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

NCT02706691 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-04-16

Study results available
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Summary

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.

Conditions

  • FGFR Gene Amplification
  • FGFR1 Gene Amplification
  • FGFR2 Gene Amplification
  • FGFR2 Gene Mutation
  • FGFR3 Gene Mutation
  • Head and Neck Squamous Cell Carcinoma
  • Human Papillomavirus Infection
  • Recurrent Head and Neck Carcinoma
  • Recurrent Nasopharynx Carcinoma
  • Recurrent Oropharyngeal Squamous Cell Carcinoma

Interventions

DRUG

BGJ398

Given by mouth (oral)

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • University of Chicago

    lead OTHER

Principal Investigators

  • Tanguy Seiwert · University of Chicago Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-02-11
Completion
2019-02-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02706691 on ClinicalTrials.gov