Status:
COMPLETED
Study of MLN4924, a Novel Inhibitor of Nedd8 Activating Enzyme, in Adult Patients With Lymphoma or Multiple Myeloma
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Hematologic Malignancies
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, multicenter, phase 1, dose escalation study of MLN4924 in adult patients with lymphoma or multiple myeloma. The patient population will consist of adults with a confirmed diagno...
Eligibility Criteria
Inclusion
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Patients must have a confirmed diagnosis of lymphoma (Waldenstrom's macroglobulinemia is permitted) or multiple myeloma that is relapsed and/or refractory after at least 2 prior standard chemotherapeutic regimens and for which no curative option exists.
- 1\. As of Protocol Amendment 7, patients in the expansion cohort, Schedule E, must specifically have Hodgkin lymphoma, DLBCL-GCB subtype, DLBCL-non-GCB subtype, or Mantle Cell Lymphoma (MCL). Patients with multiple myeloma will no longer be evaluated as a part of this study.
- Tumor that is evaluable by radiography, serum or urine electrophoresis (for patients with multiple myeloma), or clinical evaluations.
- 1\. As of Protocol Amendment 7, tumor that is evaluable by radiography or clinical evaluations.
- Suitable venous access for the conduct of blood sampling for MLN4924
- Adequate Organ Function
Exclusion
- Systemic antineoplastic therapy within 21 days preceding first dose of study treatment, or rituximab therapy within 2 months preceding first dose of study treatment (unless there was evidence of PD since their last dose of rituximab).
- Treatment with corticosteroids within 7 days preceding first dose of study treatment.
- Prior treatment with radiation therapy involving \>25% of bone marrow; Any radiotherapy within 14 days before first dose of study treatment.
- Treatment with CYP3A inducers within 14 days before the first dose of MLN4924. Moderate and strong CYP3A inhibitors and CYP3A inducers are not permitted during the study.
- Patients requiring Coumadin who cannot be switched to a low molecular weight heparin should not be considered for this study.
- Absolute neutrophil count less than 1,000/mm3; platelet count less than 75,000/mm3.
- Calculated creatinine clearance less than or equal to 50 mL/minute.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00722488
Start Date
June 1 2008
End Date
September 1 2013
Last Update
November 18 2013
Active Locations (2)
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1
Winship Cancer Institute
Atlanta, Georgia, United States, 30322
2
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263