Clinical Trial: A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief Summary:

This is a 2-phase study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL), who have already received at least two previous treatments, will receive investigational study drug ARRY-520.

The study has 3 parts. In the first part of the study, Phase 1, patients will receive increasing doses of study drug, with or without granulocyte-colony stimulating factor (G-CSF) support, in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 30 patients from the US will be enrolled in Part 1 (Active, not recruiting).

In the second part of the study, Phase 2, patients will receive the best dose of study drug determined from the first part of the study and will be followed to evaluate what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 30 patients from the US will be enrolled in Part 2 (Active, not recruiting).

In the third part of the study, Phase 2 with Dexamethasone, patients will receive the best dose of the study drug determined from the first part of the study, in combination with dexamethasone, and will be followed to evaluate what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 50 patients from the US will be enrolled in Part 3 (Active, not recruiting).


Detailed Summary:
Sponsor: Array BioPharma

Current Primary Outcome:

  • Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF. [ Time Frame: Part 1 ]
  • Assess the efficacy of the study drug, with and without dexamethasone, in terms of response rate. [ Time Frame: Part 2 and Part 3 ]
  • Characterize the safety profile of the study drug in combination with dexamethasone in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Part 3 ]


Original Primary Outcome:

  • Safety of ARRY-520 as determined by adverse events, dose limiting toxicities (Phase 1 only), clinical laboratory tests (serum chemistry, coagulation panel, blood chemistry), physical examination, body weight and resting, supine 12-lead electrocardiograms [ Time Frame: Duration of study ]
  • Efficacy by serum protein electrophoresis, serum immunofixation electrophoresis, serum free light chain, urine protein electrophoresis, urine immunofixation electrophoresis, bone marrow aspirate/biopsy, CRP, lactate dehydrogenase beta 2 microglobulin [ Time Frame: Every four weeks ]


Current Secondary Outcome:

  • Characterize the pharmacokinetics of the study drug. [ Time Frame: Part 1 ]
  • Assess the efficacy of the study drug in terms of response rate, duration of response, progression-free survival, treatment-free survival and time to next treatment. [ Time Frame: Part 1 ]
  • Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Part 2 ]
  • Assess the efficacy of the study drug, with and without dexamethasone, in terms of duration of response, progression-free survival, treatment-free survival, time to next treatment and overall survival. [ Time Frame: Part 2 and Part 3 ]
  • Explore potential biomarkers for pharmacodynamics (PD) and for patient selection. [ Time Frame: Part 1, Part 2 and Part 3 ]


Original Secondary Outcome:

  • Pharmacokinetics (PK) of ARRY-520 [ Time Frame: Duration of study ]
  • Efficacy as determined by response rate, duration of response, progression-free survival, treatment-free interval, time to next treatment, (Phase 1 and Phase 2) and overall survival (Phase 2 only) [ Time Frame: Duration of study ]
  • Preliminary assessment of the biological activity of kinesin spindle protein (KSP) inhibition in hematological tumor cells and peripheral blood. [ Time Frame: Duration of study ]
  • Measurement of the biological activity of KSP inhibition in hematological tumor cells and peripheral blood [ Time Frame: Duration of study ]


Information By: Array BioPharma

Dates:
Date Received: January 9, 2009
Date Started: January 2009
Date Completion:
Last Updated: April 21, 2016
Last Verified: April 2016