A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Array BioPharma
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT01989325
First received: November 5, 2013
Last updated: July 2, 2014
Last verified: July 2014

November 5, 2013
July 2, 2014
November 2013
April 2015   (final data collection date for primary outcome measure)
Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of progression-free survival. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01989325 on ClinicalTrials.gov Archive Site
  • Assess the efficacy of both carfilzomib + study drug and single-agent carfilzomib in terms of objective response rate. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Following crossover from single-agent carfilzomib, assess the efficacy of carfilzomib + study drug in terms of objective response rate. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Evaluate patient serum levels of alpha 1-acid glycoprotein (AAG) at Baseline and during the treatment period. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
 
A Study of Filanesib (ARRY-520) and Carfilzomib in Patients With Advanced Multiple Myeloma
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Multiple Myeloma
  • Drug: Carfilzomib, proteasome inhibitor; intravenous
    multiple dose, single schedule
  • Drug: Filanesib, KSP(Eg5) inhibitor; intravenous
    multiple dose, single schedule
  • Drug: Dexamethasone, steroid; oral or intravenous
    as indicated, per the carfilzomib prescribing information
  • Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
    standard of care
  • Experimental: Carfilzomib + Filanesib
    Interventions:
    • Drug: Carfilzomib, proteasome inhibitor; intravenous
    • Drug: Filanesib, KSP(Eg5) inhibitor; intravenous
    • Drug: Dexamethasone, steroid; oral or intravenous
    • Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
  • Experimental: Carfilzomib
    Interventions:
    • Drug: Carfilzomib, proteasome inhibitor; intravenous
    • Drug: Dexamethasone, steroid; oral or intravenous
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
Not Provided
April 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Array BioPharma Clinical Trial Call Center 303-381-6604
United States
 
NCT01989325
ARRAY-520-216
No
Array BioPharma
Array BioPharma
Not Provided
Not Provided
Array BioPharma
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP