Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.
Sponsor: Taiho Oncology, Inc.
ClinicalTrials ID:NCT06506955
This nonrandomized, open-label study (TAS-120-404) enrolls patients benefiting from futibatinib, either alone or with fulvestrant, from a prior Taiho study. Eligible participants must provide consent, have no undue risk, and agree to birth control measures. The study involves oral administration of futibatinib, with or without fulvestrant, for those meeting specific criteria.
Patient Parameters
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Program Overview
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.
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.
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California, San Francisco (UCSF) | 94143 | San Francisco | California |
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