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Brief Title: Trial of Dose Escalated BGB324 in Previously Treated Non-small Cell Lung Cancer.
Official Title: Phase 1 Trial of Dose Escalated BGB324 in Combination With Docetaxel for Previously Treated Advanced Non-small Cell Lung Cancer (NSCLC)
Study ID: NCT02922777
Brief Summary: This study is being done to evaluate the safety of the investigational study drug, BGB324 when administered in combination with docetaxel, and to establish the maximum tolerated dose.
Detailed Description: Lung cancer remains the leading cause of cancer-related deaths worldwide with an estimated incidence of 1.6 million cases resulting in 1.4 million deaths in annually. Non-small-cell lung cancer (NSCLC) represents 80-85% of cases, and adenocarcinoma is the most common histology.2 The majority of NSCLC patients present with advanced or metastatic disease that is not amenable to surgical resection. Platinum-based combination chemotherapy has reached a therapeutic plateau with a median overall survival (OS) of 7.4 to 9.9 months. BGB324 is a potent selective small molecule inhibitor of Axl, a surface membrane protein kinase receptor that is over-expressed in many metastatic solid tumors and has been identified as a marker of a poor prognosis in patients with non-small cell lung cancer (NSCLC).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Covenant Health Systems/Joe Arrington Cancer Treatment and Research Center, Lubbock, Texas, United States
Name: David E Gerber, MD
Affiliation: University of Texas Southwestern Medical Center
Role: PRINCIPAL_INVESTIGATOR