Cancer
Conditions
Keywords
Fibroblast growth factor receptors (FGFR) Inhibitor, FGFR 1-4, Non-small-cell lung cancer, Small-cell lung cancer, Urothelial carcinoma, Adenoidcystic carcinoma, Head cancer, Neck cancer, Breast cancer
Brief summary
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.
Detailed description
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.
Interventions
Participants will be treated with investigational drug following the treatment schedule and dosing instructions from the feeder-study protocol.
DRUGCombination drug
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.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants enrolled in any Bayer-sponsored rogaratinib feeder study at the time of study closure, who are currently receiving rogaratinib (monotherapy or combination therapy) and are experiencing clinical benefit from treatment, determined by the treating physician. * Participants who meet criteria to initiate a subsequent cycle of therapy, as determined by the guidelines of the feeder study protocol. * Any ongoing adverse events that required temporary treatment interruption must be resolved to baseline grade or assessed as stable and not requiring further treatment interruption. * Women of childbearing potential and men with reproductive potential must be willing to continue practicing acceptable methods of birth control during the study treatment and until 6 months after stopping study treatment.
Exclusion criteria
* Ineligibility, for medical reasons, to start the next treatment cycle in the respective feeder study. * Patients with a beta-human chorionic gonadotropin (hCG) test consistent with pregnancy. * Participants are using one or more of the prohibited medications listed in the respective feeder study protocol * Negative benefit / risk ratio as determined by the investigator * Positive pregnancy test for on-treatment participants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of drug-related TESAEs | Up to 55 months |
| Incidence of treatment-emergent adverse events (TEAEs) | Up to 55 months |
| Incidence of treatment-emergent serious adverse events (TESAEs) | Up to 55 months |
| Incidence of drug-related TEAEs | Up to 55 months |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of dose modifications | Up to 55 months |
Countries
Switzerland
Outcome results
None listed