Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-02-23 @ 2:32 AM
Study NCT ID:
NCT04125693
Status:
COMPLETED
Last Update Posted:
2022-04-01
First Post:
2019-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Roll-over Study to Continue Treatment With the Investigational Drug Rogaratinib and to Further Test Its Safety
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
A Roll-over Study to Provide Continued Treatment With Rogaratinib in Participants Who Were Enrolled in Rogaratinib Studies
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
The secondary objective is to investigate the tolerability of rogaratinib.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-000808-15 | EUDRACT_NUMBER | None | View |