Roll-over Study to Continue Treatment With the Investigational Drug Rogaratinib and to Further Test Its Safety

March 20, 2022 updated by: Bayer

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

Completed

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

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Sankt Gallen
      • St. Gallen, Sankt Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Cancer patients
Patients from completed Bayer clinical trials, who received rogaratinib as monotherapy or combination therapy for the treatment of cancer.
Drug: Rogaratinib (BAY1163877)
Participants will be treated with investigational drug following the treatment schedule and dosing instructions from the feeder-study protocol.
Other Names:
  • FGFR 1-4 inhibitor
Drug: Combination drug
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.

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
Up to 55 months
Incidence of treatment-emergent serious adverse events (TESAEs)
Time Frame: Up to 55 months
Up to 55 months
Incidence of drug-related TEAEs
Time Frame: Up to 55 months
Up to 55 months
Incidence of drug-related TESAEs
Time Frame: Up to 55 months
Up to 55 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of dose modifications
Time Frame: Up to 55 months
Up to 55 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2019

Primary Completion (Actual)

February 16, 2021

Study Completion (Actual)

February 16, 2021

Study Registration Dates

First Submitted

October 11, 2019

First Submitted That Met QC Criteria

October 11, 2019

First Posted (Actual)

October 14, 2019

Study Record Updates

Last Update Posted (Actual)

April 1, 2022

Last Update Submitted That Met QC Criteria

March 20, 2022

Last Verified

March 1, 2022

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)?

Undecided

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

No

Studies a U.S. FDA-regulated device product

No

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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