Clinical trial NCT04125693: Roll-over Study to Continue Treatment With the Investigational Drug Rogaratinib and to Further Test Its Safety
Official title: A Roll-over Study to Provide Continued Treatment With Rogaratinib in Participants Who Were Enrolled in Rogaratinib Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Keywords: Fibroblast growth factor receptors (FGFR) Inhibitor
FGFR 1-4
Non-small-cell lung cancer
Small-cell lung cancer
Urothelial carcinoma
Adenoidcystic carcinoma
Head cancer
Neck cancer
Breast cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-10-14
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: Up to 55 months
measure: Incidence of treatment-emergent serious adverse events (TESAEs)
timeFrame: Up to 55 months
measure: Incidence of drug-related TEAEs
timeFrame: Up to 55 months
measure: Incidence of drug-related TESAEs
timeFrame: Up to 55 months
Secondary outcomes:
measure: Frequency of dose modifications
timeFrame: Up to 55 months
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen
state: Sankt Gallen
Study officials:
References: