Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.

An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study

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.

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.

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.