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An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study
EU CTIS ID: 2024-512217-40-00
What this study is testing
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.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
You likely can't join if
- 1. Has met any discontinuation criteria within the antecedent futibatinib study.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Taiwan
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Taiwan; United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.