What side effects are associated with this type of intervention?

Common treatments for gastric cancer, particularly those involving FGFR inhibitors like Futibatinib, often include targeted therapies and chemotherapy. The known side effects of FGFR inhibitors can include hyperphosphatemia, fatigue, diarrhea, and skin toxicities. Chemotherapy regimens, which may be used in combination with targeted therapies, commonly cause nausea, vomiting, neutropenia, and neuropathy. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

FDA-approved treatments for gastric cancer include a variety of targeted therapies and chemotherapeutic agents. Notably, ramucirumab, a VEGFR2 antagonist, has been approved for use in combination with paclitaxel or as monotherapy for advanced gastric or gastroesophageal junction adenocarcinoma. Additionally, trastuzumab, a monoclonal antibody targeting HER2, is approved for HER2-positive gastric cancer. While specific FGFR inhibitors like Futibatinib are still under investigation, these approvals highlight the ongoing efforts to target specific molecular pathways in the treatment of gastric cancer.

What other types of research exist?

Promising novel alternatives to Futibatinib for gastric cancer patients include: 1) Lapatinib, a dual tyrosine kinase inhibitor targeting EGFR and HER2, which has shown efficacy in various cancers. 2) Bevacizumab, an anti-VEGF monoclonal antibody, which has been effective in combination therapies for different types of cancer. 3) Erlotinib, an EGFR inhibitor, which has demonstrated activity in several solid tumors. These agents represent potential alternatives based on their mechanisms and clinical trial outcomes.

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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

Must not have

Prior treatment with an FGFR inhibitor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing futibatinib, an oral medication, in patients with specific genetic changes in their cancer. It aims to block proteins that help cancer grow, targeting those who may not respond well to typical treatments. Futibatinib has shown selective antitumor activity in various tumors.

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.

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.

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.

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My stomach or GEJ cancer worsened after the last treatment.

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My cancer has returned or worsened after standard treatment.

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My cancer is a type of blood cancer with a specific genetic change.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer is advanced or has spread, and tests show FGFR1-4 changes.

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My cancer in the stomach or gastroesophageal junction is advanced and has a specific genetic feature (FGFR2 amplification).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been treated with an FGFR inhibitor before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete response (CR) rate in Cohort C

Objective response rate (ORR) in Cohorts A and B

Secondary study objectives

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

88%

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%

Anaemia

12%

Hypoaesthesia

12%

Dry mouth

12%

Nausea

12%

Hemiparesis

12%

Muscular weakness

Muscle spasms

Oropharyngeal pain

Dyspepsia

Blood alkaline phosphatase increased

Gamma-glutamyltransferase increased

Weight increased

Stomatitis

Arthralgia

Weight decreased

Ageusia

Conjunctivitis

Palmar-plantar erythrodysaesthesia syndrome

Insomnia

Hiccups

Blood creatinine increased

Hypokalaemia

Hypercalcaemia

Lymphocyte count decreased

Urinary retention

Bronchitis

Platelet count decreased

Phlebitis

Abdominal pain upper

Lymphopenia

Dry skin

Pain

Dizziness

Vertigo

Mucosal dryness

Back pain

Mouth ulceration

Urinary tract infection

Hypophosphataemia

Pain in extremity

Dysgeusia

Seizure

Confusional state

Rash maculo-papular

Blood bilirubin increased

Gastrooesophageal reflux disease

Dysphagia

Paronychia

Hyperuricaemia

Hyponatraemia

Memory impairment

Hyperkalaemia

Onychalgia

Nail discolouration

Thrombocytopenia

Gait disturbance

Blood calcium increased

Musculoskeletal pain

Paraesthesia

Epistaxis

Pulmonary thrombosis

White blood cell count decreased

Hyperglycaemia

Tremor

Hypotension

Vulvovaginal dryness

Nasal congestion

Pruritus

Ventricular tachycardia

Disorientation

Onycholysis

Intracranial mass

Rectal haemorrhage

Swelling face

Onychomadesis

General physical health deterioration

Blood phosphorus increased

Proteinuria

Rash

Pharyngitis

Mental status changes

Tinnitus

Balance disorder

Dyspnoea

Deep vein thrombosis

Nuclear magnetic resonance imaging brain abnormal

Subarachnoid haemorrhage

Abdominal discomfort

Flatulence

Neutrophil count decreased

100%

80%

60%

40%

20%

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

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

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Gastric cancer treatments often target specific molecular pathways involved in tumor growth and progression. FGFR inhibitors, such as futibatinib, work by blocking the fibroblast growth factor receptors (FGFRs) that are often overexpressed or mutated in certain cancers, including gastric cancer. By inhibiting these receptors, FGFR inhibitors can reduce tumor cell proliferation and survival. This is particularly important for gastric cancer patients with FGFR2 amplification, as targeting this pathway can potentially lead to more effective and personalized treatment options, improving outcomes and reducing side effects compared to traditional chemotherapy.

Stress Granules in the Anti-Cancer Medications Mechanism of Action: A Systematic Scoping Review.Disparity between Inter-Patient Molecular Heterogeneity and Repertoires of Target Drugs Used for Different Types of Cancer in Clinical Oncology.New and emerging combination therapies for esophageal cancer.