Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506955
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-06-28
Brief Title:
Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
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 a nonrandomized open-label multicenter rollover study for patients who received futibatinib as monotherapy or as combination therapy in a Taiho-sponsored futibatinib study
Detailed Description:
TAS-120-404 is a nonrandomized open-label multicenter rollover study for patients who received futibatinib as monotherapy or as combination therapy in a Taiho-sponsored futibatinib study
Patients who are still receiving futibatinib as monotherapy or as combination therapy are deriving clinical benefit with no undue risk as assessed by the investigator and have not met any of the antecedent protocol-specific discontinuation criteria are eligible to participate
Patients who are still receiving futibatinib as monotherapy or as combination therapy are deriving clinical benefit with no undue risk as assessed by the investigator and have not met any of the antecedent protocol-specific discontinuation criteria are eligible to participate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None