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Tyrosine Kinase Inhibitor

Futibatinib for Cancer

Phase 2
Waitlist Available
Research Sponsored by Taiho Oncology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
iii. Received at least 2 prior systemic regimens for advanced/metastatic disease
iv. Experienced disease progression/recurrence during or after the most recent prior systemic treatment for advanced/metastatic gastric cancer or GEJ cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 12 months
Awards & highlights

Study Summary

This trial will study the effects of futibatinib on patients with various cancers caused by aberrant FGFR genes.

Who is the study for?
This trial is for adults with advanced solid tumors, gastric or gastro-esophageal junction cancer, and certain blood cancers that have specific FGFR genetic changes. Participants must have measurable disease and should have tried standard treatments without success. They can't join if they've had prior FGFR inhibitor treatment or significant eye, mineral balance disorders, or unstable brain metastases.Check my eligibility
What is being tested?
The study tests the drug Futibatinib's effectiveness and safety in three groups: those with solid tumors (excluding primary brain tumors) having FGFR1-4 rearrangements; those with gastric cancer with FGFR2 amplification; and blood cancers with FGFR1 rearrangements.See study design
What are the potential side effects?
Potential side effects of Futibatinib may include issues affecting eyesight due to retinal or corneal problems, abnormal mineralization which could affect soft tissues including kidneys and lungs, as well as other common drug-related adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had at least 2 treatments for my advanced cancer.
Select...
My stomach or GEJ cancer worsened after the last treatment.
Select...
My cancer has returned or worsened after standard treatment.
Select...
My cancer is a type of blood cancer with a specific genetic change.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer is advanced or has spread, and tests show FGFR1-4 changes.
Select...
My cancer in the stomach or gastroesophageal junction is advanced and has a specific genetic feature (FGFR2 amplification).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete response (CR) rate in Cohort C
Objective response rate (ORR) in Cohorts A and B
Secondary outcome measures
CR+CRi rate in Cohort C
Complete cytogenetic response (CCyR) rate in Cohort C.
Disease control rate (DCR) in Cohort A and B
+10 more

Side effects data

From 2021 Phase 1 & 2 trial • 407 Patients • NCT02052778
86%
Hyperphosphataemia
50%
Diarrhoea
50%
Constipation
43%
Alanine aminotransferase increased
36%
Nausea
36%
Aspartate aminotransferase increased
36%
Vomiting
21%
Dysgeusia
21%
Dry mouth
21%
Stomatitis
21%
Decreased appetite
21%
Alopecia
21%
Anaemia
14%
Dry eye
14%
Blood bilirubin increased
14%
Asthenia
14%
Dry skin
14%
Gastrooesophageal reflux disease
14%
Paraesthesia
14%
Fatigue
14%
Cough
14%
Nail disorder
14%
Abdominal distension
7%
Palmar-plantar erythrodysaesthesia syndrome
7%
Vaginal haemorrhage
7%
Burn oesophageal
7%
Gastroenteritis viral
7%
Ovarian vein thrombosis
7%
Colonic pseudo-obstruction
7%
Neutropenia
7%
Thrombocytopenia
7%
Cellulitis
7%
Arthralgia
7%
Pyrexia
7%
Confusional state
7%
Back pain
7%
Oral pain
7%
Blood creatinine increased
7%
Insomnia
7%
Pulmonary embolism
7%
Nervous system disorder
7%
Hypoalbuminaemia
7%
Neck pain
7%
Bronchitis viral
7%
Epistaxis
7%
Neuropathy peripheral
7%
Accidental overdose
7%
Dizziness
7%
Electrocardiogram ST segment abnormal
7%
Onychoclasis
7%
Muscle spasms
7%
Oedema peripheral
7%
Upper respiratory tract infection
7%
Conjunctivitis
7%
Vision blurred
7%
Onycholysis
7%
Abdominal pain
7%
Dyspnoea exertional
7%
Hypomagnesaemia
7%
Xerosis
7%
Spinal cord compression
7%
Musculoskeletal stiffness
7%
Onychalgia
7%
Nasal dryness
7%
Skin exfoliation
7%
Sinus tachycardia
7%
Electrocardiogram QT prolonged
7%
Aphasia
7%
Nail ridging
7%
Gingival oedema
7%
Disease progression
7%
Nasopharyngitis
7%
Musculoskeletal pain
7%
Proctitis
7%
Migraine with aura
7%
Pain in extremity
7%
Weight decreased
7%
Blood alkaline phosphatase increased
7%
Hyponatraemia
7%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1: Dose Escalation: QD Dosing: 24 mg
Phase 2
Phase 1: Dose Escalation: QD Dosing: 20 mg
Phase 1: Dose Expansion Cohort 1
Phase 1: Dose Expansion: Cohort 3
Phase 1: Dose Expansion: Cohort 4
Phase 1: Dose Escalation: QOD Dosing: 24 mg
Phase 1: Dose Escalation: QOD Dosing: 56 mg
Phase 1: Dose Escalation: QOD Dosing: 16 mg
Phase 1: Dose Escalation: QOD Dosing: 8 mg
Phase 1: Dose Escalation: QOD Dosing: 120 mg
Phase 1: Dose Escalation: QD Dosing: 8 mg
Phase 1: Dose Expansion: Cohort 6
Phase 1: Dose Expansion: Sub-cohort 2
Phase 1: Dose Expansion: Sub-cohort 1
Phase 1: Dose Escalation: QOD Dosing: 36 mg
Phase 1: Dose Escalation: QOD Dosing: 200 mg
Phase 1: Dose Escalation: QD Dosing: 4 mg
Phase 1: Dose Expansion: Cohort 5
Phase 1: Dose Expansion: Cohort 2
Phase 1: Dose Escalation: QOD Dosing: 80 mg
Phase 1: Dose Escalation: QOD Dosing: 160 mg
Phase 1: Dose Escalation: QD Dosing: 16 mg

