Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-26 @ 9:35 PM
Study NCT ID:
NCT04148092
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2020-05-29
First Post:
2019-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access Program of Ripretinib (DCC-2618) for the Treatment of Patients With Advanced GIST
Sponsor:
Deciphera Pharmaceuticals, LLC
Organization:
Study Overview
Official Title:
Expanded Access Program for Ripretinib in Patients With Locally Advanced Unresectable or Metastatic GIST Who Have Received Treatment With Prior Therapies
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label, single-arm, multicenter expanded access study to provide patients who have locally advanced unresectable or metastatic gastrointestinal stromal tumor (GIST) and have received treatment with at least 2 prior Food and Drug Administration (FDA)-approved therapies early access to ripretinib until such time that ripretinib becomes commercially available or the Sponsor chooses to discontinue the program.
Detailed Description:
The EAP is no longer enrolling patients in the United States.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: