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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 12 months
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 moreSide effects data
From 2021 Phase 1 & 2 trial • 407 Patients • NCT0205277885%
Hyperphosphataemia
39%
Constipation
36%
Diarrhoea
35%
Dry mouth
35%
Fatigue
34%
Alopecia
29%
Dry skin
25%
Aspartate aminotransferase increased
24%
Nausea
24%
Stomatitis
22%
Decreased appetite
22%
Dry eye
22%
Arthralgia
21%
Palmar-plantar erythrodysaesthesia syndrome
20%
Dysgeusia
20%
Abdominal pain
19%
Vomiting
19%
Urinary tract infection
18%
Weight decreased
17%
Back pain
17%
Anaemia
17%
Alanine aminotransferase increased
17%
Hyponatraemia
16%
Nail disorder
16%
Hypercalcaemia
16%
Onycholysis
15%
Muscle spasms
15%
Blood creatinine increased
15%
Myalgia
15%
Oedema peripheral
15%
Onychomadesis
14%
Hypophosphataemia
14%
Nail discolouration
13%
Blood alkaline phosphatase increased
12%
Thrombocytopenia
11%
Pyrexia
10%
Peripheral sensory neuropathy
10%
Blood creatine phosphokinase increased
10%
Oropharyngeal pain
10%
Dizziness
9%
Blood phosphorus increased
9%
Pain in extremity
9%
Pruritus
8%
Headache
8%
Vision blurred
8%
Abdominal pain upper
8%
Insomnia
8%
Paronychia
7%
Blood bilirubin increased
7%
Dyspepsia
7%
Upper respiratory tract infection
7%
Hypoaesthesia
7%
Troponin T increased
7%
Epistaxis
6%
Cataract
6%
Dehydration
6%
Lacrimation increased
6%
Abdominal distension
6%
Hypokalaemia
6%
Gastrooesophageal reflux disease
6%
Musculoskeletal pain
6%
Neuropathy peripheral
6%
Hypertension
6%
Hypoalbuminaemia
6%
White blood cell count decreased
6%
Neutrophil count decreased
5%
Disease progression
5%
Confusional state
5%
Paraesthesia
5%
Tumour pain
5%
Dysphagia
5%
Dysuria
5%
Rash
4%
Nasal congestion
4%
Ascites
4%
Lymphopenia
4%
Asthenia
4%
Chills
4%
Cough
4%
Dyspnoea
4%
Hyperglycaemia
4%
Taste disorder
4%
Neutropenia
4%
Non-cardiac chest pain
4%
Lymphocyte count decreased
4%
Hypotension
4%
Visual impairment
4%
Mouth ulceration
3%
Subretinal fluid
3%
Eye pain
3%
Hyperkalaemia
3%
Hiccups
3%
Bile duct obstruction
3%
Hyperbilirubinaemia
3%
Activated partial thromboplastin time prolonged
3%
Tremor
3%
Platelet count decreased
3%
Oral pain
3%
Pain
3%
Hypomagnesaemia
3%
Conjunctivitis
3%
Onychalgia
3%
Upper gastrointestinal haemorrhage
2%
Lung infection
2%
Sepsis
2%
Oral candidiasis
2%
Peripheral swelling
2%
Vertigo
2%
Trichiasis
2%
Sinusitis
2%
Weight increased
2%
Fall
2%
Transient ischaemic attack
2%
Cellulitis
2%
Migraine
2%
Tachycardia
2%
Skin papilloma
2%
International normalised ratio increased
2%
Hypocalcaemia
2%
Punctate keratitis
2%
Cystitis
2%
Muscular weakness
2%
Haematuria
2%
Overdose
2%
Pharyngitis
2%
Musculoskeletal chest pain
2%
Erythema
2%
Chorioretinopathy
2%
Gamma-glutamyltransferase increased
2%
Anxiety
2%
Pneumothorax
2%
Rash maculo-papular
1%
Corona virus infection
1%
Appendicitis
1%
Peritonitis bacterial
1%
Bacteraemia
1%
Humerus fracture
1%
Muscle strain
1%
Cognitive disorder
1%
Oncologic complication
1%
Haemorrhoids
1%
Blood calcium increased
1%
Intestinal obstruction
1%
Bone pain
1%
Neck pain
1%
Device related infection
1%
Splenic abscess
1%
Hepatic encephalopathy
1%
Infection
1%
