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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
FOENIX-CCA4 Trial 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.Check my eligibility
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.See study design
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.
FOENIX-CCA4 Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ORR by independent central review
Secondary outcome measures
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 • NCT0205277875%
Hyperphosphataemia
75%
Dry mouth
50%
Anaemia
50%
Urinary tract infection
50%
Diarrhoea
50%
Nausea
50%
Vomiting
50%
Constipation
50%
Hyponatraemia
25%
Delirium
25%
Xerosis
25%
Chorioretinopathy
25%
Hemiparesis
25%
Stomatitis
25%
Hypercalcaemia
25%
Fatigue
25%
Hypokalaemia
25%
Venous thrombosis limb
25%
Respiratory distress
25%
Nail disorder
25%
Decreased appetite
25%
Hypoalbuminaemia
25%
Hypomagnesaemia
25%
Blood creatine phosphokinase decreased
25%
Encephalopathy
25%
Onycholysis
25%
Transient ischaemic attack
25%
Thrombocytopenia
25%
Abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Dose Escalation: QOD Dosing: 120 mg
Phase 1: Dose Escalation: QD Dosing: 4 mg
Phase 1: Dose Expansion: Cohort 6
Phase 1: Dose Escalation: QOD Dosing: 16 mg
Phase 1: Dose Escalation: QD Dosing: 20 mg
Phase 1: Dose Expansion: Cohort 3
Phase 1: Dose Escalation: QOD Dosing: 36 mg
Phase 1: Dose Escalation: QOD Dosing: 200 mg
Phase 1: Dose Escalation: QOD Dosing: 8 mg
Phase 1: Dose Escalation: QD Dosing: 24 mg
Phase 1: Dose Expansion Cohort 1
Phase 1: Dose Expansion: Cohort 4
Phase 1: Dose Expansion: Sub-cohort 2
Phase 1: Dose Expansion: Sub-cohort 1
Phase 2
Phase 1: Dose Escalation: QOD Dosing: 24 mg
Phase 1: Dose Escalation: QD Dosing: 8 mg
Phase 1: Dose Expansion: Cohort 2
Phase 1: Dose Expansion: Cohort 5
Phase 1: Dose Escalation: QOD Dosing: 56 mg
Phase 1: Dose Escalation: QOD Dosing: 80 mg
Phase 1: Dose Escalation: QOD Dosing: 160 mg
Phase 1: Dose Escalation: QD Dosing: 16 mg
FOENIX-CCA4 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
66 Previous Clinical Trials
11,464 Total Patients Enrolled
5 Trials studying Cholangiocarcinoma
695 Patients Enrolled for Cholangiocarcinoma
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the therapeutic effectiveness of Treatment Arm A within acceptable parameters?
"As this is a Phase 2 trial, without any evidence yet of efficacy for Treatment Arm A, our team at Power has assigned it a safety rating of 2."
Answered by AI
How many volunteers are eligible to join this research project?
"Correct. According to clinicaltrials.gov, this medical trial has been open for recruitment since May 12th 2023 and was last edited on June 13th 2023. It is looking for 120 participants from a single centre."
Answered by AI
Are there opportunities for people to enroll in this experiment?
"According to the records found on clinicaltrials.gov, recruitment for this study is still in progress; it was initially posted on May 12th 2023 and its information last updated June 13th 2023."
Answered by AI
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