BGJ398 for Patients With Tumors With FGFR Genetic Alterations

NCT02160041 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: CBGJ398XUS04
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 56

Brief 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.

Conditions

Solid Tumor; Hematologic Malignancies

Keywords

Solid tumor malignancy; hematologic malignancy; mutation; translocations; amplifications,; fusions; signature; FGFR; ligand; BGJ398

Outcome Measures

Primary Outcomes (1)

• Clinical Benefit Rate (CBR) Associated With BGJ398 Treatment

  Tumor Response: Overall response rate (ORR) and clinical benefit rate (CBR) for solid tumor (non-lymphoma) which excludes 3 TIO and 1 Lymphoma patients (hence 80 patients and not 84) Clinical benefit rate for patients with solid tumors were assessed using RECIST 1.1 and include responses of CR or PR or SD. For hematologic tumors other appropriate hematological response criteria may apply Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  16 weeks

Secondary Outcomes (6)

• Overall Response (OR) or Partial Response (PR) or Greater

  baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months

• Progression-Free Survival (PFS)

  every 8 weeks until death, assessed up to 24 months

• Kaplan-Meier Estimates of PFS Rate, % (95% CI)

  Months 1, 2, 3, 4, 5, 6, 12, 18, 24

• Overall Survival (OS)

  every 8 weeks until death, assessed up to 36 months

• Kaplan-Meier Estimates of Survival Rate, % (95% CI)

  months 3, 6, 9, 12, 24

Study Arms (1)

BGJ398

EXPERIMENTAL

BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.

Drug: BGJ398

Interventions

BGJ398 DRUG

BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.

BGJ398

Eligibility Criteria

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

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (56)

Alabama Oncology St. Vincent's Birmingham

Birmingham, Alabama, 35211, United States

Location

North County Oncology Medical Clinic Inc

Oceanside, California, 92056, United States

Location

San Francisco General Hospital San Francisco Gen Hosp (7)

San Francisco, California, 94110, United States

Location

Rocky Mountain Cancer Centers Rocky Mountain Cancer Ctr (50)

Greenwood Village, Colorado, 80304, United States

Location

Norwalk Hospital

Norwalk, Connecticut, 06856, United States

Location

Florida Cancer Specialists Florida Cancer Specialists 36

Fort Myers, Florida, 33901, United States

Location

University of Miami Sylvester Comprehensive Cancer

Miami, Florida, 33136, United States

Location

NorthWest Georgia Oncology Centers NW Georgia Oncology

Marietta, Georgia, 30060, United States

Location

Harbin Clinic Medical Oncology Clin. Res.

Rome, Georgia, 30165, United States

Location

Illinois Cancer Specialists

Arlington Heights, Illinois, 60005, United States

Location

Lurie Children's Hospital of Chicago Developmental Therapeutics

Chicago, Illinois, 60611, United States

Location

Community Clinical Research Center

Anderson, Indiana, 46011, United States

Location

Indiana University Indiana Univ. - Purdue Univ.

Indianapolis, Indiana, 46202, United States

Location

Northern Indiana Cancer Research Consortium No. Indiana Cancer Res.

South Bend, Indiana, 46617, United States

Location

University of Louisville / James Graham Brown Cancer Center SC

Louisville, Kentucky, 40202, United States

Location

St. Agnes Hospital St. Agnes Hospital (2)

Baltimore, Maryland, 21229, United States

Location

Southcoast Centers for Cancer Care

Fairhaven, Massachusetts, 02719, United States

Location

Cancer and Hematology Centers of West Michigan Dept. of Oncology

Grand Rapids, Michigan, 49546, United States

Location

Minnesota Oncology Hematology, P.A. Minnesota Oncology Hem (27)

Minneapolis, Minnesota, 55404, United States

Location

Research Medical Center Research Med Center (2)

Kansas City, Missouri, 64132, United States

Location

Billings Clinic Billings Clinic (8)

Billings, Montana, 59101, United States

Location

Dartmouth Hitchcock Medical Center Dartmouth Hitchcock - Lebanon

Bedford, New Hampshire, 03110, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

New Mexico Cancer Center

Albuquerque, New Mexico, 87109, United States

Location

Waverly Hematology Oncology

Cary, North Carolina, 27518, United States

Location

University of N C at Chapel Hill Physician Office Building

Chapel Hill, North Carolina, 27599-7600, United States

Location

Duke University Medical Center Seeley G. Mudd Bldg.

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Health Hem & Onc Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Sanford Hematology Oncology

Fargo, North Dakota, 58122, United States

Location

Oncology Hematology Care Inc Oncology Hematology Care 2

Cincinnati, Ohio, 45242, United States

Location

University Hospitals of Cleveland Seidman Cancer Center University Hospitals

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic Foundation Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

Location

Bend Memorial Clinic Bend Mem. Clinic

Bend, Oregon, 97701, United States

Location

Northwest Cancer Specialists Northwest Cancer

Portland, Oregon, 97210, United States

Location

Lehigh Valley Health Network

Allentown, Pennsylvania, 18103, United States

Location

Cancer Treatment Centers of America Eastern Regional Medical Center

Philadelphia, Pennsylvania, 19124, United States

Location

University of Pittsburgh Cancer Institute Hillman Cancer Center (2)

Pittsburgh, Pennsylvania, 15232, United States

Location

Rhode Island Hospital Rhode Island Hosp. (2)

Providence, Rhode Island, 02903, United States

Location

Sanford University of South Dakota Medical Center Sanford Health

Sioux Falls, South Dakota, 57104, United States

Location

Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology Tennessee Oncology (3)

Nashville, Tennessee, 37203, United States

Location

The Center for Cancer and Blood Disorders

Fort Worth, Texas, 76104, United States

Location

Oncology Consultants Oncology Group

Houston, Texas, 77024, United States

Location

Houston Methodist Cancer Center

Houston, Texas, 77030, United States

Location

MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3)

Houston, Texas, 77030, United States

Location

Texas Oncology

McAllen, Texas, 78503, United States

Location

Cancer Therapy & Research Center UT Health Science Center Oncology Dept.

San Antonio, Texas, 78229, United States

Location

Texas Oncology Cancer Care & Research Center Texas Oncology

Waco, Texas, 76712, United States

Location

Deke Slayton Cancer Center Deke Slayton Cancer Center (2)

Webster, Texas, 77598, United States

Location

Intermountain Medical Center Intermountain Healthcare

Murray, Utah, 84157, United States

Location

Northern Utah Cancer Associates Northern Utah Assoc (3)

Ogden, Utah, 84403, United States

Location

University of Utah / Huntsman Cancer Institute SC-2

Salt Lake City, Utah, 84103, United States

Location

Utah Cancer Specialists Utah Cancer Specialists (11)

Salt Lake City, Utah, 84106, United States

Location

Virginia Cancer Specialists Fairfax Northern Virginia

Fairfax, Virginia, 22031, United States

Location

Shenandoah Oncology Shenandoah Oncology (5)

Winchester, Virginia, 22601, United States

Location

Northwest Medical Specialties NW Medical Specialties

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

infigratinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+1 (800) 778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 10, 2014
• Study Start: July 24, 2014
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: June 18, 2019
• Results First Posted: June 18, 2019

Record last verified: 2019-05

Locations

US (56)