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

Taiho Pharma

Status and phase: Invitation-only; Phase 3; Phase 2

Conditions: Advanced/Metastatic Cancer

Treatments: Drug: futibatinib, fulvestrant; Drug: futibatinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06506955

TAS120-404

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

TAS-120 (futibatinib) monotherapy

Experimental group

Description:

TAS-120 tablets, oral, cycle length is defined as per antecedent study design

Treatment:

Drug: futibatinib

TAS-120 (futibatinib) combination therapy with fulvestrant

Experimental group

Description:

TAS-120 tablets in combination with fulvestrant, oral, cycle length is defined as per antecedent study design

Treatment:

Drug: futibatinib, fulvestrant