Clinical Trial: Pan FGFR Kinase Inhibitor BGJ398 in Treating Patients With FGFR1-3 Translocated, Mutated, or Amplified Recurrent Head and Neck Cancer

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief Summary: This phase IIa trial studies how well pan fibroblast growth factor receptor (FGFR) kinase inhibitor BGJ398 works in treating patients with FGFR1-3 translocated, mutated, or amplified head and neck cancer that has returned after a period of improvement. Pan FGFR kinase inhibitor BGJ398 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Summary:

PRIMARY OBJECTIVES:

I. Assess efficacy of pan FGFR kinase inhibitor BGJ398 (BGJ398) in FGFR altered human papillomavirus (HPV) negative (-) and HPV positive (+) head and neck squamous cell carcinoma (HNSCC).

SECONDARY OBJECTIVES:

I. Assess efficacy of BGJ398 in relation to specific genetic aberrations in HPV (+) and HPV (-) FGFR altered HNSCC (i.e. FGFR3-transforming, acidic, coiled-coil-containing protein 3 [TACC3] translocation, FGFR1 high copy number/amplification, FGFR2 mutation, FGFR3 mutation).

II. Assess safety and tolerability of BGJ398 in patients with head and neck cancer.

III. Assess progression free and overall survival.

TERTIARY OBJECTIVES:

I. Determine mechanisms of resistance to FGFR inhibition at disease progression.

OUTLINE:

Patients receive pan FGFR kinase inhibitor BGJ398 orally (PO) once daily (QD) on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 1-3 months for 5 years.


Sponsor: University of Chicago

Current Primary Outcome: Objective response rate (complete or partial response) assessed by RECIST 1.1 [ Time Frame: Up to 5 years ]

Original Primary Outcome: Response rate in HPV(+) and HPV (-) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]

Assessed through RECIST 1.1


Current Secondary Outcome:

  • Incidence of adverse events and serious adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 5 years ]
  • Overall survival [ Time Frame: Up to 5 years ]
  • Progression-free survival [ Time Frame: Up to 5 years ]
  • Response rate in subgroups of patients defined by certain genetic changes in FGFR1-3 assessed by RECIST 1.1 [ Time Frame: Up to 5 years ]


Original Secondary Outcome:

  • Response rate in specific genetic aberrations [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]
    Assessed through RECIST 1.1
  • Incidence of adverse events (safety and tolerability) [ Time Frame: From date of randomization until 5 years post treatment or death, whichever occurs first ]
    Measured by monitoring adverse events and significant adverse events
  • Progression-free survival [ Time Frame: From randomization until 5 years post treatment or death, whichever occurs first ]
    Measured in days date of progression or death (if no earlier progression) minus date of randomization +1
  • Overall survival [ Time Frame: From randomization until 5 years post treatment or death, whichever occurs first ]
    Measured in days from date of death minus date of randomization +1


Information By: University of Chicago

Dates:
Date Received: March 1, 2016
Date Started: June 2017
Date Completion: June 2018
Last Updated: April 18, 2017
Last Verified: April 2017