The purpose of this study is to enable patients, who are currently receiving rogaratinib in a Bayer-sponsored clinical trial (incl. NCT01976741), to continue treatment after their respective study has been closed. Another aim is to learn if rogaratinib is safe and how it affects the body. Rogaratinib is an investigational drug that may treat different types of cancer, incl. non-small-cell lung cancer, small-cell lung cancer, urothelial carcinoma, head, neck and breast cancer. The drug may stop the growth of cancer cells by targeting different cell proteins called fibroblast growth factor receptors (FGFR) that are needed for the survival of the cancer cells.
The primary objectives of the study are the continuation of rogaratinib treatment (as monotherapy or combination therapy) for patients after closure of their feeder studies and the further assessment of the safety of the drug. The secondary objective is to investigate the tolerability of rogaratinib.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Participants will be treated with investigational drug following the treatment schedule and dosing instructions from the feeder-study protocol.
Any other drug specified in the protocol of the completed Bayer clinical trials that is used in combination with rogaratinib. Not all patients receive combination therapy.
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 55 months
Incidence of treatment-emergent serious adverse events (TESAEs)
Time frame: Up to 55 months
Incidence of drug-related TEAEs
Time frame: Up to 55 months
Incidence of drug-related TESAEs
Time frame: Up to 55 months
Frequency of dose modifications
Time frame: Up to 55 months
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