Clinical trial NCT02160041: BGJ398 for Patients With Tumors With FGFR Genetic Alterations
Official title: Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors: Module 6 - BGJ398 for Patients With Tumors With FGFR Genetic Alterations
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Solid Tumor
Hematologic Malignancies
Keywords: Solid tumor malignancy
hematologic malignancy
mutation
translocations
amplifications,
fusions
signature
FGFR
ligand
BGJ398
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-06-10
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical Benefit Rate (CBR) Associated With BGJ398 Treatment
timeFrame: 16 weeks
Secondary outcomes:
measure: Overall Response (OR) or Partial Response (PR) or Greater
timeFrame: baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months
measure: Progression-Free Survival (PFS)
timeFrame: every 8 weeks until death, assessed up to 24 months
measure: Kaplan-Meier Estimates of PFS Rate, % (95% CI)
timeFrame: Months 1, 2, 3, 4, 5, 6, 12, 18, 24
measure: Overall Survival (OS)
timeFrame: every 8 weeks until death, assessed up to 36 months
measure: Kaplan-Meier Estimates of Survival Rate, % (95% CI)
timeFrame: months 3, 6, 9, 12, 24
measure: Number of Participants With 99 Day Minimum Duration of Response (DOR)
timeFrame: baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Oncology St. Vincent's Birmingham
state: Alabama
city: Oceanside
country: United States
facility: North County Oncology Medical Clinic Inc
state: California
city: San Francisco
country: United States
facility: San Francisco General Hospital San Francisco Gen Hosp (7)
state: California
city: Greenwood Village
country: United States
facility: Rocky Mountain Cancer Centers Rocky Mountain Cancer Ctr (50)
state: Colorado
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Fort Myers
country: United States
facility: Florida Cancer Specialists Florida Cancer Specialists 36
state: Florida
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer
state: Florida
city: Marietta
country: United States
facility: NorthWest Georgia Oncology Centers NW Georgia Oncology
state: Georgia
city: Rome
country: United States
facility: Harbin Clinic Medical Oncology Clin. Res.
state: Georgia
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Chicago
country: United States
facility: Lurie Children's Hospital of Chicago Developmental Therapeutics
state: Illinois
city: Anderson
country: United States
facility: Community Clinical Research Center
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Indiana Univ. - Purdue Univ.
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Cancer Research Consortium No. Indiana Cancer Res.
state: Indiana
city: Louisville
country: United States
facility: University of Louisville / James Graham Brown Cancer Center SC
state: Kentucky
city: Baltimore
country: United States
facility: St. Agnes Hospital St. Agnes Hospital (2)
state: Maryland
city: Fairhaven
country: United States
facility: Southcoast Centers for Cancer Care
state: Massachusetts
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of West Michigan Dept. of Oncology
state: Michigan
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, P.A. Minnesota Oncology Hem (27)
state: Minnesota
city: Kansas City
country: United States
facility: Research Medical Center Research Med Center (2)
state: Missouri
city: Billings
country: United States
facility: Billings Clinic Billings Clinic (8)
state: Montana
city: Bedford
country: United States
facility: Dartmouth Hitchcock Medical Center Dartmouth Hitchcock - Lebanon
state: New Hampshire
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Cancer Center
state: New Mexico
city: Cary
country: United States
facility: Waverly Hematology Oncology
state: North Carolina
city: Chapel Hill
country: United States
facility: University of N C at Chapel Hill Physician Office Building
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center Seeley G. Mudd Bldg.
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Hem & Onc Medical Center
state: North Carolina
city: Fargo
country: United States
facility: Sanford Hematology Oncology
state: North Dakota
city: Cincinnati
country: United States
facility: Oncology Hematology Care Inc Oncology Hematology Care 2
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland Seidman Cancer Center University Hospitals
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation Taussig Cancer Institute
state: Ohio
city: Bend
country: United States
facility: Bend Memorial Clinic Bend Mem. Clinic
state: Oregon
city: Portland
country: United States
facility: Northwest Cancer Specialists Northwest Cancer
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: Cancer Treatment Centers of America Eastern Regional Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute Hillman Cancer Center (2)
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital Rhode Island Hosp. (2)
state: Rhode Island
city: Sioux Falls
country: United States
facility: Sanford University of South Dakota Medical Center Sanford Health
state: South Dakota
city: Chattanooga
country: United States
facility: Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology Tennessee Oncology (3)
state: Tennessee
city: Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
city: Houston
country: United States
facility: Oncology Consultants Oncology Group
state: Texas
city: Houston
country: United States
facility: Houston Methodist Cancer Center
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3)
state: Texas
city: McAllen
country: United States
facility: Texas Oncology
state: Texas
city: San Antonio
country: United States
facility: Cancer Therapy & Research Center UT Health Science Center Oncology Dept.
state: Texas
city: Waco
country: United States
facility: Texas Oncology Cancer Care & Research Center Texas Oncology
state: Texas
city: Webster
country: United States
facility: Deke Slayton Cancer Center Deke Slayton Cancer Center (2)
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center Intermountain Healthcare
state: Utah
city: Ogden
country: United States
facility: Northern Utah Cancer Associates Northern Utah Assoc (3)
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah / Huntsman Cancer Institute SC-2
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists Utah Cancer Specialists (11)
state: Utah
city: Fairfax
country: United States
facility: Virginia Cancer Specialists Fairfax Northern Virginia
state: Virginia
city: Winchester
country: United States
facility: Shenandoah Oncology Shenandoah Oncology (5)
state: Virginia
city: Tacoma
country: United States
facility: Northwest Medical Specialties NW Medical Specialties
state: Washington
Study officials:
References: