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| 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 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 |
| 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 |
Key Inclusion Criteria (Part 3):
Key Exclusion Criteria (Part 3):
Contacts and Locations| Contact: Array BioPharma Clinical Trial Call Center | 303-381-6604 |
| 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 | |
More Information
| 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 |
|
plasma cell dyscrasia plasmacytoma kinesin spindle protein anti-mitotic |
|
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 |