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

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

July 25, 2018

Primary Completion Date

February 1, 2021

Study Completion Date

February 1, 2021

Conditions
Advanced or Metastatic Solid Tumor
Interventions
DRUG

Rogaratinib (BAY1163877)

"Dose escalation:~Starting dose is rogaratinib 400 mg twice daily (b.i.d.) in continuous 28-day cycles from Cycle 1 Day 3 onwards.~Dose expansion:~With dose identified in dose escalation part."

DRUG

Copanlisib (BAY80-6946)

"Dose escalation:~Starting dose is 45 mg on Days 1, 8 and 15 of each 28-day cycle.~Dose expansion:~With dose identified in dose escalation part."

Trial Locations (20)

1200

CU Saint-Luc/UZ St-Luc, Bruxelles - Brussel

2650

UZ Antwerpen, Edegem

4000

CHU de Liège, Liège

10065

Memorial Sloan-Kettering Cancer Center, New York

21201

University of Maryland, Baltimore

46010

Hospital Clínico Universitario de Valencia, Valencia

48201

Barbara Ann Karmanos Cancer Institute - Detroit, Detroit

50937

Universitätsklinikum Köln, Cologne

60488

Krankenhaus Nordwest, Frankfurt am Main

60611

Northwestern University, Chicago

75702

Tyler Cancer Center, Tyler

90033

USC Norris Hospital and Clinics, Los Angeles

97080

Klinikum der Universität Würzburg, Würzburg

119074

National University Hospital, Singapore

169610

National Cancer Center Singapore, Singapore

02215

Dana-Farber Cancer Institute, Boston

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08035

Ciutat Sanitària i Universitaria de la Vall d'Hebron, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY