check_circleStudy Completed
Advanced or metastatic solid tumor
Bayer Identifier:
19774
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
16Trial Dates
July 2018 - February 2021Phase
Phase 1Could I Receive a placebo
NoProducts
Rogaratinib (BAY1163877)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Universitätsklinikum Köln | Köln, 50937, Germany |
Completed | Klinikum der Universität Würzburg | Würzburg, 97080, Germany |
Completed | Krankenhaus Nordwest | Frankfurt, 60488, Germany |
Withdrawn | Universitätsklinikum Hamburg Eppendorf (UKE) | Hamburg, 20246, Germany |
Completed | Memorial Sloan-Kettering Cancer Center | New York, 10065, United States |
Completed | Dana-Farber Cancer Institute | Boston, 02215, United States |
Completed | Barbara Ann Karmanos Cancer Institute - Detroit | Detroit, 48201, United States |
Completed | Northwestern University | Chicago, 60611, United States |
Completed | CU Saint-Luc/UZ St-Luc | BRUXELLES - BRUSSEL, 1200, Belgium |
Completed | CHU de Liège | LIEGE, 4000, Belgium |
Completed | UZ Antwerpen | EDEGEM, 2650, Belgium |
Completed | Samsung Medical Center | Seoul, 06351, Korea, Republic Of |
Withdrawn | Centre Oscar Lambret - Lille | LILLE cedex, 59020, France |
Withdrawn | Centre Léon Bérard | LYON CEDEX, 69008, France |
Completed | Severance Hospital, Yonsei University Health System | Seoul, 03722, Korea, Republic Of |
Completed | Asan Medical Center | Seoul, 05505, Korea, Republic Of |
Completed | National University Hospital | Singapore, 119074, Singapore |
Completed | National Cancer Center Singapore | Singapore, 169610, Singapore |
Completed | Ciutat Sanitària i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Withdrawn | Hospital Clínic i Provincial de Barcelona | Barcelona, 08036, Spain |
Withdrawn | Hospital General Universitario Gregorio Marañón | Madrid, 28007, Spain |
Completed | Hospital Clínico Universitario de Valencia | Valencia, 46010, Spain |
Withdrawn | MD Anderson International Espanya, S.A. | Madrid, 28033, Spain |
Completed | USC Norris Hospital and Clinics | Los Angeles, 90033, United States |
Completed | University of Maryland | Baltimore, 21201, United States |
Withdrawn | Prisma Health | Greenville, 29605, United States |
Completed | Tyler Cancer Center | Tyler, 75702, United States |
Withdrawn | Texas Oncology- Austin Midtown | Austin, 78705, United States |
Withdrawn | Comprehensive Cancer Centers of Nevada | Las Vegas, 89169, United States |
Primary Outcome
- Incidence of treatment-emergent adverse events (TEAEs)date_rangeTime Frame:Up to 32 months
- Incidence of drug-related TEAEsdate_rangeTime Frame:Up to 32 months
- Incidence of treatment-emergent serious adverse events (TESAEs)date_rangeTime Frame:Up to 32 months
- Incidence of Dose-limiting toxicities (DLTs)date_rangeTime Frame:Approximately 10 months
- Objective response rate (ORR) at recommended doseORR in patients receiving the recommended dose of the rogaratinib-copanlisib-combination during the dose expansion partdate_rangeTime Frame:Up to 32 months
Secondary Outcome
- Maximum plasma concentration of Copanlisib (Cmax)date_rangeTime Frame:0 (pre-dose), 0.5, 1 (end of infusion), 2, 4, 8, 24, 48 hours after drug administration (Days 1, 2, 3) and 0, 0.5, 1, 2, 4, 8, 24, 48 hours after drug administration (Days 15, 16, 17) in dose escalation
- Area under the plasma concentration versus time curve of Copanlisib (AUC (0-48))date_rangeTime Frame:0 (pre-dose), 0.5, 1 (end of infusion), 2, 4, 8, 24, 48 hours after drug administration (Days 1, 2, 3) and 0, 0.5, 1, 2, 4, 8, 24, 48 hours after drug administration (Days 15, 16, 17) in dose escalation
- Area under the plasma concentration versus time curve of Rogaratinib (AUC (0-8))date_rangeTime Frame:0 (pre-dose), 0.5, 1, 2, 4, 6, 8 hours after drug (Day 14) and 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 24, 48 hours after drug (Days 15 to 17) in dose escalation; 0 (pre-dose) and 1 hour after drug on Day 1 of dose expansion
- Maximum plasma concentration of Rogaratinib (Cmax)date_rangeTime Frame:0 (pre-dose), 0.5, 1, 2, 4, 6, 8 hours after drug (Day 14) and 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 24, 48 hours after drug (Days 15 to 17) in dose escalation; 0 (pre-dose) and 1 hour after drug on Day 1 of dose expansion
- Objective response rate (ORR)date_rangeTime Frame:Up to 32 months
- Disease control rate (DCR)date_rangeTime Frame:Up to 32 months
- Duration of response (DOR) for Partial Response and Complete Responsedate_rangeTime Frame:Up to 32 months
- Progression-free survival (PFS)date_rangeTime Frame:Up to 32 months
- Overall survival (OS)date_rangeTime Frame:Up to 32 months
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
Single Group AssignmentTrial Arms
1