Clinical trial NCT06506955: Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.
Official title: An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
PHASE3
Conditions: Advanced/Metastatic Cancer
Keywords: Futibatinib
TAS-120
FGFR
Cholangiocarcinoma
Breast cance
Urothelial Carcinom
Lead sponsor: Taiho Oncology, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco (UCSF)
state: California
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Barcelona
country: Spain
facility: Hospital Universitari, Vall d'Hebron
city: Madrid
country: Spain
facility: Centro Integral Oncologico
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust
Study officials:
References: