Roll-over Study to Continue Treatment With the Investigational Drug Rogaratinib and to Further Test Its Safety

Bayer

Status and phase

Completed

Phase 2

Conditions

Cancer

Treatments

Drug: Rogaratinib (BAY1163877)

Drug: Combination drug

Study type

Interventional

Funder types

Industry

Identifiers

NCT04125693

2019-000808-15 (EudraCT Number)

20252

Details and patient eligibility

About

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.

Full 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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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