Back to resultsA Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma
Primary Purpose
Advanced Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carfilzomib, proteasome inhibitor; intravenous
Filanesib, KSP(Eg5) inhibitor; intravenous
Dexamethasone, steroid; oral or intravenous
Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Multiple Myeloma
Eligibility Criteria
Key Inclusion Criteria:
- Confirmed multiple myeloma with measurable disease.
- Disease refractory to last myeloma regimen.
- Patients must have received at least 2 prior treatment regimens, including bortezomib and an IMiD (e.g., lenalidomide, thalidomide, pomalidomide). Induction therapy and stem cell transplant ± maintenance are to be considered as a single regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to first dose of study treatment.
- Adequate hematology, liver and renal function laboratory values within 14 days prior to first dose of study treatment.
- Additional criteria exist.
Key Exclusion Criteria:
- Prior treatment with carfilzomib, filanesib, or any other KSP inhibitor.
- Past or current plasma cell leukemia.
- Primary amyloidosis (amyloidosis associated with multiple myeloma is allowed).
- POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes).
- Ongoing Grade 3 or Grade 4 peripheral neuropathy, or Grade 2 peripheral neuropathy with pain despite appropriate interventions, within 28 days prior to first dose of study treatment.
- Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study treatment.
- Concomitant malignancies or previous malignancies (other than multiple myeloma) with less than a 2-year disease-free interval at the time of first dose of study treatment. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer are eligible irrespective of the time of diagnosis.
- Known pulmonary hypertension of any severity.
- Concurrent cardiac disease that, in the judgment of the Investigator, would make the patient inappropriate for study participation.
- Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C.
- Acute active infection requiring treatment.
- Additional criteria exist.
Sites / Locations
- Genesis Cancer Center
- UCLA
- St. Joseph Heritage Healthcare
- Florida Cancer Specialists
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University
- Crescent City Research Consortium
- Massachusetts General Hospital
- Karmanos Cancer Institute
- Forrest General Cancer Center
- Nebraska Cancer Specialists
- Memorial Sloan Kettering
- Levine Cancer Institute
- Oncology Hematology Care - Blue Ash
- Cleveland Clinic
- Ohio State University
- Knight Cancer Institute at Oregon Health & Science University
- Prairie Lakes Health Care System
- Sarah Cannon Research Institute
- Simmons Cancer Center - UT Southwestern Medical Center
- Virginia Cancer Specialists
- WVU - Mary Babb Randolph Cancer Center
- Medical College of Wisconsin Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Carfilzomib + Filanesib
Carfilzomib
Arm Description
Single agent + Carfilzomib arm. Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information. Filgrastim to be administered per the approved product prescribing information and institutional guidelines.
Single agent arm. Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information.
Outcomes
Primary Outcome Measures
Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of progression-free survival.
Secondary Outcome Measures
Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of objective response rate.
Assess the safety of both carfilzomib + study drug and single-agent carfilzomib in terms of adverse events, clinical laboratory tests and electrocardiograms.
Characterize the pharmacokinetics (PK) of study drug, carfilzomib and a carfilzomib metabolite in patients treated with carfilzomib + study drug in terms of plasma concentration-time profiles and model-based PK parameters.
Following crossover from single-agent carfilzomib, assess the efficacy of carfilzomib + study drug in terms of objective response rate.
Following crossover from single-agent carfilzomib, assess the safety of carfilzomib + study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01989325
Brief Title
A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase 2 study during which patients with advanced multiple myeloma will receive either carfilzomib alone (single-agent) or carfilzomib in combination with investigational study drug filanesib (ARRY-520). Patients will be followed to determine the effectiveness of both single-agent carfilzomib and carfilzomib + filanesib in treating myeloma. Patients will be allowed to crossover from single-agent carfilzomib to carfilzomib + filanesib if disease progression occurs. Approximately 75 patients from the US will be enrolled in this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carfilzomib + Filanesib
Arm Type
Experimental
Arm Description
Single agent + Carfilzomib arm.
Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information.
Filgrastim to be administered per the approved product prescribing information and institutional guidelines.
Arm Title
Carfilzomib
Arm Type
Experimental
Arm Description
Single agent arm.
Patients will be hydrated prior to and following carfilzomib administration and will be premedicated with dexamethasone, per the carfilzomib prescribing information.
Intervention Type
Drug
Intervention Name(s)
Carfilzomib, proteasome inhibitor; intravenous
Intervention Description
multiple dose, single schedule
Intervention Type
Drug
Intervention Name(s)
Filanesib, KSP(Eg5) inhibitor; intravenous
Intervention Description
multiple dose, single schedule
Intervention Type
Drug
Intervention Name(s)
Dexamethasone, steroid; oral or intravenous
Intervention Description
as indicated, per the carfilzomib prescribing information
Intervention Type
Drug
Intervention Name(s)
Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
Intervention Description
standard of care
Primary Outcome Measure Information:
Title
Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of progression-free survival.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of objective response rate.
Time Frame
18 months
Title
Assess the safety of both carfilzomib + study drug and single-agent carfilzomib in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time Frame
18 months
Title
Characterize the pharmacokinetics (PK) of study drug, carfilzomib and a carfilzomib metabolite in patients treated with carfilzomib + study drug in terms of plasma concentration-time profiles and model-based PK parameters.
Time Frame
6 months
Title
Following crossover from single-agent carfilzomib, assess the efficacy of carfilzomib + study drug in terms of objective response rate.
Time Frame
18 months
Title
Following crossover from single-agent carfilzomib, assess the safety of carfilzomib + study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time Frame
18 months
Other Pre-specified Outcome Measures:
Title
Evaluate patient serum levels of alpha 1-acid glycoprotein (AAG) at Baseline and during the treatment period.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Confirmed multiple myeloma with measurable disease.
Disease refractory to last myeloma regimen.
Patients must have received at least 2 prior treatment regimens, including bortezomib and an IMiD (e.g., lenalidomide, thalidomide, pomalidomide). Induction therapy and stem cell transplant ± maintenance are to be considered as a single regimen.
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to first dose of study treatment.
Adequate hematology, liver and renal function laboratory values within 14 days prior to first dose of study treatment.
Additional criteria exist.
Key Exclusion Criteria:
Prior treatment with carfilzomib, filanesib, or any other KSP inhibitor.
Past or current plasma cell leukemia.
Primary amyloidosis (amyloidosis associated with multiple myeloma is allowed).
POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes).
Ongoing Grade 3 or Grade 4 peripheral neuropathy, or Grade 2 peripheral neuropathy with pain despite appropriate interventions, within 28 days prior to first dose of study treatment.
Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study treatment.
Concomitant malignancies or previous malignancies (other than multiple myeloma) with less than a 2-year disease-free interval at the time of first dose of study treatment. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or Stage 1 prostate cancer are eligible irrespective of the time of diagnosis.
Known pulmonary hypertension of any severity.
Concurrent cardiac disease that, in the judgment of the Investigator, would make the patient inappropriate for study participation.
Known positive serology for the human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C.
Acute active infection requiring treatment.
Additional criteria exist.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Genesis Cancer Center
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
St. Joseph Heritage Healthcare
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33905
Country
United States
Facility Name
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Crescent City Research Consortium
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Forrest General Cancer Center
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Memorial Sloan Kettering
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Oncology Hematology Care - Blue Ash
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Knight Cancer Institute at Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Prairie Lakes Health Care System
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Simmons Cancer Center - UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
WVU - Mary Babb Randolph Cancer Center
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Learn more about this trial
A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma
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