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

Phase 2

Completed

• Conditions: Cancer
• Interventions: Drug: Rogaratinib (BAY1163877); Drug: Combination drug

• Registration Number: NCT04125693
• Lead Sponsor: Bayer

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.

Study Timeline

• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-14
• Study Start: 2019-10-30
• Primary Completion: 2021-02-16
• Study Completion: 2021-02-16
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-20
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cancer patients	Rogaratinib (BAY1163877)	Patients from completed Bayer clinical trials, who received rogaratinib as monotherapy or combination therapy for the treatment of cancer.
Cancer patients	Combination drug	Patients from completed Bayer clinical trials, who received rogaratinib as monotherapy or combination therapy for the treatment of cancer.

Primary Outcome Measures

Name	Time	Method
Incidence of drug-related TEAEs	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 TESAEs	Up to 55 months

Secondary Outcome Measures

Name	Time	Method
Frequency of dose modifications	Up to 55 months

Trial Locations

Locations (1)

Kantonsspital St. Gallen; 🇨🇭 St. Gallen, Sankt Gallen, Switzerland