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BGJ398 for Patients With Tumors With FGFR Genetic Alterations (CBGJ398XUS04)

Primary Purpose

Solid Tumor, Hematologic Malignancies

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BGJ398
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor focused on measuring Solid tumor malignancy, hematologic malignancy, mutation, translocations, amplifications,, fusions, signature, FGFR, ligand, BGJ398

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alabama Oncology St. Vincent's Birmingham
  • North County Oncology Medical Clinic Inc
  • San Francisco General Hospital San Francisco Gen Hosp (7)
  • Rocky Mountain Cancer Centers Rocky Mountain Cancer Ctr (50)
  • Norwalk Hospital
  • Florida Cancer Specialists Florida Cancer Specialists 36
  • University of Miami Sylvester Comprehensive Cancer
  • NorthWest Georgia Oncology Centers NW Georgia Oncology
  • Harbin Clinic Medical Oncology Clin. Res.
  • Illinois Cancer Specialists
  • Lurie Children's Hospital of Chicago Developmental Therapeutics
  • Community Clinical Research Center
  • Indiana University Indiana Univ. - Purdue Univ.
  • Northern Indiana Cancer Research Consortium No. Indiana Cancer Res.
  • University of Louisville / James Graham Brown Cancer Center SC
  • St. Agnes Hospital St. Agnes Hospital (2)
  • Southcoast Centers for Cancer Care
  • Cancer and Hematology Centers of West Michigan Dept. of Oncology
  • Minnesota Oncology Hematology, P.A. Minnesota Oncology Hem (27)
  • Research Medical Center Research Med Center (2)
  • Billings Clinic Billings Clinic (8)
  • Dartmouth Hitchcock Medical Center Dartmouth Hitchcock - Lebanon
  • Rutgers Cancer Institute of New Jersey
  • New Mexico Cancer Center
  • Waverly Hematology Oncology
  • University of N C at Chapel Hill Physician Office Building
  • Duke University Medical Center Seeley G. Mudd Bldg.
  • Wake Forest Baptist Health Hem & Onc Medical Center
  • Sanford Hematology Oncology
  • Oncology Hematology Care Inc Oncology Hematology Care 2
  • University Hospitals of Cleveland Seidman Cancer Center University Hospitals
  • Cleveland Clinic Foundation Taussig Cancer Institute
  • Bend Memorial Clinic Bend Mem. Clinic
  • Northwest Cancer Specialists Northwest Cancer
  • Lehigh Valley Health Network
  • Cancer Treatment Centers of America Eastern Regional Medical Center
  • University of Pittsburgh Cancer Institute Hillman Cancer Center (2)
  • Rhode Island Hospital Rhode Island Hosp. (2)
  • Sanford University of South Dakota Medical Center Sanford Health
  • Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology
  • Tennessee Oncology Tennessee Oncology (3)
  • The Center for Cancer and Blood Disorders
  • Oncology Consultants Oncology Group
  • Houston Methodist Cancer Center
  • MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3)
  • Texas Oncology
  • Cancer Therapy & Research Center UT Health Science Center Oncology Dept.
  • Texas Oncology Cancer Care & Research Center Texas Oncology
  • Deke Slayton Cancer Center Deke Slayton Cancer Center (2)
  • Intermountain Medical Center Intermountain Healthcare
  • Northern Utah Cancer Associates Northern Utah Assoc (3)
  • University of Utah / Huntsman Cancer Institute SC-2
  • Utah Cancer Specialists Utah Cancer Specialists (11)
  • Virginia Cancer Specialists Fairfax Northern Virginia
  • Shenandoah Oncology Shenandoah Oncology (5)
  • Northwest Medical Specialties NW Medical Specialties

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BGJ398

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 6, 2014
Last Updated
May 28, 2019
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02160041
Brief Title
BGJ398 for Patients With Tumors With FGFR Genetic Alterations
Acronym
CBGJ398XUS04
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Study Start Date
July 24, 2014 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Hematologic Malignancies
Keywords
Solid tumor malignancy, hematologic malignancy, mutation, translocations, amplifications,, fusions, signature, FGFR, ligand, BGJ398

