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Brief Title: Phase 1 Study of the Combination of Rogaratinib With Copanlisib in Patients With Fibroblast Growth Factor Receptor (FGFR)-Positive, Locally Advanced or Metastatic Solid Tumors
Official Title: A Multicenter Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of the Combination of Rogaratinib and Copanlisib in Patients With FGFR-positive, Locally Advanced or Metastatic Solid Tumors
Study ID: NCT03517956
Brief Summary: The primary objective of this study is to determine the safety, tolerability, maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) and efficacy of rogaratinib in combination with copanlisib in patients with locally advanced or metastatic solid tumors that are mRNA-positive for at least one FGFR1-4 subtype. The secondary objectives of this study are to characterize the pharmacokinetics (PK) of rogaratinib and copanlisib alone and in combination, and to assess the anti-tumor efficacy of rogaratinib in combination with copanlisib for locally advanced or metastatic solid tumors that are mRNA-positive for at least one FGFR1-4 subtype.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
USC Norris Hospital and Clinics, Los Angeles, California, United States
Northwestern University, Chicago, Illinois, United States
University of Maryland, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute - Detroit, Detroit, Michigan, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Tyler Cancer Center, Tyler, Texas, United States
CU Saint-Luc/UZ St-Luc, Bruxelles - Brussel, , Belgium
UZ Antwerpen, Edegem, , Belgium
CHU de Liège, Liege, , Belgium
Krankenhaus Nordwest, Frankfurt, Hessen, Germany
Universitätsklinikum Köln, Köln, Nordrhein-Westfalen, Germany
Klinikum der Universität Würzburg, Würzburg, , Germany
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
National University Hospital, Singapore, , Singapore
National Cancer Center Singapore, Singapore, , Singapore
Ciutat Sanitària i Universitaria de la Vall d'Hebron, Barcelona, , Spain
Hospital Clínico Universitario de Valencia, Valencia, , Spain