample.  Your specimen may be stored and used in laboratory research for up to 15 years after the last subject completes the study.  Participation in this pharmacogenetic research is voluntary.

Patient Inclusion/Exclusion Criteria:

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

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Trial listings updated: October 6, 2008 at 2:45:51 PM