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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months after the study completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months after the study completion
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 moreSide effects data
From 2021 Phase 1 & 2 trial • 407 Patients • NCT0205277888%
Hyperphosphataemia
44%
Alanine aminotransferase increased
38%
Diarrhoea
29%
Vomiting
26%
Constipation
26%
Fatigue
24%
Aspartate aminotransferase increased
21%
Asthenia
18%
Decreased appetite
18%
Headache
15%
Abdominal pain
15%
Alopecia
12%
Dry mouth
12%
Muscular weakness
12%
Nausea
12%
Hemiparesis
12%
Hypoaesthesia
12%
Anaemia
9%
Oropharyngeal pain
9%
Weight increased
9%
Dyspepsia
9%
Stomatitis
9%
Muscle spasms
9%
Blood alkaline phosphatase increased
9%
Gamma-glutamyltransferase increased
9%
Arthralgia
6%
Dry skin
6%
Ageusia
6%
Seizure
6%
Weight decreased
6%
Hypercalcaemia
6%
Insomnia
6%
Hypokalaemia
6%
Gastrooesophageal reflux disease
6%
Rash maculo-papular
6%
Platelet count decreased
6%
Lymphocyte count decreased
6%
Hiccups
6%
Urinary retention
6%
Conjunctivitis
6%
Blood creatinine increased
6%
Phlebitis
6%
Abdominal pain upper
6%
Bronchitis
6%
Confusional state
6%
Lymphopenia
6%
Pain
6%
Dizziness
6%
Vertigo
6%
Mucosal dryness
6%
Pain in extremity
6%
Back pain
6%
Mouth ulceration
6%
Hypophosphataemia
6%
Dysgeusia
6%
Palmar-plantar erythrodysaesthesia syndrome
6%
Blood bilirubin increased
6%
Urinary tract infection
6%
Dysphagia
3%
Swelling face
3%
Hypotension
3%
General physical health deterioration
3%
Disorientation
3%
Hyperkalaemia
3%
Paronychia
3%
Pruritus
3%
Memory impairment
3%
Intracranial mass
3%
Blood calcium increased
3%
Thrombocytopenia
3%
Gait disturbance
3%
Hyperglycaemia
3%
Hyponatraemia
3%
Onychalgia
3%
Musculoskeletal pain
3%
Paraesthesia
3%
Epistaxis
3%
Hyperuricaemia
3%
Dyspnoea
3%
Pulmonary thrombosis
3%
White blood cell count decreased
3%
Nail discolouration
3%
Vulvovaginal dryness
3%
Ventricular tachycardia
3%
Onycholysis
3%
Rectal haemorrhage
3%
Tremor
3%
Onychomadesis
3%
Blood phosphorus increased
3%
Proteinuria
3%
Rash
3%
Pharyngitis
3%
Mental status changes
3%
Balance disorder
3%
Nasal congestion
3%
Tinnitus
3%
Deep vein thrombosis
3%
Nuclear magnetic resonance imaging brain abnormal
3%
Subarachnoid haemorrhage
3%
Abdominal discomfort
3%
Flatulence
3%
Neutrophil count decreased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Dose Expansion: Cohort 2
Phase 1: Dose Expansion: Cohort 5
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
12,920 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious eye condition affecting my retina.I have had local cancer treatment in the last 4 weeks.My cancer is a type of bile duct cancer that cannot be surgically removed.I haven't had major surgery or extensive radiotherapy in the last 4 weeks.I do not have major stomach or bowel problems that could affect medicine absorption.I haven't had targeted or immune therapy in the last 3 weeks.I currently have a serious infection.My cancer has a specific genetic change in the FGFR2 gene.My brain metastasis has been stable for at least 1 month.I have another cancer that is getting worse or needs treatment.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had non-study cancer treatment in the last 3 weeks or still have side effects.My organs are working well.I have received treatment targeting FGFR before.I do not have any severe medical, psychiatric conditions or abnormal lab results.I have been treated with gemcitabine and platinum for bile duct cancer.I haven't had a heart attack or severe heart issues in the last 2 months.My latest treatment didn't stop my cancer from growing.My cancer can be measured by tests.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm A
- Group 2: Treatment Arm B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.