BGJ398 for Patients With Tumors With FGFR Genetic Alterations
- Conditions
- Solid TumorHematologic Malignancies
- Interventions
- Drug: BGJ398
- Registration Number
- NCT02160041
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 84
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BGJ398 BGJ398 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.
- Primary Outcome Measures
Name Time Method Clinical Benefit Rate (CBR) Associated With BGJ398 Treatment 16 weeks 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
- Secondary Outcome Measures
Name Time Method Kaplan-Meier Estimates of Survival Rate, % (95% CI) months 3, 6, 9, 12, 24 Overall survival (OS) is the time from the date of start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last contact.
Progression-Free Survival (PFS) every 8 weeks until death, assessed up to 24 months Kaplan-Meier estimates of PFS timing, months
Progression free survival (PFS) is defined as the time from the date of first dose to the date of first documented disease progression or relapse or death due to any causeOverall Survival (OS) every 8 weeks until death, assessed up to 36 months Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause
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 The key secondary endpoint, OR, was determined by Investigator assessment for each tumor assessment and defined as responses of CR and PR per RECIST version 1.1.
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 + PRKaplan-Meier Estimates of PFS Rate, % (95% CI) Months 1, 2, 3, 4, 5, 6, 12, 18, 24 Number of Participants With 99 Day Minimum Duration of Response (DOR) baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months The duration of response (PR or greater) applies only to patients whose best response was PR or greater. It is defined as the Ttime from the first documented response to the date first documented disease progression or relapse or death due to any cause
Trial Locations
- Locations (56)
Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology
🇺🇸Chattanooga, Tennessee, United States
Virginia Cancer Specialists Fairfax Northern Virginia
🇺🇸Fairfax, Virginia, United States
Duke University Medical Center Seeley G. Mudd Bldg.
🇺🇸Durham, North Carolina, United States
University Hospitals of Cleveland Seidman Cancer Center University Hospitals
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Foundation Taussig Cancer Institute
🇺🇸Cleveland, Ohio, United States
University of Pittsburgh Cancer Institute Hillman Cancer Center (2)
🇺🇸Pittsburgh, Pennsylvania, United States
Lurie Children's Hospital of Chicago Developmental Therapeutics
🇺🇸Chicago, Illinois, United States
MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3)
🇺🇸Houston, Texas, United States
Cancer Therapy & Research Center UT Health Science Center Oncology Dept.
🇺🇸San Antonio, Texas, United States
Utah Cancer Specialists Utah Cancer Specialists (11)
🇺🇸Salt Lake City, Utah, United States
Billings Clinic Billings Clinic (8)
🇺🇸Billings, Montana, United States
Northwest Cancer Specialists Northwest Cancer
🇺🇸Portland, Oregon, United States
Intermountain Medical Center Intermountain Healthcare
🇺🇸Murray, Utah, United States
Bend Memorial Clinic Bend Mem. Clinic
🇺🇸Bend, Oregon, United States
Cancer and Hematology Centers of West Michigan Dept. of Oncology
🇺🇸Grand Rapids, Michigan, United States
North County Oncology Medical Clinic Inc
🇺🇸Oceanside, California, United States
San Francisco General Hospital San Francisco Gen Hosp (7)
🇺🇸San Francisco, California, United States
Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
Florida Cancer Specialists Florida Cancer Specialists 36
🇺🇸Fort Myers, Florida, United States
NorthWest Georgia Oncology Centers NW Georgia Oncology
🇺🇸Marietta, Georgia, United States
Oncology Hematology Care Inc Oncology Hematology Care 2
🇺🇸Cincinnati, Ohio, United States
Southcoast Centers for Cancer Care
🇺🇸Fairhaven, Massachusetts, United States
Harbin Clinic Medical Oncology Clin. Res.
🇺🇸Rome, Georgia, United States
Community Clinical Research Center
🇺🇸Anderson, Indiana, United States
Illinois Cancer Specialists
🇺🇸Arlington Heights, Illinois, United States
Indiana University Indiana Univ. - Purdue Univ.
🇺🇸Indianapolis, Indiana, United States
Minnesota Oncology Hematology, P.A. Minnesota Oncology Hem (27)
🇺🇸Minneapolis, Minnesota, United States
Northern Indiana Cancer Research Consortium No. Indiana Cancer Res.
🇺🇸South Bend, Indiana, United States
St. Agnes Hospital St. Agnes Hospital (2)
🇺🇸Baltimore, Maryland, United States
Research Medical Center Research Med Center (2)
🇺🇸Kansas City, Missouri, 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
University of N C at Chapel Hill Physician Office Building
🇺🇸Chapel Hill, North Carolina, United States
Sanford Hematology Oncology
🇺🇸Fargo, North Dakota, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
Cancer Treatment Centers of America Eastern Regional Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
Oncology Consultants Oncology Group
🇺🇸Houston, Texas, United States
Tennessee Oncology Tennessee Oncology (3)
🇺🇸Nashville, Tennessee, United States
Houston Methodist Cancer Center
🇺🇸Houston, Texas, United States
Texas Oncology
🇺🇸McAllen, Texas, United States
Northern Utah Cancer Associates Northern Utah Assoc (3)
🇺🇸Ogden, Utah, United States
University of Utah / Huntsman Cancer Institute SC-2
🇺🇸Salt Lake City, Utah, United States
Alabama Oncology St. Vincent's Birmingham
🇺🇸Birmingham, Alabama, United States
University of Louisville / James Graham Brown Cancer Center SC
🇺🇸Louisville, Kentucky, United States
Wake Forest Baptist Health Hem & Onc Medical Center
🇺🇸Winston-Salem, North Carolina, United States
The Center for Cancer and Blood Disorders
🇺🇸Fort Worth, Texas, United States
University of Miami Sylvester Comprehensive Cancer
🇺🇸Miami, Florida, United States
Waverly Hematology Oncology
🇺🇸Cary, North Carolina, United States
Sanford University of South Dakota Medical Center Sanford Health
🇺🇸Sioux Falls, South Dakota, United States
Rhode Island Hospital Rhode Island Hosp. (2)
🇺🇸Providence, Rhode Island, United States
Deke Slayton Cancer Center Deke Slayton Cancer Center (2)
🇺🇸Webster, Texas, United States
Texas Oncology Cancer Care & Research Center Texas Oncology
🇺🇸Waco, Texas, United States
Shenandoah Oncology Shenandoah Oncology (5)
🇺🇸Winchester, Virginia, United States
Northwest Medical Specialties NW Medical Specialties
🇺🇸Tacoma, Washington, United States
New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States
Rocky Mountain Cancer Centers Rocky Mountain Cancer Ctr (50)
🇺🇸Greenwood Village, Colorado, United States
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