NCT02706691 is a Phase 2 clinical trial of BGJ398 in FGFR Gene Amplification, sponsored by University of Chicago.

Who is sponsoring NCT02706691?

NCT02706691 is sponsored by University of Chicago.

What drugs are being tested in NCT02706691?

Interventions in NCT02706691: BGJ398.

What condition does NCT02706691 study?

NCT02706691 studies 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.

Is NCT02706691 still recruiting?

NCT02706691 is currently terminated. Last updated 16 April 2019.

Are results published for NCT02706691?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-04-16 · How we verify

NCT02706691

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

BGJ398 in Treating Patients With FGFR Positive Recurrent Head and Neck Cancer

Terminated Phase 2 Results posted Last updated 16 April 2019

What this trial tests

Phase 2 trial testing BGJ398 in FGFR Gene Amplification in 1 participant. Terminated before completion.

Timeline

1 June 2018

Primary endpoint
11 February 2019

11 February 2019

Quick facts

Lead sponsor	University of Chicago
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	1 June 2018
Primary completion	11 February 2019
Estimated completion	11 February 2019
Sites	1 location across United States

Drugs / interventions tested

BGJ398 — full drug profile →

Conditions studied

FGFR Gene Amplification — all drugs for FGFR Gene Amplification →
FGFR1 Gene Amplification — all drugs for FGFR1 Gene Amplification →
FGFR2 Gene Amplification — all drugs for FGFR2 Gene Amplification →
FGFR2 Gene Mutation — all drugs for FGFR2 Gene Mutation →

Sponsor

University of Chicago

Who can join

18 and older, any sex, with FGFR Gene Amplification or FGFR1 Gene Amplification. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events collected over entire treatment period (2 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BGJ398 (Infigratinib) Dosing

Serious: 1/1 (100%)

Deaths: 1/1

Serious adverse events (1 terms)

Reaction	System	BGJ398 (Infigratinib) Dosing
Stroke	Nervous system disorders	—

Other adverse events (13 terms — click to expand)

Reaction	System	BGJ398 (Infigratinib) Dosing
Elevated inorganic phosphaste	Investigations	—
Bruising	Injury, poisoning and procedural complications	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Dry mouth	Gastrointestinal disorders	—
Dysphagia	Gastrointestinal disorders	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—
Fatigue	General disorders	—
Tarry Stool	Gastrointestinal disorders	—
Lip Bleeding	Gastrointestinal disorders	—
Bilateral ankle soreness	General disorders	—
Mucositis oral	Gastrointestinal disorders	—
Hand-foot Syndrome	Skin and subcutaneous tissue disorders	—
Tremor	Nervous system disorders	—

Most-reported serious reactions: Stroke.

Data from ClinicalTrials.gov NCT02706691 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Inhibition of the fibroblast growth factor receptor (FGFR) pathway: the current landscape and barriers to clinical application.
Chae YK, Ranganath K, Hammerman PS, Vaklavas C, et al · · 2017 · cited 231× · PMID 28030802 · DOI 10.18632/oncotarget.14109
Fibroblast Growth Factor Receptors (FGFRs): Structures and Small Molecule Inhibitors.
Dai S, Zhou Z, Chen Z, Xu G, et al · · 2019 · cited 206× · PMID 31216761 · DOI 10.3390/cells8060614
FGFR3-TACC3 fusion in solid tumors: mini review.
Costa R, Carneiro BA, Taxter T, Tavora FA, et al · · 2016 · cited 107× · PMID 27409839 · DOI 10.18632/oncotarget.10482
HPV-driven oropharyngeal cancer: current knowledge of molecular biology and mechanisms of carcinogenesis.
Pan C, Issaeva N, Yarbrough WG. · · 2018 · cited 79× · PMID 31093365 · DOI 10.1186/s41199-018-0039-3
Structure, activation and dysregulation of fibroblast growth factor receptor kinases: perspectives for clinical targeting.
Farrell B, Breeze AL. · · 2018 · cited 77× · PMID 30545934 · DOI 10.1042/bst20180004
Clinical Development of Molecular Targeted Therapy in Head and Neck Squamous Cell Carcinoma.
Gougis P, Moreau Bachelard C, Kamal M, Gan HK, et al · · 2019 · cited 39× · PMID 32337482 · DOI 10.1093/jncics/pkz055
Transcriptome analysis of desmoplastic small round cell tumors identifies actionable therapeutic targets: a report from the Children's Oncology Group.
Hingorani P, Dinu V, Zhang X, Lei H, et al · · 2020 · cited 37× · PMID 32703985 · DOI 10.1038/s41598-020-69015-w
Fibroblast growth factor (FGF), FGF receptor (FGFR), and cyclin D1 (CCND1) DNA methylation in head and neck squamous cell carcinomas is associated with transcriptional activity, gene amplification, human papillomavirus (HPV) status, and sensitivity to tyrosine kinase inhibitors.
Bao Y, Gabrielpillai J, Dietrich J, Zarbl R, et al · · 2021 · cited 21× · PMID 34933671 · DOI 10.1186/s13148-021-01212-4

Verify or expand the search:

Other trials of BGJ398

Trials testing the same drug.

NCT03773302 — Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations · Phase 3 · terminated
NCT03510455 — BGJ398 for the Treatment of Tumor-Induced Osteomalacia · Phase 2 · terminated
NCT02657486 — BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder · NA · completed
NCT02257541 — BGJ398 in Combination With Imatinib Mesylate in Patients With Untreated Advanced Gastrointestinal Stromal Tumor (GIST) · Phase 1, PHASE2 · completed
NCT02160041 — BGJ398 for Patients With Tumors With FGFR Genetic Alterations · Phase 2 · terminated

Other University of Chicago trials

Trials by the same sponsor.

NCT07346196 — A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck · Phase 2 · not yet recruiting
NCT07354100 — Lactulose to Improve Gut Health in Cancer Patients Receiving Immunotherapy · Phase 1, PHASE2 · not yet recruiting
NCT06446661 — Using Text Messages to Improve Oral Chemotherapy for Adolescents and Adults With Acute Lymphoblastic Leukemia · NA · not yet recruiting
NCT07179315 — A Study Comparing Two Immunotherapy Options for Human Papillomavirus Positive HPV-Positive Head and Neck Cancer After Tr · Phase 2 · not yet recruiting
NCT07126561 — Trastuzumab Deruxtecan to Treat HER2 + Newly Diagnosed Metastatic GI Cancers · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02706691 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Chicago
Last refreshed: 16 April 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02706691.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing