Infigratinib for Solid Tumors

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sameek Roychowdhury

Must not be taking: CYP3A4 inducers/inhibitors, QT prolonging drugs

Disqualifiers: CNS cancer, Corneal disorder, Cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 6 cycles (approximately 24 weeks)

17 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop all current medications, but you cannot take certain drugs that affect liver enzymes (CYP3A4), increase calcium or phosphorus levels, or prolong the QT interval (a heart rhythm measure). You should discuss your current medications with the trial team to see if any need to be adjusted.

How is the drug Infigratinib unique for treating solid tumors?

Infigratinib is unique because it specifically targets and inhibits fibroblast growth factor receptors (FGFRs), which are involved in the growth of certain tumors. This makes it particularly effective for tumors with FGFR alterations, offering a targeted approach compared to traditional chemotherapy. ^{1 2 3 4 5}

Research Team

Sameek Roychowdhury, M.D.

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors that have specific FGFR gene mutations. Participants must have tried at least one standard treatment and still show signs of the disease, be able to swallow pills, and comply with study procedures. People can't join if they have primary brain cancer or untreated brain metastases, severe eye disorders, significant tissue calcification, gastrointestinal issues affecting drug absorption, abnormal calcium/phosphate metabolism, recent use of certain drugs including strong CYP3A4 inhibitors/inducers or those prolonging QT interval.

Inclusion Criteria

Evidence of measurable or evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

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, Willing and able to comply with scheduled visits, treatment plan and laboratory tests

Exclusion Criteria

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive infigratinib orally once daily on days 1-21 of each 28-day cycle

6 cycles (approximately 24 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 1 year post-treatment

Every 8 weeks until disease progression, then every 4 months for 1 year

Treatment Details

Interventions

• Infigratinib

Trial Overview The trial tests Infigratinib's effectiveness on patients with advanced solid tumors harboring FGFR gene mutations. It aims to see if this oral medication can stop tumor growth by inhibiting over-active FGFR proteins caused by these genetic changes.

Participant Groups

Group I: Treatment (infigratinib) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Sameek Roychowdhury

Lead Sponsor

Trials

3

Recruited

40+

References

1. United States pubmed.ncbi.nlm.nih.gov

Infigratinib Mediates Vascular Normalization, Impairs Metastasis, and Improves Chemotherapy in Hepatocellular Carcinoma. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Hyperphosphatemia Secondary to the Selective Fibroblast Growth Factor Receptor 1-3 Inhibitor Infigratinib (BGJ398) Is Associated with Antitumor Efficacy in Fibroblast Growth Factor Receptor 3-altered Advanced/Metastatic Urothelial Carcinoma. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacovigilance Study of Infigratinib: A Safety Analysis of the FDA Adverse Event Reporting System. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Infigratinib: First Approval. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Infigratinib in upper tract urothelial carcinoma versus urothelial carcinoma of the bladder and its association with comprehensive genomic profiling and/or cell-free DNA results. [2021]