A Phase 2 interventional study of Rogaratinib (BAY1163877) and Combination drug in Cancer, sponsored by Bayer. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-01.
Sponsored by Bayer · Phase 2, Interventional, and Treatment
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.
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.
Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients from completed Bayer clinical trials, who received rogaratinib as monotherapy or combination therapy for the treatment of cancer.
Drug: Rogaratinib (BAY1163877) · Drug: Combination drug
Participants will be treated with investigational drug following the treatment schedule and dosing instructions from the feeder-study protocol.
Also known as: FGFR 1-4 inhibitor
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.
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 55 months
Incidence of treatment-emergent serious adverse events (TESAEs)
Time frame: Up to 55 months
Incidence of drug-related TEAEs
Time frame: Up to 55 months
Incidence of drug-related TESAEs
Time frame: Up to 55 months
Frequency of dose modifications
Time frame: Up to 55 months
Plan to share: Undecided — Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bayer