Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | Roll-over Study to Continue Treatment With the Investigational Drug Rogaratinib and to Further Test Its Safety
