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Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

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Neoplasms, Squamous Cell

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All Drugs and Chemicals

Infigratinib

Patients receive BGJ398 (125 mg) by mouth once daily on a three weeks on, one week off schedule. Courses repeat every 28 days until disease progression or unacceptable toxicity.

BGJ398

Tanguy Seiwert

This phase IIa trial studies how well the experimental drug, BGJ398 (infigratinib), works in treating patients with fibroblast growth factor receptor (FGFR) 1-3 translocated, mutated, or amplified head and neck cancer that has returned after a period of improvement. BGJ398 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

BGJ398 in Treating Patients With FGFR Positive Recurrent Head and Neck Cancer

Phase IIa Study of the Efficacy of Single Agent BGJ398 (Infigratinib) in FGFR1-3 Translocated, Mutated, or Amplified Squamous Cell Carcinoma of the Head and Neck

Novartis

University of Chicago

Patients receive BGJ398 (125 mg) by mouth once daily on a three weeks on, one week off schedule. Courses repeat every 28 days until disease progression or unacceptable toxicity.

BGJ398: Given by mouth (oral)

BGJ398 (Infigratinib) Dosing

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Study stopped enrollment due to poor accrual. Outcomes measures could not be analyzed due to lack of enrollment.

Technical Director

Study stopped after 1 patient enrolled. Endpoint could not be analyzed.

Objective Response Rate (Complete or Partial Response) Assessed by RECIST 1.1

Incidence of Adverse Events and Serious Adverse Events Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

Overall Survival

Progression-free Survival

Overall Study

Spots Global Cancer Trial Database for fgfr gene amplification