Trials / Terminated
TerminatedNCT02706691
BGJ398 in Treating Patients With FGFR Positive Recurrent Head and Neck Cancer
Phase IIa Study of the Efficacy of Single Agent BGJ398 (Infigratinib) in FGFR1-3 Translocated, Mutated, or Amplified Squamous Cell Carcinoma of the Head and Neck
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- University of Chicago · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | BGJ398 | Given by mouth (oral) |
Timeline
- Start date
- 2018-06-01
- Primary completion
- 2019-02-11
- Completion
- 2019-02-11
- First posted
- 2016-03-11
- Last updated
- 2019-04-16
- Results posted
- 2019-04-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02706691. Inclusion in this directory is not an endorsement.