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Brief Title: A Phase 1b Study Of Axitinib In Combination With Crizotinib In Patients With Advanced Solid Tumors
Official Title: A PHASE 1B, OPEN LABEL, DOSE ESCALATION STUDY TO EVALUATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AXITINIB (AG-013736) IN COMBINATION WITH CRIZOTINIB (PF-02341066) IN PATIENTS WITH ADVANCED SOLID TUMORS
Study ID: NCT01999972
Brief Summary: Despite the success of anti-angiogenic therapy in multiple treatment settings, a fraction of patients are refractory to vascular endothelial growth factor (VEGF) inhibitor treatment, while the majority of patients will eventually develop evasive resistance. It is proposed that mesenchymal-epithelial transition factor (c-MET) and its ligand hepatocyte growth factor (HGF or scatter factor) contribute to VEGF inhibitor resistance, such that combining a c-MET inhibitor with a VEGF inhibitor will provide additional clinical activity compared to VEGF inhibitor alone. This hypothesis will be tested using the cMET/ALK inhibitor, crizotinib, in combination with the VEGF inhibitor, axitinib.Since this will be the first study of axitinib given in combination with crizotinib, the study will primarily assess the safety and tolerability of the combination regimen.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Chicago Medical Center, Chicago, Illinois, United States
Investigational Drug Services IUHSCC, Indianapolis, Indiana, United States
IU Health University Hospital, Indianapolis, Indiana, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Wayne State University, Dept. of Oncology, Detroit, Michigan, United States
University of Minnesota Health Clinics and Surgery Center, Minneapolis, Minnesota, United States
University of Minnesota Medical Center, Fairview IDS Pharmacy, Minneapolis, Minnesota, United States
University of Minnesota Medical Center, Fairview, Minneapolis, Minnesota, United States
University of Minnesota Physicians Masonic Cancer Center, Minneapolis, Minnesota, United States
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy, Cleveland, Ohio, United States
Huntsman Cancer Hospital, Salt Lake City, Utah, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
John A Moran Eye Center, Salt Lake City, Utah, United States
University Station Ophthalmology Clinic, Madison, Wisconsin, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
St Bartholomew's Hospital - Barts Health NHS Trust, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, Royal Marsden Hospital, London, , United Kingdom
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR