BGJ398 in Non-Muscle-Invasive Urothelial Carcinoma of the Bladder

NCT02657486 | Completed

• 1 other identifier: 15-090
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to study the activity and effects of BGJ398 on bladder cancer tumors that are confined to the lining of the bladder.

Conditions

Bladder Cancer; Non-Muscle-Invasive Urothelial Carcinoma

Keywords

BGJ398; 15-090

Outcome Measures

Primary Outcomes (1)

• tumor response

  with cystoscopy and cytology. A complete response will be defined as complete disappearance of the marker lesion at the week 7 evaluation, as determined by a negative cystoscopy and cytology.

  week 7

Study Arms (1)

BGJ398

EXPERIMENTAL

BGJ398 will be administered at a dose of 125 mg orally once daily on a three weeks on, one week off schedule.

Drug: BGJ398

Interventions

BGJ398 DRUG

BGJ398

Eligibility Criteria

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

You may qualify if:

• Recurrent high-risk non-muscle-invasive bladder cancer after prior intravesical BCG therapy meeting all of the following criteria:
• Histologically documented diagnosis of urothelial carcinoma confirmed by the Department of Pathology at MSKCC.
• Documentation of activating FGFR3 mutation or gene fusion on an assay performed in a CLIA-certified laboratory.
• History of high-grade, non-muscle-invasive bladder cancer (NMIBC).
• Clinical evidence of high-grade, stage pTa NMIBC.
• Prior intravesical therapy with at least one induction course of BCG
• Multiple papillary lesions with at least one amenable to marker tumor study (≤1 cm, non-invasive; or could be partially resected to leave a non-invasive lesion ≤1 cm) OR solitary papillary lesion amenable to marker tumor study (≤1 cm, non-invasive)
• Patient must be willing to consent to MSKCC protocol 12-245 ("Tumor Genomic Profiling in Patients Evaluated for Targeted Cancer Therapy"
• Age 18 years or older.
• Patient must be willing and able to comply with scheduled visits, treatment plan, and laboratory tests.
• Patient must be able to swallow and retain oral medication.
• Karnofsky performance status of ≥80.
• Recovery from adverse events of previous systemic anti-cancer therapies to baseline or grade 1, except for:
• Alopecia
• Stable neuropathy of ≤ grade 2 due to prior cancer therapy

You may not qualify if:

• Clinical suspicion of active CIS.
• Evidence of \>1 area of CIS not associated with papillary tumor at this time.
• Evidence of \>7 tumors present in the bladder.
• History or evidence of advanced urothelial carcinoma, including enlarged lymph nodes and/or distant metastases.
• Evidence of upper tract urothelial carcinoma.
• History of another primary malignancy within the last 3 years except:
• Adequately treated in situ carcinoma of the cervix
• Non-melanoma carcinoma of the skin
• Any other curatively treated malignancy that has not been treated in the prior 3 months and is not expected to require treatment for recurrence during the course of the study.
• Patients who received prior treatment with a selective FGFR inhibitor.
• 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 tissue calcification including, but not limited to, the soft tissue, kidneys, intestine, myocardium, and lung with the exception of calcified lymph nodes and asymptomatic vascular calcification.
• Current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis, etc.
• Use of medications that increase serum levels of phosphorus and/or calcium (e.g., calcium, phosphate, vitamin D, parathyroid hormone;) .
• Current evidence of corneal or retinal disorder/keratopathy including, but not limited to, bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and/or keratoconjunctivitis, confirmed by ophthalmologic examination

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

infigratinib

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jonathan Rosenberg, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2016
• First Posted: January 15, 2016
• Study Start: January 6, 2016
• Primary Completion: February 4, 2026
• Study Completion: February 4, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (1)