This study is accepting new patients by invitation only

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

a study on Advanced/Metastatic Cancer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around

Description

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.

Official Title

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

Details

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.

Keywords

Advanced/Metastatic Cancer, Futibatinib, TAS-120, FGFR, Cholangiocarcinoma, Breast cance, Urothelial Carcinom, Neoplasm Metastasis, Fulvestrant, futibatinib, fulvestrant, TAS-120 (futibatinib) monotherapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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).

You CAN'T join if...

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

Location

  • UCSF (UCSF)
    San Francisco California 94143 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Taiho Oncology, Inc.
ID
NCT06506955
Phase
Phase 2/3 Advanced/Metastatic Cancer Research Study
Study Type
Interventional
Participants
Expecting 15 study participants
Last Updated