Know Cancer

or
forgot password

An Open-Label, Dose Escalation, Phase I Study of MLN4924, a Novel Inhibitor of Nedd8 Activating Enzyme, in Adult Patients With Lymphoma or Multiple Myeloma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Hematologic Malignancies, Multiple Myeloma, Lymphoma, Hodgkin Lymphoma

Thank you

Trial Information

An Open-Label, Dose Escalation, Phase I Study of MLN4924, a Novel Inhibitor of Nedd8 Activating Enzyme, in Adult Patients With Lymphoma or Multiple Myeloma


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of safety and tolerability

Outcome Time Frame:

12 months (maximum duration of therapy)

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C15002

NCT ID:

NCT00722488

Start Date:

June 2008

Completion Date:

January 2015

Related Keywords:

  • Hematologic Malignancies
  • Multiple Myeloma
  • Lymphoma
  • Hodgkin Lymphoma
  • Neoplasms
  • Hodgkin Disease
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Winship Cancer InstituteAtlanta, Georgia  30322