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
  Purpose

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.


Condition Intervention Phase
Advanced Multiple Myeloma
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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 75
Study Start Date: November 2013
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carfilzomib + Filanesib 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 Drug: Carfilzomib, proteasome inhibitor; intravenous
multiple dose, single schedule
Drug: Dexamethasone, steroid; oral or intravenous
as indicated, per the carfilzomib prescribing information

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01989325

Contacts
Contact: Array BioPharma Clinical Trial Call Center 303-381-6604

  Show 19 Study Locations
Sponsors and Collaborators
Array BioPharma
  More Information

Additional Information:
No publications provided

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT01989325     History of Changes
Other Study ID Numbers: ARRAY-520-216
Study First Received: November 5, 2013
Last Updated: July 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
Lenograstim
Proteasome Inhibitors
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on September 18, 2014