Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations

NCT04233567 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: OSU-19041NCI-2019-06869
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well infigratinib works in treating solid tumors that have spread to other places in the body (advanced or metastatic) in patients with FGFR gene mutations such as FGFR1-3 gene fusions or other FGFR genetic alterations. Mutations are any changes in the genetic material (DNA) of a cell. FGFR proteins are involved in cell division, cell maturation, formation of new blood vessels, wound healing, and bone growth, development, and maintenance. FGFR mutations can cause the FGFR protein to become over-active in diseases such as cancer. Infigratinib may stop the growth of tumor cells by blocking FGFR proteins in these tumors.

Conditions

Advanced Malignant Solid Neoplasm; Cholangiocarcinoma; Metastatic Malignant Solid Neoplasm; Refractory Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Assessed by investigator as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. The estimated ORR will be presented along with the corresponding 90% confidence interval for each cohort, based on a binomial distribution. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all non-nodal target lesions; Partial Response (PR), at least a 30% decrease in the sum of diameter of all target lesions; Overall Response (OR) = CR + PR

  6 cycles of treatment (each cycle is 28 days) or upon treatment discontinuation

Secondary Outcomes (4)

• Progression Free Survival (PFS)

  From start of treatment to the date of the event defined as the first documented progression or death due to any cause, assessed up to 1 year post-treatment, up to 5 years

• Disease Control Rate

  Up to 1 year post-treatment, up to 5 years

• Overall Survival (OS)

  From the date of start of treatment to the date of death due to any cause, will be assessed at 4, 6, 8,12 and 24 months

• Frequency of Adverse Events (AEs)

  Up to 30 days post-treatment, up to 5 years

Study Arms (1)

Treatment (infigratinib)

EXPERIMENTAL

Patients receive infigratinib PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: Infigratinib

Interventions

Infigratinib DRUG

Given PO

Also known as: 3-(2,6-Dichloro-3,5-dimethoxyphenyl)-1-(6-((4-(4-ethylpiperazin-1-yl)phenyl)amino)pyrimidin-4-yl)-1-methylurea, BGJ-398, BGJ398

Treatment (infigratinib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically or cytologically confirmed advanced or metastatic solid tumors of any histologic classification at the time of diagnosis
• Written documentation of local or central Clinical Laboratory Improvement Act (CLIA)-certified laboratory determination of FGFR gene fusions/translocations or activating mutations
• The study is open to solid tumors in the following cohorts:
• Cohort 1: Solid tumor patients with FGFR1-3 fusion/translocation (n=10) who have progressed on or are intolerant to standard of care (SOC) therapies and received treatment with a different FGFR inhibitor. Cholangiocarcinoma patients are permitted in this cohort
• Cohort 2: Solid tumor patients with FGFR1-3 fusion/translocation (n, up to 30) who have progressed on or are intolerant to SOC therapies. Prior therapy with a different FGFR inhibitor is not permitted. Cholangiocarcinoma patients are excluded from this cohort (there are multiple competing studies and opportunities for patients to get treatment in other trials)
• Cohort 3: Solid tumor patients with genetic alterations such as point mutations, insertions/deletions, or amplifications in any FGFR gene family member (n=10). Prior therapy with a different FGFR inhibitor is not permitted. Cholangiocarcinoma patients are permitted in this cohort
• Evidence of measurable or evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• Patients must have received at least one prior SOC regimen for advanced/metastatic cancer. Patient should have had evidence of progressive disease following their prior regimen, or if prior treatment was discontinued due to toxicity must have continued evidence of measurable or evaluable disease. Patients who have received prior treatment with an alternate FGFR inhibitor are still eligible for the study
• Patients with primary central nervous system (CNS) cancer or CNS metastases are excluded (because it is unclear how much CNS penetration the drug has). However, asymptomatic patients with history of successfully treated CNS metastases with surgery or radiation and follow up imaging showing stability, can be eligible
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (patients with ECOG performance status of 2 may be considered on a case-by-case basis after discussion with QED Therapeutics)
• Able to read and/or understand the details of the study and provide written evidence of informed consent as approved by Institutional Review Board (IRB)/Ethics Committee (EC)
• Recovery from adverse events of previous systemic anti-cancer therapies to baseline or grade 1, except for:
• Alopecia
• Stable neuropathy of =\< grade 2 due to prior cancer therapy
• Able to swallow and retain oral medication

You may not qualify if:

• Patients who have therapies available that are known to confer a clinical benefit will be excluded from the study
• Neurological symptoms related to underlying disease requiring increasing doses of corticosteroids. Note: Steroid use for management of CNS tumors is allowed but must be at a stable dose for at least 2 weeks preceding study entry
• History of another primary malignancy except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin or any other curatively treated malignancy that is not expected to require treatment for recurrence during the course of the study or affect survival
• Any other medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures
• Current evidence of corneal or retinal disorder/keratopathy including, but not limited to, bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis, confirmed by ophthalmologic examination
• History and/or current evidence of extensive tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium and lung with the exception of calcified lymph nodes, minor pulmonary parenchymal calcifications, and asymptomatic coronary calcification
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral infigratinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)
• Current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis etc
• Treatment with any of the following anti-cancer therapies prior to the first dose of infigratinib within the stated timeframes:
• Cyclical chemotherapy (intravenous) within a period of time that is shorter than the cycle length used for that treatment (e.g., 6 weeks for nitrosourea, mitomycin-C)
• Biological therapy (e.g., antibodies - including bevacizumab) within a period of time that is =\< 5 half-life (t1/2) or =\< 4 weeks, whichever is shorter, prior to starting study drug
• Continuous or intermittent small molecule therapeutics within a period of time that is =\< 5 t1/2 or =\< 4 weeks (whichever is shorter) prior to starting study drug
• Any other investigational agents within a period of time that is =\< 5 t1/2 or less than the cycle length used for that treatment or =\< 4 weeks (whichever is shortest) prior to starting study drug
• Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) =\< 4 weeks or limited field radiation for palliation =\< 2 weeks prior to starting study drug
• Patients who are currently receiving treatment with agents that are known strong inducers or inhibitors of CYP3A4 and medications which increase serum phosphorus and/or calcium concentration are excluded. Patients are not permitted to receive enzyme-inducing anti-epileptic drugs

Sponsors & Collaborators

• Sameek Roychowdhury: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Cholangiocarcinoma; Neoplasm Metastasis

Interventions

infigratinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Sameek Roychowdhury
• Organization: The Ohio State University Comprehensive Cancer Center

Sameek.Roychowdhury@osumc.edu

614-685-5842

Study Officials

• Sameek Roychowdhury, M.D.

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: January 16, 2020
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2024
• Last Updated: February 24, 2026
• Results First Posted: June 10, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)