Trial Design

3Treatment groups
Experimental Treatment
Group I: Futibatinib (Cohort C)Experimental Treatment1 Intervention
Myeloid or lymphoid neoplasm harboring FGFR1 rearrangement
Group II: Futibatinib (Cohort B)Experimental Treatment1 Intervention
Advanced or metastatic solid gastric or GEJ cancer harboring FGFR2 amplification
Group III: Futibatinib (Cohort A)Experimental Treatment1 Intervention
Advanced or metastatic solid tumors harboring FGFR1-4 rearrangements
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Futibatinib
2014
Completed Phase 2
~410

Find a Location

Who is running the clinical trial?

Taiho Oncology, Inc.Lead Sponsor
66 Previous Clinical Trials
11,429 Total Patients Enrolled

Media Library

Futibatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04189445 — Phase 2
Gastric Cancer Research Study Groups: Futibatinib (Cohort B), Futibatinib (Cohort A), Futibatinib (Cohort C)
Gastric Cancer Clinical Trial 2023: Futibatinib Highlights & Side Effects. Trial Name: NCT04189445 — Phase 2
Futibatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04189445 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the number of people receiving treatment in this experiment?

"Recruitment for this trial has been concluded. It was posted on August 24th 2020 and last updated on October 20th 2022. Those searching for alternative studies may find that there are presently 2387 trials enrolling those with gastroesophageal reflux disease, as well as 8 selection processes involving Futibatinib."

Answered by AI

Is this a pioneering endeavor in its field?

"Presently, 8 ongoing clinical studies for Futibatinib span 24 different nations and 105 cities. This drug's initial trial was conducted in 2019 by Taiho Oncology Inc., with 168 participants completing the Phase 2 testing phase. Since then, zero subsequent studies have been executed."

Answered by AI

What other experiments have researchers conducted with Futibatinib?

"At present, there are 8 ongoing studies exploring the application of Futibatinib with 2 trials reaching Phase 3. While most of these clinical tests are centered in Porto, Tennessee, over 250 other sites across the world have opened their doors to trial participants."

Answered by AI

What potential hazards have been identified with the use of Futibatinib?

"Our team at Power allocated a rating of 2 to futibatinib's safety, as the medication has only been through Phase II trials and there is no clinical data that proves its efficacy."

Answered by AI

What aims is this experiment endeavoring to achieve?

"Per the trial sponsor, Taiho Oncology Inc., this clinical study seeks to measure its primary outcomes -Overall Clinical Benefit Rate (CBR) in Cohort C- over a 6 month timeframe. Additionally, it will gauge secondary objectives such as Overall Survival (OS) across Cohorts A, B and C, Relapse Free Survival (RFS) among Cohort C patients, and Disease Control Rates (DCRs) amongst participants of both Cohort A & B."

Answered by AI

How many medical facilities are conducting this experimental research?

"Currently, 15 locations are administering this clinical trial. These sites span from Washington to Dallas and Auburn in addition to many other cities. It is recommended that participants select the closest site for their convenience and reduce travel obligations."

Answered by AI

Are there any enrollees being sought for this experiment at the moment?

"Currently, this clinical trial is not enrolling candidates. Initially posted on the 24th of August 2020 and last updated on October 20th 2022, participants are encouraged to look into other studies related to gastroesophageal reflux disease as there are currently 2387 trials recruiting patients. Additionally, 8 trials for Futibatinib have open enrollment too."

Answered by AI

Who else is applying?

What site did they apply to?
University of Chicago Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
~7 spots leftby Sep 2024