Status:
COMPLETED
Roll-over Study to Continue Treatment With the Investigational Drug Rogaratinib and to Further Test Its Safety
Lead Sponsor:
Bayer
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04125693
Start Date
October 30 2019
End Date
February 16 2021
Last Update
April 1 2022
Active Locations (1)
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1
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007