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BGJ398
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
BGJ398
Intervention Description
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 Measure Information:
Title
Clinical Benefit Rate (CBR) Associated With BGJ398 Treatment
Description
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
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Overall Response (OR) or Partial Response (PR) or Greater
Description
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
Time Frame
baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months
Title
Progression-Free Survival (PFS)
Description
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
Time Frame
every 8 weeks until death, assessed up to 24 months
Title
Kaplan-Meier Estimates of PFS Rate, % (95% CI)
Time Frame
Months 1, 2, 3, 4, 5, 6, 12, 18, 24
Title
Overall Survival (OS)
Description
Overall survival (OS) is defined as the time from the date of first dose to the date of death due to any cause
Time Frame
every 8 weeks until death, assessed up to 36 months
Title
Kaplan-Meier Estimates of Survival Rate, % (95% CI)
Description
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.
Time Frame
months 3, 6, 9, 12, 24
Title
Number of Participants With 99 Day Minimum Duration of Response (DOR)
Description
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
Time Frame
baseline and every 8 weeks until disease progression or end of treatment, assessed up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Alabama Oncology St. Vincent's Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
North County Oncology Medical Clinic Inc
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
San Francisco General Hospital San Francisco Gen Hosp (7)
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Rocky Mountain Cancer Centers Rocky Mountain Cancer Ctr (50)
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
Florida Cancer Specialists Florida Cancer Specialists 36
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
University of Miami Sylvester Comprehensive Cancer
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
NorthWest Georgia Oncology Centers NW Georgia Oncology
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Harbin Clinic Medical Oncology Clin. Res.
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
Illinois Cancer Specialists
City
Arlington Heights
State/Province
Illinois
ZIP/Postal Code
60005
Country
United States
Facility Name
Lurie Children's Hospital of Chicago Developmental Therapeutics
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Community Clinical Research Center
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
Indiana University Indiana Univ. - Purdue Univ.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Northern Indiana Cancer Research Consortium No. Indiana Cancer Res.
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
University of Louisville / James Graham Brown Cancer Center SC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
St. Agnes Hospital St. Agnes Hospital (2)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Southcoast Centers for Cancer Care
City
Fairhaven
State/Province
Massachusetts
ZIP/Postal Code
02719
Country
United States
Facility Name
Cancer and Hematology Centers of West Michigan Dept. of Oncology
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Minnesota Oncology Hematology, P.A. Minnesota Oncology Hem (27)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Research Medical Center Research Med Center (2)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
Billings Clinic Billings Clinic (8)
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center Dartmouth Hitchcock - Lebanon
City
Bedford
State/Province
New Hampshire
ZIP/Postal Code
03110
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Waverly Hematology Oncology
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
University of N C at Chapel Hill Physician Office Building
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7600
Country
United States
Facility Name
Duke University Medical Center Seeley G. Mudd Bldg.
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest Baptist Health Hem & Onc Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Sanford Hematology Oncology
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Oncology Hematology Care Inc Oncology Hematology Care 2
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
University Hospitals of Cleveland Seidman Cancer Center University Hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Foundation Taussig Cancer Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Bend Memorial Clinic Bend Mem. Clinic
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Northwest Cancer Specialists Northwest Cancer
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Cancer Treatment Centers of America Eastern Regional Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19124
Country
United States
Facility Name
University of Pittsburgh Cancer Institute Hillman Cancer Center (2)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Rhode Island Hospital Rhode Island Hosp. (2)
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Sanford University of South Dakota Medical Center Sanford Health
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology Tennessee Oncology (3)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The Center for Cancer and Blood Disorders
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Oncology Consultants Oncology Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Houston Methodist Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MD Anderson Cancer Center/University of Texas MD Anderson Cancer Center (3)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Cancer Therapy & Research Center UT Health Science Center Oncology Dept.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Texas Oncology Cancer Care & Research Center Texas Oncology
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Deke Slayton Cancer Center Deke Slayton Cancer Center (2)
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Intermountain Medical Center Intermountain Healthcare
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
Northern Utah Cancer Associates Northern Utah Assoc (3)
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
University of Utah / Huntsman Cancer Institute SC-2
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
Utah Cancer Specialists Utah Cancer Specialists (11)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Virginia Cancer Specialists Fairfax Northern Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Shenandoah Oncology Shenandoah Oncology (5)
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Northwest Medical Specialties NW Medical Specialties
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Learn more about this trial

BGJ398 for Patients With Tumors With FGFR Genetic Alterations

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