BGJ398 for Patients With Tumors With FGFR Genetic Alterations

Stopped early · Phase 2

Conditions studied: Solid Tumor, Hematologic Malignancies

In brief

The purpose of this signal seeking study was to determine whether treatment with BGJ398 demonstrates sufficient efficacy in select FGFR pathway-regulated solid tumors and/or hematologic malignancies to warrant further study.

Key facts

Study ID

NCT02160041

Run by

Novartis Pharmaceuticals

People needed

84

Starts

2014-07-24

Expected to finish

2018-04-30

Last updated by the study team

2019-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient has a confirmed diagnosis of a select solid tumor (except with a primary diagnosis of Urothelial cell carcinoma, Cholangiocarcinoma, Endometrial cancer, and Glioblastoma multiforme) or hematologic malignancies and is in need of treatment because of progression or relapse.
• Patient's tumor has been evaluated and pre-identified as having a tumor with a FGFR genetic alteration. The qualifying alteration must be assessed and reported by a CLIA-certified laboratory.
• Patient must have received at least one prior treatment for recurrent, metastatic and /or locally advanced disease and for whom no standard therapy options are anticipated to result in a durable remission.
• Patient must have progressive and measurable disease per RECIST 1.1. or other appropriate hematological response criteria.
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

You may not qualify if…

• Patient has received prior treatment with BGJ398
• Patients with Central Nervous System (CNS) metastasis or leptomeningeal carcinomatosis
• Patient has received chemotherapy or other anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug.
• Patients with acute or chronic pancreatitis
• Patients with impaired cardiac function or clinically significant cardiac diseases
• History and/or current evidence of extensive tissue calcification
• Use of medications that increase serum levels of phosphorus and/or calcium
• Current evidence of corneal or retinal disorder/keratopathy
• History and/or current evidence of renal or endocrine alterations of calcium/phosphate homeostasis
• Patients with another primary malignancy within 3 years prior to starting study treatment, with the exception of adequately treated basal cell carcinoma, squamous cell carcinoma or other non-melanomatous skin cancer, or in-situ carcinoma of the uterine cervix

Where it is running

• North County Oncology Medical Clinic Inc — Oceanside, California, United States
• San Francisco General Hospital San Francisco Gen Hosp (7) — San Francisco, California, United States
• Rocky Mountain Cancer Centers Rocky Mountain Cancer Ctr (50) — Greenwood Village, Colorado, United States
• Norwalk Hospital — Norwalk, Connecticut, United States
• Florida Cancer Specialists Florida Cancer Specialists 36 — Fort Myers, Florida, United States
• University of Miami Sylvester Comprehensive Cancer — Miami, Florida, United States
• NorthWest Georgia Oncology Centers NW Georgia Oncology — Marietta, Georgia, United States
• Harbin Clinic Medical Oncology Clin. Res. — Rome, Georgia, United States
• Illinois Cancer Specialists — Arlington Heights, Illinois, United States
• Lurie Children's Hospital of Chicago Developmental Therapeutics — Chicago, Illinois, United States
• Community Clinical Research Center — Anderson, Indiana, United States
• Indiana University Indiana Univ. - Purdue Univ. — Indianapolis, Indiana, United States
• Northern Indiana Cancer Research Consortium No. Indiana Cancer Res. — South Bend, Indiana, United States
• University of Louisville / James Graham Brown Cancer Center SC — Louisville, Kentucky, United States
• St. Agnes Hospital St. Agnes Hospital (2) — Baltimore, Maryland, United States
• Southcoast Centers for Cancer Care — Fairhaven, Massachusetts, United States
• Cancer and Hematology Centers of West Michigan Dept. of Oncology — Grand Rapids, Michigan, United States
• Minnesota Oncology Hematology, P.A. Minnesota Oncology Hem (27) — Minneapolis, Minnesota, United States
• Research Medical Center Research Med Center (2) — Kansas City, Missouri, United States
• Billings Clinic Billings Clinic (8) — Billings, Montana, United States
• Dartmouth Hitchcock Medical Center Dartmouth Hitchcock - Lebanon — Bedford, New Hampshire, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• New Mexico Cancer Center — Albuquerque, New Mexico, United States
• Waverly Hematology Oncology — Cary, North Carolina, United States
• Alabama Oncology St. Vincent's Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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