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

NCT02706691 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: IRB14-1447NCI-2016-01121
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (Complete or Partial Response) Assessed by RECIST 1.1

  Up to 5 years

Secondary Outcomes (3)

• Incidence of Adverse Events and Serious Adverse Events Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

  Through 30 days after end of study treatment

• Overall Survival

  Up to 5 years

• Progression-free Survival

  Up to 5 years

Study Arms (1)

BGJ398 (infigratinib) Dosing

EXPERIMENTAL

Patients receive BGJ398 (125 mg) by mouth once daily on a three weeks on, one week off schedule. Courses repeat every 28 days until disease progression or unacceptable toxicity.

Drug: BGJ398

Interventions

BGJ398 DRUG

Given by mouth (oral)

Also known as: infigratinib

BGJ398 (infigratinib) Dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of another primary malignancy except adequately treated in situ carcinoma of the cervix or non-melanoma carcinoma of the skin or any other curatively treated malignancy that has not been treated in the prior 3 months or expected to require treatment for recurrence during the course of the study
• Patients with metastatic central nervous system (CNS) tumors are allowed provided that they are clinically stable for a period of 30 days prior to study entry and there is not a requirement for steroid (other than close to physiologic doses) or anti-convulsant therapy; patients with leptomeningeal involvement are excluded
• Patients who received a prior selective FGFR inhibitor in the recurrent/metastatic disease setting; prior use of a multikinase inhibitor that includes anti-FGFR activity is acceptable after review by the lead investigator
• History and/or current evidence of tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium and lung with the exception of calcified lymph nodes and asymptomatic coronary calcification
• Current evidence of corneal or retinal disorder/keratopathy including, but not limited to, bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjuctivitis, confirmed by ophthalmologic examination
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral BGJ398 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)
• History and/or current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis, etc unless approval from lead investigator/ collaborator is obtained
• Treatment with any of the following anti-cancer therapies prior to the first dose of BGJ398 within the stated timeframes
• Cyclical chemotherapy (intravenous) within a period of 2 weeks unless there are ongoing side effects \> grade 2
• Biological therapy (including small molecules, and/or) within a period of time that is =\< 2 weeks prior to starting study drug unless there are ongoing side effects \> grade 2
• Any other investigational agents within a period =\< 2 weeks prior to starting study drug unless there are ongoing side effects \> grade 2
• Wide field radiotherapy (including radioisotopes) =\< 2 weeks prior to starting study drug unless there are ongoing side effects \> grade 2
• Patients who are currently receiving treatment with agents that are known strong inducers or inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) are prohibited
• Enzyme inducing anti-epileptic drugs
• Consumption of grapefruit, grapefruit juice, pomegranates, star fruits, Seville oranges or products within 7 days prior to first dose

Sponsors & Collaborators

• University of Chicago: lead
• Novartis: collaborator

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Papillomavirus Infections; Nasopharyngeal Neoplasms

Interventions

infigratinib

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Limitations and Caveats

Study stopped enrollment due to poor accrual. Outcomes measures could not be analyzed due to lack of enrollment.

Results Point of Contact

• Title: Technical Director
• Organization: University of Chicago Comprehensive Cancer Center

pccc_regulatory@bsd.uchicago.edu

773-702-0819

Study Officials

• Tanguy Seiwert

  University of Chicago Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2016
• First Posted: March 11, 2016
• Study Start: June 1, 2018
• Primary Completion: February 11, 2019
• Study Completion: February 11, 2019
• Last Updated: April 16, 2019
• Results First Posted: April 10, 2019

Record last verified: 2019-04

Locations

US (1)