Infigratinib for Solid Tumors

Recruiting in Palo Alto (17 mi)

Overseen bySameek Roychowdhury, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sameek Roychowdhury

No Placebo Group

Prior Safety Data

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.

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

+5 more

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

+6 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Treatment (infigratinib)Experimental Treatment1 Intervention

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