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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02160041
Other study ID # CBGJ398XUS04
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date July 24, 2014
Est. completion date April 30, 2018

Study information

Verified date May 2019
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 84
Est. completion date April 30, 2018
Est. primary completion date April 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
United States New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Health Network Allentown Pennsylvania
United States Community Clinical Research Center Anderson Indiana
United States Illinois Cancer Specialists Arlington Heights Illinois
United States St. Agnes Hospital St. Agnes Hospital (2) Baltimore Maryland
United States Dartmouth Hitchcock Medical Center Dartmouth Hitchcock - Lebanon Bedford New Hampshire
United States Bend Memorial Clinic Bend Mem. Clinic Bend Oregon
United States Billings Clinic Billings Clinic (8) Billings Montana
United States Alabama Oncology St. Vincent's Birmingham Birmingham Alabama
United States Waverly Hematology Oncology Cary North Carolina
United States University of N C at Chapel Hill Physician Office Building Chapel Hill North Carolina
United States Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology Chattanooga Tennessee
United States Lurie Children's Hospital of Chicago Developmental Therapeutics Chicago Illinois
United States Oncology Hematology Care Inc Oncology Hematology Care 2 Cincinnati Ohio
United States Cleveland Clinic Foundation Taussig Cancer Institute Cleveland Ohio
United States University Hospitals of Cleveland Seidman Cancer Center University Hospitals Cleveland Ohio
United States Duke University Medical Center Seeley G. Mudd Bldg. Durham North Carolina
United States Virginia Cancer Specialists Fairfax Northern Virginia Fairfax Virginia
United States Southcoast Centers for Cancer Care Fairhaven Massachusetts
United States Sanford Hematology Oncology Fargo North Dakota
United States Florida Cancer Specialists Florida Cancer Specialists 36 Fort Myers Florida
United States The Center for Cancer and Blood Disorders Fort Worth Texas
United States Cancer and Hematology Centers of West Michigan Dept. of Oncology Grand Rapids Michigan
United States Rocky Mountain Cancer Centers Rocky Mountain Cancer Ctr (50) Greenwood Village Colorado
United States Houston Methodist Cancer Center Houston Texas
United States MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3) Houston Texas
United States Oncology Consultants Oncology Group Houston Texas
United States Indiana University Indiana Univ. - Purdue Univ. Indianapolis Indiana
United States Research Medical Center Research Med Center (2) Kansas City Missouri
United States University of Louisville / James Graham Brown Cancer Center SC Louisville Kentucky
United States NorthWest Georgia Oncology Centers NW Georgia Oncology Marietta Georgia
United States Texas Oncology McAllen Texas
United States University of Miami Sylvester Comprehensive Cancer Miami Florida
United States Minnesota Oncology Hematology, P.A. Minnesota Oncology Hem (27) Minneapolis Minnesota
United States Intermountain Medical Center Intermountain Healthcare Murray Utah
United States Tennessee Oncology Tennessee Oncology (3) Nashville Tennessee
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Norwalk Hospital Norwalk Connecticut
United States North County Oncology Medical Clinic Inc Oceanside California
United States Northern Utah Cancer Associates Northern Utah Assoc (3) Ogden Utah
United States Cancer Treatment Centers of America Eastern Regional Medical Center Philadelphia Pennsylvania
United States University of Pittsburgh Cancer Institute Hillman Cancer Center (2) Pittsburgh Pennsylvania
United States Northwest Cancer Specialists Northwest Cancer Portland Oregon
United States Rhode Island Hospital Rhode Island Hosp. (2) Providence Rhode Island
United States Harbin Clinic Medical Oncology Clin. Res. Rome Georgia
United States University of Utah / Huntsman Cancer Institute SC-2 Salt Lake City Utah
United States Utah Cancer Specialists Utah Cancer Specialists (11) Salt Lake City Utah
United States Cancer Therapy & Research Center UT Health Science Center Oncology Dept. San Antonio Texas
United States San Francisco General Hospital San Francisco Gen Hosp (7) San Francisco California
United States Sanford University of South Dakota Medical Center Sanford Health Sioux Falls South Dakota
United States Northern Indiana Cancer Research Consortium No. Indiana Cancer Res. South Bend Indiana
United States Northwest Medical Specialties NW Medical Specialties Tacoma Washington
United States Texas Oncology Cancer Care & Research Center Texas Oncology Waco Texas
United States Deke Slayton Cancer Center Deke Slayton Cancer Center (2) Webster Texas
United States Shenandoah Oncology Shenandoah Oncology (5) Winchester Virginia
United States Wake Forest Baptist Health Hem & Onc Medical Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Overall Response (OR) or Partial Response (PR) or Greater 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 + PR
baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months
Secondary Progression-Free Survival (PFS) 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 cause
every 8 weeks until death, assessed up to 24 months
Secondary Kaplan-Meier Estimates of PFS Rate, % (95% CI) Months 1, 2, 3, 4, 5, 6, 12, 18, 24
Secondary Overall Survival (OS) Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause every 8 weeks until death, assessed up to 36 months
Secondary Kaplan-Meier Estimates of Survival Rate, % (95% CI) 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. months 3, 6, 9, 12, 24
Secondary Number of Participants With 99 Day Minimum Duration of Response (DOR) 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 baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months
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