Study Completed

Cancer

Bayer Identifier:

20252

ClinicalTrials.gov Identifier:

NCT04125693

EudraCT Number:

2019-000808-15

EU CT Number:

Not Available

Roll-over study to continue treatment with the investigational drug rogaratinib and to further test its safety

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A

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

Trial summary

Enrollment Goal

Trial Dates

October 2019 - February 2021

Phase

Phase 2

Could I Receive a placebo

Products

Rogaratinib (BAY1163877)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Withdrawn	Severance Hospital, Yonsei University Health System	Seoul, 03722, Korea, Republic Of
Withdrawn	Samsung Medical Center	Seoul, 06351, Korea, Republic Of
Completed	Kantonsspital St. Gallen	St. Gallen, 9007, Switzerland

Primary Outcome

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

Secondary Outcome

Frequency of dose modifications
Time Frame:
Up to 55 months

Trial design

A roll-over study to provide continued treatment with rogaratinib in participants who were enrolled in rogaratinib studies

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

N/A

Blinding

N/A

Assignment

Single Group Assignment

Trial Arms

Additional Information

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