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 ]
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