Trials / Completed
CompletedNCT04125693
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rogaratinib (BAY1163877) | Participants will be treated with investigational drug following the treatment schedule and dosing instructions from the feeder-study protocol. |
| 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. |
Timeline
- Start date
- 2019-10-30
- Primary completion
- 2021-02-16
- Completion
- 2021-02-16
- First posted
- 2019-10-14
- Last updated
- 2022-04-01
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT04125693. Inclusion in this directory is not an endorsement.