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A Study of ARRY-520 in Patients With Relapsed or Refractory Multiple Myeloma
This study is currently recruiting participants.
Verified February 2012 by Array BioPharma

First Received on January 9, 2009.   Last Updated on February 1, 2012   History of Changes
Sponsor: Array BioPharma
Information provided by (Responsible Party): Array BioPharma
ClinicalTrials.gov Identifier: NCT00821249
  Purpose

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 (Recruiting).


Condition Intervention Phase
Multiple Myeloma
Plasma Cell Leukemia
Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
Drug: Dexamethasone, steroid; oral
Phase I
Phase II

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

Resource links provided by NLM:


Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • Establish the maximum tolerated dose (MTD) of study drug, with and without G-CSF. [ Time Frame: Part 1 ] [ Designated as safety issue: Yes ]
  • Assess the efficacy of the study drug, with and without dexamethasone, in terms of response rate. [ Time Frame: Part 2 and Part 3 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterize the pharmacokinetics of the study drug. [ Time Frame: Part 1 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Part 2 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Explore potential biomarkers for pharmacodynamics (PD) and for patient selection. [ Time Frame: Part 1, Part 2 and Part 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARRY-520 Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.
Experimental: ARRY-520 + G-CSF support 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.
Experimental: ARRY-520 + dexamethasone + G-CSF support 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821249

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

Locations
United States, Georgia
Emory University, Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Cathy Sharp     404-778-3811     cathysharp@emory.edu    
Principal Investigator: Sagar Lonial, MD            
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Silva Lalo Pregja, MBA     313-576-8673     lalos@karmanos.org    
Principal Investigator: Jeffrey A Zonder, MD            
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Linda Thibodeau     215-728-2207     linda.thibodeau@fccc.edu    
Principal Investigator: Adam Cohen, MD            
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Emily Cao     713-792-2965     etcao@anderson.org    
Principal Investigator: Jatin Shah, MD            
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Kathy Lilleby     206-667-5836     klilleby@fhcrc.org    
Principal Investigator: William Bensinger, MD            
Sponsors and Collaborators
Array BioPharma
  More Information

No publications provided

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT00821249     History of Changes
Other Study ID Numbers: ARRAY-520-212
Study First Received: January 9, 2009
Last Updated: February 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Array BioPharma:
plasma cell dyscrasia
plasmacytoma
kinesin spindle protein
anti-mitotic

Additional relevant MeSH terms:
Leukemia
Leukemia, Plasma Cell
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Lenograstim
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012