- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01248923
A Study of ARRY-520 and Bortezomib Plus Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma
This is a Phase 1 study during which patients with relapsed or refractory multiple myeloma (MM) or plasma cell leukemia (PCL) will receive investigational study drug ARRY-520 and bortezomib, with or without dexamethasone, with granulocyte-colony stimulating factor (G-CSF) support.
This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in combination with (1) bortezomib with G-CSF support or (2) bortezomib and dexamethasone with G-CSF support, in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Approximately 45 patients from the US will be enrolled in Part 1 (Active, not recruiting).
In the second part of this study, patients will receive the best dose(s) and schedule(s) of study drug, in combination with bortezomib ± dexamethasone + G-CSF, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Active, not recruiting).
Study Overview
Status
Conditions
Intervention / Treatment
- Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
- Drug: Bortezomib, proteasome inhibitor; intravenous or subcutaneous
- Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
- Drug: ARRY-520, KSP(Eg5) inhibitor; intravenous
- Drug: Bortezomib, proteasome inhibitor; intravenous or subcutaneous
- Drug: Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous
- Drug: Dexamethasone, steroid; oral
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Alabama
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Huntsville, Alabama, United States, 35805
- Clearview Cancer Institute
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Arizona
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Tucson, Arizona, United States, 85715
- Arizona Clinical Research Center, Inc.
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California
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Duarte, California, United States, 91010
- City of Hope
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University, Winship Cancer Institute
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Maryland
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Rockville, Maryland, United States, 20850
- Associates in Oncology/Hematology
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Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, United States, 48201
- Karmanos Cancer Institute
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New York
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New York, New York, United States, 10029
- Mount Sinai Medical Center
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New York, New York, United States, 10016
- NYU Cancer Center
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South Carolina
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Charleston, South Carolina, United States, 29414
- Charleston Hematology Oncology Associates
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Tennessee
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Germantown, Tennessee, United States, 38138
- The Jones Clinic
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Nashville, Tennessee, United States, 37212
- Vanderbilt-Ingram Cancer Center
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Texas
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Dallas, Texas, United States, 75246
- Baylor Charles A. Sammons Cancer Center at Dallas
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria (Part 1 and Part 2):
- Confirmed relapsed or refractory MM (measurable disease) or PCL.
- Prior treatment regimens for Part 1: Patients should have received at least 2 prior treatment regimens. Prior treatment must have included at least one full cycle of a proteasome inhibitor (e.g., bortezomib or carfilzomib) and at least one full cycle of an IMiD (e.g., thalidomide, lenalidomide or pomalidomide).
- Prior treatment regimens for Part 2: Patients should have received 1 to 3 prior treatment regimens. Prior treatment could have included bortezomib only if the disease was not refractory to treatment with bortezomib (refractory defined as documented progression on therapy or within 60 days of completing treatment with bortezomib).
- The disease should have progressed per IMWG criteria during or after the last prior treatment regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Adequate hematology laboratory values without transfusion support and without hematological growth factor support within 2 weeks of screening.
- Adequate liver and renal function.
- Additional criteria exist.
Key Exclusion Criteria (Part 1 and Part 2):
- Primary amyloidosis.
- Peripheral neuropathy ≥ Grade 2 or neuropathy with pain, regardless of grade.
- 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.
- Treatment with an investigational medicinal product or device within 28 days 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).
- Major surgery within 14 days and minor surgery within 7 days prior to first dose of study drug.
- Corticosteroid doses > 10 mg/day of prednisone or equivalent within 14 days 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: ARRY-520 (Schedule 1) + bortezomib + G-CSF
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Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
Part 1: standard of care; Part 2: standard of care determined in Part 1.
Part 1: standard of care; Part 2: standard of care.
Part 1: multiple dose, escalating
Part 1: standard of care
Part 1: standard of care
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EXPERIMENTAL: ARRY-520 (Schedule 1) + bortezomib + dexamethasone + G-CSF
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Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
Part 1: standard of care; Part 2: standard of care determined in Part 1.
Part 1: standard of care; Part 2: standard of care.
Part 1: multiple dose, escalating
Part 1: standard of care
Part 1: standard of care
Part 1: standard of care; Part 2: standard of care determined in Part 1.
|
EXPERIMENTAL: ARRY-520 (Schedule 2) + bortezomib + dexamethasone + G-CSF
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Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
Part 1: standard of care; Part 2: standard of care determined in Part 1.
Part 1: standard of care; Part 2: standard of care.
Part 1: multiple dose, escalating
Part 1: standard of care
Part 1: standard of care
Part 1: standard of care; Part 2: standard of care determined in Part 1.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Characterize the safety profile of the study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time Frame: Part 1
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Part 1
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Establish the maximum tolerated dose (MTD) of the study drug in combination with bortezomib ± dexamethasone + G-CSF.
Time Frame: Part 1
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Part 1
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Assess the efficacy of study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of best overall response
Time Frame: Part 2
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Part 2
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Assess the efficacy of study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of duration of response, time to progression, treatment-free interval and time to next treatment.
Time Frame: Part 1 and Part 2
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Part 1 and Part 2
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Characterize the safety profile of the study drug in combination with bortezomib ± dexamethasone + G-CSF in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time Frame: Part 2
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Part 2
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Assess the pharmacokinetic (PK) drug interactions between ARRY-520 and bortezomib in terms of plasma concentration-time profiles.
Time Frame: Part 2
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Part 2
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Leukemia
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Leukemia, Plasma Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunologic Factors
- Antimitotic Agents
- Mitosis Modulators
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Adjuvants, Immunologic
- Dexamethasone
- Lenograstim
- Bortezomib
- Proteasome Inhibitors
- Filanesib
Other Study ID Numbers
- ARRAY-520-111
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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