Georgia's Online Cancer Information Center

Find A Clinical Trial

BGJ398 for Patients With Tumors With FGFR Genetic Alterations

Status
Completed
Cancer Type
Hematopoietic Malignancies
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT02160041
Protocol IDs
CBGJ398XUS04 (primary)
Study Sponsor
Novartis Pharmaceuticals Corporation

Summary

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.

Eligibility

  1. Inclusion Criteria: 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 Exclusion Criteria: 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

Treatment Sites in Georgia

Northwest Georgia Oncology Centers - Austell


1700 Hospital South Drive
Suite 300
Austell, GA 30106
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Sujatha Hariharan MD
Carlos A. Osmon MD

Northwest Georgia Oncology Centers - Bremen


200 Allen Memorial Drive
Suite 302-B
Bremen, GA 30110
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Bradley J.G. Larson MD

Northwest Georgia Oncology Centers - Carrollton


157 Clinic Avenue
Suite 101
Carrollton, GA 30117
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Bradley J.G. Larson MD
Randall E. Pierce MD

Northwest Georgia Oncology Centers - Cartersville


100 Market Place Boulevard
Suite 200
Cartersville, GA 30121
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Satyen R. Mehta MD
Madhurima Uppalapati MD

Northwest Georgia Oncology Centers - Douglasville


6002 Professional Parkway
Suite 220
Douglasville, GA 30134
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Navin P. Wadehra MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Jasper


1020 J.L. White Drive
Suite 160
Jasper, GA 30143
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Curtis R. Miles MD

Northwest Georgia Oncology Centers - Paulding


144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Kathleen A. Long MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Villa Rica


705 Dallas Highway
Suite 204
Villa Rica, GA 30180
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Randall E. Pierce MD
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.