BGJ398 in Treating Patients With FGFR Positive Recurrent Head and Neck Cancer (NCT02706691) | Clinical Trial Compass
TerminatedPhase 2
BGJ398 in Treating Patients With FGFR Positive Recurrent Head and Neck Cancer
Stopped: Study stopped due to poor enrollment.
United States1 participantsStarted 2018-06-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically documented diagnosis of squamous cell carcinoma of the head/neck including nasopharyngeal carcinomas (lymphepithelioma histology is ok if criteria 2 is met)
* Patients must have progressed on prior platinum based therapy (or have become intolerant) prior to enrollment on this study
* Prior anti-PD-1 or other immunotherapy is acceptable
* Known FGFR genetic alterations (specifically FGFR1-3 mutation, amplification, or translocation) via deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) based assay.
* The following genetic aberrations will be screened for:
* FGFR1 amplification, FGFR1 somatic mutations, FGFR1 translocations
* FGFR2 somatic mutations, FGFR2 translocations, FGFR2 amplification
* FGFR3 somatic mutations, FGFR3 translocations, FGFR3 amplification
* Other genetic FGF/FGFR pathway aberrations may be acceptable should such genetic changes be observed to emerge and require approval per the lead investigator for enrollment.
* The number of enrolled patients with each type of genetic aberration may be limited at the discretion of the lead investigator.
* Consent to undergo a fresh biopsy in case of benefit from therapy and subsequent progression
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
* Patients must provide written informed consent prior to any screening procedures
* Aged 18 years or older
* Willing and able to comply with scheduled visits, treatment plan and laboratory tests…
What they're measuring
1
Objective Response Rate (Complete or Partial Response) Assessed by RECIST 1.1