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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04125693
• Other study ID #: 20252
• Secondary ID: 2019-000808-15
• Status: Completed
• Phase: Phase 2
• Start date: October 30, 2019
• Est. completion date: February 16, 2021

Study information

• Verified date: March 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: February 16, 2021
• Est. primary completion date: February 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• Rogaratinib (BAY1163877)
Participants will be treated with investigational drug following the treatment schedule and dosing instructions from the feeder-study protocol.
• 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.

Locations

Country	Name	City	State
Switzerland	Kantonsspital St. Gallen	St. Gallen	Sankt Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs)		Up to 55 months
Primary	Incidence of treatment-emergent serious adverse events (TESAEs)		Up to 55 months
Primary	Incidence of drug-related TEAEs		Up to 55 months
Primary	Incidence of drug-related TESAEs		Up to 55 months
Secondary	Frequency of dose modifications		Up to 55 months

External Links

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