- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04125693
Roll-over Study to Continue Treatment With the Investigational Drug Rogaratinib and to Further Test Its Safety
A Roll-over Study to Provide Continued Treatment With Rogaratinib in Participants Who Were Enrolled in Rogaratinib Studies
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Sankt Gallen
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St. Gallen, Sankt Gallen, Switzerland, 9007
- Kantonsspital St. Gallen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Cancer patients
Patients from completed Bayer clinical trials, who received rogaratinib as monotherapy or combination therapy for the treatment of cancer.
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Participants will be treated with investigational drug following the treatment schedule and dosing instructions from the feeder-study protocol.
Other Names:
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Up to 55 months
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Up to 55 months
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Incidence of treatment-emergent serious adverse events (TESAEs)
Time Frame: Up to 55 months
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Up to 55 months
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Incidence of drug-related TEAEs
Time Frame: Up to 55 months
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Up to 55 months
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Incidence of drug-related TESAEs
Time Frame: Up to 55 months
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Up to 55 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of dose modifications
Time Frame: Up to 55 months
|
Up to 55 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 20252
- 2019-000808-15 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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