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Tyrosine Kinase Inhibitor

Futibatinib for Bile Duct Cancer (FOENIX-CCA4 Trial)

Phase 2
Recruiting
Research Sponsored by Taiho Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months after the study completion
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a drug to treat a type of liver cancer with a gene mutation; it looks at safety, effectiveness, and the best dose.

Who is the study for?
This trial is for adults with advanced Cholangiocarcinoma (bile duct cancer) that has specific genetic changes called FGFR2 fusions or rearrangements. Participants must have tried at least one chemo treatment before, show signs of cancer progression after the last treatment, and be in good physical condition with proper organ function.
What is being tested?
The study is testing two doses of a drug named Futibatinib (16 mg and 20 mg) to see how well they work and how safe they are for patients who've had previous treatments for bile duct cancer with certain genetic alterations.
What are the potential side effects?
Potential side effects may include disturbances in calcium and phosphate levels, significant eye problems like retinal disorders, healing complications if recently undergone major surgery or radiotherapy, worsening heart conditions, severe gastrointestinal issues that affect drug absorption.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months after the study completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months after the study completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ORR by independent central review
Secondary study objectives
Change from Baseline in Quality of life as assessed by EORTC QLQ-C30
Change from Baseline in Quality of life as assessed by EuroQol-5D (EQ-5D )
DoR by independent review
+6 more

Side effects data

From 2021 Phase 1 & 2 trial • 407 Patients • NCT02052778
79%
Hyperphosphataemia
46%
Diarrhoea
38%
Constipation
33%
Fatigue
29%
Decreased appetite
29%
Nausea
25%
Alanine aminotransferase increased
25%
Aspartate aminotransferase increased
21%
Dyspnoea
21%
Vomiting
21%
Abdominal pain
21%
Alopecia
17%
Asthenia
17%
Stomatitis
17%
Anaemia
17%
Weight decreased
13%
Dry skin
13%
Dysgeusia
13%
Dry eye
13%
Gastrooesophageal reflux disease
13%
Dry mouth
13%
Blood creatinine increased
13%
Nail disorder
13%
Headache
13%
Onycholysis
8%
Pyrexia
8%
Urinary tract infection
8%
Musculoskeletal chest pain
8%
Arthralgia
8%
Cough
8%
Rash
8%
Oedema peripheral
8%
Blood bilirubin increased
8%
Blood alkaline phosphatase increased
8%
Intestinal obstruction
8%
Retinal detachment
8%
Back pain
8%
Cataract
8%
Musculoskeletal pain
8%
Thrombocytopenia
4%
Weight increased
4%
Mouth ulceration
4%
Palmar-plantar erythrodysaesthesia syndrome
4%
Punctate keratitis
4%
Taste disorder
4%
Dyspepsia
4%
Pruritus
4%
Pain in extremity
4%
Hypercalcaemia
4%
Blood creatine phosphokinase increased
4%
Lower respiratory tract infection
4%
Neutropenia
4%
Muscular weakness
4%
Ileus
4%
Paronychia
4%
Lung infection
4%
Hypophosphataemia
4%
Gastric haemorrhage
4%
Gamma-glutamyltransferase increased
4%
Muscle spasms
4%
Tendonitis
4%
Peripheral sensory neuropathy
4%
Hypotension
4%
Vulvovaginal dryness
4%
Oropharyngeal pain
4%
Abdominal pain upper
4%
Small intestinal haemorrhage
4%
Acute myocardial infarction
4%
Cholangitis
4%
Tooth infection
4%
Insomnia
4%
Dysuria
4%
Renal failure
4%
Dysphagia
4%
Lymphocyte count decreased
4%
Neuropathy peripheral
4%
Bronchitis
4%
Inguinal hernia
4%
Spinal cord compression
4%
Vision blurred
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Dose Expansion: Cohort 5
Phase 1: Dose Expansion: Cohort 2
Phase 1: Dose Expansion: Sub-cohort 2
Phase 1: Dose Escalation: QOD Dosing: 24 mg
Phase 1: Dose Escalation: QOD Dosing: 160 mg
Phase 1: Dose Escalation: QD Dosing: 4 mg
Phase 1: Dose Escalation: QD Dosing: 8 mg
Phase 1: Dose Escalation: QOD Dosing: 36 mg
Phase 1: Dose Escalation: QOD Dosing: 56 mg
Phase 1: Dose Expansion: Cohort 4
Phase 1: Dose Expansion: Cohort 6
Phase 1: Dose Escalation: QOD Dosing: 8 mg
Phase 1: Dose Escalation: QOD Dosing: 80 mg
Phase 1: Dose Escalation: QOD Dosing: 120 mg
Phase 1: Dose Escalation: QOD Dosing: 16 mg
Phase 1: Dose Escalation: QD Dosing: 24 mg
Phase 1: Dose Expansion Cohort 1
Phase 2
Phase 1: Dose Escalation: QOD Dosing: 200 mg
Phase 1: Dose Escalation: QD Dosing: 16 mg
Phase 1: Dose Escalation: QD Dosing: 20 mg
Phase 1: Dose Expansion: Cohort 3
Phase 1: Dose Expansion: Sub-cohort 1

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment Arm BExperimental Treatment1 Intervention
TAS-120 (16mg) tablets, oral; 21-day cycle
Group II: Treatment Arm AExperimental Treatment1 Intervention
TAS-120 (20mg) tablets, oral; 21-day cycle

Find a Location

Who is running the clinical trial?

Taiho Oncology, Inc.Lead Sponsor
78 Previous Clinical Trials
12,970 Total Patients Enrolled

Media Library

Futibatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05727176 — Phase 2
Chromosomal Rearrangement Research Study Groups: Treatment Arm A, Treatment Arm B
Chromosomal Rearrangement Clinical Trial 2023: Futibatinib Highlights & Side Effects. Trial Name: NCT05727176 — Phase 2
Futibatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05727176 — Phase 2
~33 spots leftby Jun 2025
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