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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT00821249
First received: January 9, 2009
Last updated: February 13, 2014
Last verified: February 2014
  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 (Active, not 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 1
Phase 2

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
Primary Completion Date: January 2014 (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
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: NCT00821249

Locations
United States, Georgia
Emory University, Winship Cancer Institute
Atlanta, Georgia, United States, 30322
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
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 13, 2014
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, Plasma Cell
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
Leukemia
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 October 01, 2014