1010014
Research type
Research Study
Full title
An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study
IRAS ID
1010014
Contact name
Volker Wacheck
Contact email
Sponsor organisation
Taiho Oncology, Inc.
Eudract number
2024-512217-40
Clinicaltrials.gov Identifier
Research summary
The purpose of this nonrandomized, open-label, multicenter rollover study is to provide continued access to futibatinib as monotherapy or combination therapy for participants who are participating in a current Taiho-sponsored futibatinib study (antecedent study) and who are continuing to derive clinical benefit from these treatments with no undue risk. The protocol is designed to be used in conjunction with the antecedent futibatinib protocols and references the antecedent protocols for key procedural details.
Participants will continue to receive futibatinib as monotherapy or as combination therapy as per the dosing regimen provided within the antecedent protocol. The length of each treatment cycle will also remain the same as the parent study that they are currently participating in. Participants will be enrolled in one of the following cohorts:
1. Futibatinib as monotherapy
2. Futibatinib in combination with fulvestrant
Patients will receive study treatment until progression of disease, unacceptable toxicity, or until another discontinuation or withdrawal criterion is met.
There are 3 study periods in this rollover study: the Study Period, the Treatment Period and the Safety Follow-up Period. The Study Period begins on the day when the participant signs this PIS-ICF and continues until the last day of the Safety Follow-up Period. The Treatment Period is from the first day of dosing until the last day of dosing. The Safety Follow-up Period is from the last day of dosing to the day of the safety follow-up visit. The safety follow-up visit will occur approximately 30 days after the last dose of study treatment, the day before the start of any new antitumour therapy, or the day the participant no longer wish to participate in the study, whichever is earliest.
Safety of patients enrolled will be monitored through the Safety Follow-up period or until patient withdrawal. All serious adverse events and nonserious treatment-related adverse events will be collected.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
24/NW/0190
Date of REC Opinion
25 Jul 2024
REC opinion
Further Information Favourable Opinion