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

Phase 1

Conditions: Malignant Solid Tumors
MedDRA version: 21.1Level: PTClassification code: 10028997Term: Neoplasm malignant Class: 100000004864
MedDRA version: 21.1Level: LLTClassification code: 10065147Term: Malignant solid tumor Class: 10029104
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2024-512217-40-00

Lead Sponsor: Taiho Oncology Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 9

Inclusion Criteria

1. Provide written informed consent., 2. Receiving futibatinib as monotherapy or in combination with fulvestrant in an antecedent futibatinib study and deriving clinical benefit with no undue risk as assessed by the investigator., 3. Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) within 7 days prior to receiving treatment under this protocol. (Female patients are not considered to be of childbearing potential if they are permanently sterile [hysterectomy, bilateral salpingectomy, or bilateral oophorectomy] or are postmenopausal [no menses for 12 months without an alternative medical cause]). 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., 4. Ability to take medications orally (PO) (feeding tube is not permitted).

Exclusion Criteria

1. Has met any discontinuation criteria within the antecedent futibatinib study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: Not Applicable;Primary end point(s): Serious adverse events, treatment-related adverse events, and any AEs leading to treatment discontinuation graded according to NCI-CTCAE v5.0

Secondary Outcome Measures