Status:
ENROLLING_BY_INVITATION
Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.
Lead Sponsor:
Taiho Oncology, Inc.
Conditions:
Advanced/Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Provide written informed consent.
- Receiving futibatinib as monotherapy or as combination therapy in an antecedent futibatinib study and deriving clinical benefit with no undue risk as assessed by the investigator.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to receiving treatment. Both males and females of reproductive potential must agree to use effective birth control during study treatment and for a specified time after the last dose of study treatment.
- Ability to take medications orally (PO) (feeding tube is not permitted).
Exclusion
- • Has met any discontinuation criteria within the antecedent futibatinib study.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06506955
Start Date
October 1 2024
End Date
December 31 2026
Last Update
July 1 2025
Active Locations (9)
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1
University of California, San Francisco (UCSF)
San Francisco, California, United States, 94143
2
Institut Paoli-Calmettes
Marseille, France, 13009
3
Institut De Cancerologie Strasbourg
Strasbourg, France, 67033
4
Severance Hospital
Seoul, South Korea, 3722