Clinical Trials Search
Clinical Trial 18685
Study Type: Treatment
Phase of Study: Phase I/II
- Alberto Chiappori
Phase I/II, First-in-Human, Dose-Escalation Study of X-396 in Patients with Advanced Solid Tumors and Expansion Phase in Patients with ALK+ Non-Small Cell Lung Cancer
This research study is being done to evaluate the safety of an investigational drug, X-396, and to determine the best dose to use for future studies. "Investigational" means that X-396 has not been approved by the United States Food and Drug Administration (FDA) for use outside of clinical studies. X-396 has not been given to humans before this study. Different genes have been shown to change and affect the development and growth of tumors. Based on laboratory studies, X-396 blocks the effects of at least 2 of these genes (ALK and MET).
Primary: *To evaluate the safety/tolerability of X-396 and determine the maximum tolerated dose (MTD) of X-396 as a single agent. Secondary: *To characterize the preliminary pharmacokinetics (PK) of X-396 given as a single agent. *To explore the preliminary biological activity and clinical tumor response after treatment with X-396 given as a single agent. Exploratory: *To observe the correlation between PK and clinical endpoints. *To evaluate the status of exploratory biomarkers and correlate with clinical outcome. *To obtain germline DNA samples for possible pharmacogenetic analysis in the event that outliers with respect to efficacy, tolerability/safety, or exposure are identified.