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

Part of paid clinical trials in San Francisco, California.

Sponsor
Taiho Oncology, Inc.
Study ID
NCT06506955
Phase
PHASE2/PHASE3
Status
Enrolling By Invitation

Conditions

  • Advanced/Metastatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • futibatinib — DRUG
    TAS-120 futibatinib monotherapy
  • futibatinib, fulvestrant — DRUG
    TAS-120 futibatinib combination therapy with fulvestrant

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
May 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TAS-120 (futibatinib) monotherapy
    TAS-120 tablets, oral, cycle length is defined as per antecedent study design
  • Experimental: TAS-120 (futibatinib) combination therapy with fulvestrant
    TAS-120 tablets in combination with fulvestrant, oral, cycle length is defined as per antecedent study design

Primary Outcome 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. [ Time Frame: through study completion, an average of 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San Francisco (UCSF)San FranciscoCalifornia94143-

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University of California, San Francisco (UCSF)· San Francisco, CA