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

Phase 3Active Not RecruitingNCT06506955

Taiho Oncology, Inc.15 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced/Metastatic Cancer

Interventions

futibatinibDRUG

TAS-120 futibatinib monotherapy

futibatinib, fulvestrantDRUG

TAS-120 futibatinib combination therapy with fulvestrant

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 (9)

University of California, San Francisco (UCSF)

San Francisco, California, United States

Institut Paoli-Calmettes

Marseille, France

Institut De Cancerologie Strasbourg

Strasbourg, France

Severance Hospital

Outcomes

Primary Outcomes

Number of participants with serious adverse events, treatment-related adverse events, and any AEs leading to treatment discontinuation graded according to NCI-CTCAE v5.0.

To collect long term safety information in patients continuing to receive treatment with futibatinib as monotherapy or in combination with fulvestrant who participated in a Taiho-sponsored futibatinib study and who are deriving clinical benefit with no undue risk

Time frame: through study completion, an average of 5 years

Data from ClinicalTrials.gov

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