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Brief Title: Safety Study of XL765 (SAR245409) in Combination With Erlotinib in Adults With Solid Tumors
Official Title: A Phase 1 Dose-Escalation Study of XL765 in Combination With Erlotinib in Subjects With Solid Tumors
Study ID: NCT00777699
Brief Summary: The purpose of this study is to evaluate the safety and tolerability of XL765 in combination with erlotinib (Tarceva®) in subjects with solid tumors. XL765 is a new chemical entity that inhibits the kinases PI3K and mTOR. In preclinical studies, inactivation of PI3K has been shown to inhibit growth and induce apoptosis (programmed cell death) in tumor cells, whereas inactivation of mTOR has been shown to inhibit the growth of tumor cells. Erlotinib is an orally administered inhibitor of EGFR (also known as HER1) tyrosine kinase. It was approved by the FDA as a single agent for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen and in combination with gemcitabine for first line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Investigational Site Number 168983, Philadelphia, Pennsylvania, United States
Name: Clinical Sciences & Operations
Affiliation: Sanofi
Role: STUDY_DIRECTOR