Ignite Creation Date:
2024-05-06 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05161195
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2021-12-03
Brief Title:
Roll-over Study to Allow Continued Access to Ribociclib
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Post-trial Access Roll-over Study to Allow Access to Ribociclib LEE011 for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study
Status:
RECRUITING
Status Verified Date:
2024-10
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:
This is an open-label multi-center roll-over study to evaluate the long term safety of ribociclib in combination with other drugs in participants who are participating in a Novartis sponsored global study that has fulfilled requirements for its primary objectives and who in the opinion of the Investigator would benefit from continued treatment
Detailed Description:
The purpose of this study is to evaluate long-term safety and provide continued treatment to participants who are currently receiving ribociclib in combination with other drugs in a parent study that has fulfilled requirements for its primary objectives and in the opinion of the Investigator would benefit from continuing treatment at time of discontinuation from the parent study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-005184-42 | EUDRACT_NUMBER | None | None |