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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT04125693

Collaborator

(none)

Enrollment

Location

Arm

15.6

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: Rogaratinib (BAY1163877) Drug: Combination drug	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Roll-over Study to Provide Continued Treatment With Rogaratinib in Participants Who Were Enrolled in Rogaratinib Studies

Actual Study Start Date :

Oct 30, 2019

Actual Primary Completion Date :

Feb 16, 2021

Actual Study Completion Date :

Feb 16, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cancer patients Patients from completed Bayer clinical trials, who received rogaratinib as monotherapy or combination therapy for the treatment of cancer.	Drug: Rogaratinib (BAY1163877) Participants will be treated with investigational drug following the treatment schedule and dosing instructions from the feeder-study protocol. Other Names: FGFR 1-4 inhibitor Drug: Combination 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.

Arm

Intervention/Treatment

Experimental: Cancer patients

Patients from completed Bayer clinical trials, who received rogaratinib as monotherapy or combination therapy for the treatment of cancer.

Drug: Rogaratinib (BAY1163877)

Participants will be treated with investigational drug following the treatment schedule and dosing instructions from the feeder-study protocol.

Other Names:

FGFR 1-4 inhibitor

Drug: Combination 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.

Outcome Measures

Primary Outcome Measures

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]
Incidence of drug-related TESAEs [Up to 55 months]

Secondary Outcome Measures

Frequency of dose modifications [Up to 55 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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