Focal dyscognitive seizures
1%
Pneumonia
1%
Hypertrichosis
1%
Gastrointestinal haemorrhage
1%
Oesophagitis
1%
Umbilical hernia
1%
Peritonitis
1%
Hypoglycaemia
1%
Urinary retention
1%
Aphasia
1%
Hypoacusis
1%
Abdominal discomfort
1%
Rectal haemorrhage
1%
Joint swelling
1%
Growth of eyelashes
1%
Keratitis
1%
Tinnitus
1%
Ocular hyperaemia
1%
Memory impairment
1%
Procedural pain
1%
Proteinuria
1%
Guillain-Barre syndrome
1%
Urine analysis abnormal
1%
Pneumonitis
1%
Pollakiuria
1%
Ageusia
1%
Acute kidney injury
1%
Blister
1%
Oesophageal varices haemorrhage
1%
Impaired gastric emptying
1%
Cholangitis
1%
Biliary tract infection
1%
Wound infection
1%
Malignant ascites
1%
Malignant pleural effusion
1%
Tumour associated fever
1%
Extrapyramidal disorder
1%
Otitis media
1%
Vulvovaginal mycotic infection
1%
Pelvic pain
1%
Dysphonia
1%
Femur fracture
1%
Rib fracture
1%
Metastases to central nervous system
1%
Influenza like illness
1%
Cancer pain
1%
Upper-airway cough syndrome
1%
Nail hypertrophy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2
Phase 1: Dose Escalation: QD Dosing: 20 mg
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: 8 mg
Phase 1: Dose Expansion Cohort 1
Phase 1: Dose Escalation: QOD Dosing: 120 mg
Phase 1: Dose Escalation: QOD Dosing: 8 mg
Phase 1: Dose Escalation: QOD Dosing: 24 mg
Phase 1: Dose Expansion: Cohort 3
Phase 1: Dose Escalation: QOD Dosing: 16 mg
Phase 1: Dose Escalation: QD Dosing: 4 mg
Phase 1: Dose Escalation: QD Dosing: 24 mg
Phase 1: Dose Expansion: Cohort 2
Phase 1: Dose Expansion: Cohort 4
Phase 1: Dose Expansion: Cohort 5
Phase 1: Dose Expansion: Sub-cohort 2
Phase 1: Dose Escalation: QOD Dosing: 56 mg
Phase 1: Dose Expansion: Cohort 6
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
11,469 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain metastases are either untreated or not stable for over a month.I have had at least 2 treatments for my advanced cancer.I cannot have a stem cell transplant or it didn't work for me, and no other treatments are suitable.My stomach or GEJ cancer worsened after the last treatment.My cancer has returned or worsened after standard treatment.My cancer is a type of blood cancer with a specific genetic change.My cancer has a specific FGFR gene change.I am fully active or restricted in physically strenuous activity but can do light work.You have a medical condition related to the balance of calcium and phosphorus in your body that the doctor considers important.My cancer is advanced or has spread, and tests show FGFR1-4 changes.My cancer in the stomach or gastroesophageal junction is advanced and has a specific genetic feature (FGFR2 amplification).I have been treated with an FGFR inhibitor before.I have abnormal mineral deposits in organs like the heart or lungs, considered significant by my doctor.I have a history of certain health disorders.
Research Study Groups:
This trial has the following groups:- Group 1: Futibatinib (Cohort B)
- Group 2: Futibatinib (Cohort A)
- Group 3: Futibatinib (Cohort C)
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.
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
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