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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (Complete or Partial Response) Assessed by RECIST 1.1