Spots Global Cancer Trial Database for Phase 1b Trial of BGJ398/BYL719 in Solid Tumors
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Trial Identification
Brief Title: Phase 1b Trial of BGJ398/BYL719 in Solid Tumors
Official Title: A Phase Ib, Open-label Study of Oral BGJ398 in Combination With Oral BYL719 in Adult Patients With Select Advanced Solid Tumors
Study ID: NCT01928459
Study Description
Brief Summary: To study the safety and efficacy of the combination of BGJ398 with BYL719 in patients whose tumors express mutations to PIK3CA with or without alterations to FGFR 1-3.
Detailed Description: This dose escalation/dose expansion study will evaluate the combination of orally administered BGJ398 in combination with orally administered BYL719. During the dose escalation part, the MTD of the combination will be determined in patients whose advanced or metastatic tumors express mutations to PIK3CA. Once the MTD has been determined, the expansion part will begin. Patients will be addd to one of three arms based on the disease type and genetic changes. Patients with metastatic colorectal cancer are not eligible for participation in the expansion part.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
H. Lee Moffitt Cancer Center & Research Institute Moffitt 4, Tampa, Florida, United States
University of Michigan Comprehensive Cancer Center SC, Ann Arbor, Michigan, United States
Karmanos Cancer Institute Dept of Onc, Detroit, Michigan, United States
Washington University School of Medicine Onc Dept, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center Onc Dept, New York, New York, United States
Vanderbilt University Medical Center Dept of Onc, Nashville, Tennessee, United States
Cancer Therapy & Research Center / UT Health Science Center SC, San Antonio, Texas, United States
Novartis Investigative Site, Parkville, Victoria, Australia
Novartis Investigative Site, Bruxelles, , Belgium
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Lyon Cedex, , France
Novartis Investigative Site, Saint Herblain cedex, , France
Novartis Investigative Site, Koeln, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Modena, MO, Italy
Novartis Investigative Site, Seoul, Korea, Korea, Republic of
Novartis Investigative Site, Amsterdam, , Netherlands
Novartis Investigative Site, Singapore, , Singapore
Novartis Investigative Site, Sevilla, Andalucia, Spain
Novartis Investigative Site, Barcelona, Catalunya, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Bellinzona, , Switzerland
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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