Clinical trial NCT01989325: A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Multiple Myeloma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-11-21
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of progression-free survival.
timeFrame: 18 months
Secondary outcomes:
measure: Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of objective response rate.
timeFrame: 18 months
measure: Assess the safety of both carfilzomib + study drug and single-agent carfilzomib in terms of adverse events, clinical laboratory tests and electrocardiograms.
timeFrame: 18 months
measure: 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.
timeFrame: 6 months
measure: Following crossover from single-agent carfilzomib, assess the efficacy of carfilzomib + study drug in terms of objective response rate.
timeFrame: 18 months
measure: Following crossover from single-agent carfilzomib, assess the safety of carfilzomib + study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
timeFrame: 18 months
Other outcomes:
measure: Evaluate patient serum levels of alpha 1-acid glycoprotein (AAG) at Baseline and during the treatment period.
timeFrame: 18 months
Locations:
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Santa Rosa
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University
state: Illinois
city: Marrero
country: United States
facility: Crescent City Research Consortium
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Hattiesburg
country: United States
facility: Forrest General Cancer Center
state: Mississippi
city: Omaha
country: United States
facility: Nebraska Cancer Specialists
state: Nebraska
city: New York
country: United States
facility: Memorial Sloan Kettering
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care - Blue Ash
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Portland
country: United States
facility: Knight Cancer Institute at Oregon Health & Science University
state: Oregon
city: Watertown
country: United States
facility: Prairie Lakes Health Care System
state: South Dakota
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Simmons Cancer Center - UT Southwestern Medical Center
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Morgantown
country: United States
facility: WVU - Mary Babb Randolph Cancer Center
state: West Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Cancer Center
state: Wisconsin
Study officials:
affiliation: Pfizer
name: Clinical Trial Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: