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Trial Title:
Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.
NCT ID:
NCT06506955
Condition:
Advanced/Metastatic Cancer
Conditions: Official terms:
Neoplasm Metastasis
Fulvestrant
Futibatinib
Conditions: Keywords:
Futibatinib
TAS-120
FGFR
Cholangiocarcinoma
Breast cance
Urothelial Carcinom
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Enrolling by invitation
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
futibatinib
Description:
TAS-120 futibatinib monotherapy
Arm group label:
TAS-120 (futibatinib) monotherapy
Other name:
TAS-120
Intervention type:
Drug
Intervention name:
futibatinib, fulvestrant
Description:
TAS-120 futibatinib combination therapy with fulvestrant
Arm group label:
TAS-120 (futibatinib) combination therapy with fulvestrant
Other name:
TAS-120 + fulvestrant
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 Criteria:
• Has met any discontinuation criteria within the antecedent futibatinib study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, San Francisco (UCSF)
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Start date:
October 1, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Taiho Oncology, Inc.
Agency class:
Industry
Source:
Taiho Oncology, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06506955
