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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00821249
First Posted: January 13, 2009
Last Update Posted: May 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Array BioPharma
January 9, 2009
January 13, 2009
May 19, 2016
January 2009
March 2016   (Final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00821249 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
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A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma
Not Provided

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).

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Multiple Myeloma
  • Plasma Cell Leukemia
  • Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
    Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.
  • Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
    Part 1: standard of care; Part 2: standard of care; Part 3: standard of care.
  • Drug: Dexamethasone, steroid; oral
    Part 3: standard of care.
  • Experimental: ARRY-520
    Intervention: Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
  • Experimental: ARRY-520 + G-CSF support
    Interventions:
    • Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
    • Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
  • Experimental: ARRY-520 + dexamethasone + G-CSF support
    Interventions:
    • Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
    • Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
    • Drug: Dexamethasone, steroid; oral
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
Not Provided
March 2016   (Final data collection date for primary outcome measure)

Key Inclusion Criteria (Part 3):

  • Patients should have received at least two prior treatment regimens.
  • Confirmed refractory MM (measurable disease) or PCL. Patients must be refractory to treatment with both lenalidomide/dexamethasone and bortezomib/dexamethasone (or to treatment with bortezomib/lenalidomide/dexamethasone), defined as documented progressive disease on therapy or within 60 days of completing treatment with these regimens.
  • Previously received adequate alkylator therapy.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Adequate hematology laboratory values without transfusion support within 2 weeks of screening.
  • Adequate liver and renal function.
  • Additional criteria exist.

Key Exclusion Criteria (Part 3):

  • Primary amyloidosis.
  • Concomitant malignancies or previous malignancies with less than a 3-year disease free interval at the time of enrollment (patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or Stage A low grade prostate cancer may enroll irrespective of the time of diagnosis).
  • Autologous or allogeneic stem cell or bone marrow transplant within 3 months prior to first dose of study drug.
  • Cytotoxic therapy or monoclonal antibodies within 21 days prior to first dose of study drug.
  • Radiotherapy within 21 days prior to first dose of study drug (if the radiation portal covered ≤ 5% of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy).
  • Corticosteroid doses > 10 mg/day of prednisone or equivalent within 2 weeks prior to first dose of study drug.
  • Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or active hepatitis C.
  • Additional criteria exist.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00821249
ARRAY-520-212
No
Not Provided
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Array BioPharma
Array BioPharma
Not Provided
Not Provided
Array BioPharma
April 2016

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