Clinical trial · Interventional
Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib as Monotherapy or Combination Therapy.
An Open-label, Rollover Study of Futibatinib in Patients Previously Enrolled in an Antecedent Futibatinib Study
NCT06506955CI-TRIAL-00119566active not recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced/Metastatic Cancer | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| futibatinib | Drug | Futibatinib | ALIAS |
| futibatinib, fulvestrant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TAS-120 (futibatinib) monotherapy
- description
- TAS-120 tablets, oral, cycle length is defined as per antecedent study design
- interventionNames
- Drug: futibatinib
- type
- EXPERIMENTAL
- label
- TAS-120 (futibatinib) combination therapy with fulvestrant
- description
- TAS-120 tablets in combination with fulvestrant, oral, cycle length is defined as per antecedent study design
- interventionNames
- Drug: futibatinib, fulvestrant
Primary outcomes (1)
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.