CLINICAL TRIAL SUMMARY

MDACC Study No:2008-0135 (clinicaltrials.gov NCT No: NCT00722488)
Title:An Open-Label, Dose Escalation, Phase 1 Study of MLN4924, A Novel Inhibitor of Nedd8-Activating Enzyme, in Adult Patients with Lymphoma or Multiple Myeloma
Principal Investigator:Nathan Fowler
Treatment Agent:MLN4924
Study Status:Terminated
Study Description:The goal of this clinical research study is learn the highest safe dose of
MLN4924 that can be given to patients with lymphoma or MM. How much MLN4924 is
absorbed into the bloodstream and eliminated from the body, how it affects
genes and proteins that are involved in cancer, how it affects its targets in
tumor cells, and how it affects tumor growth will also be studied.

This is the first study using MLN4924 in humans.

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Disease Group:Lymphoma; Myeloma
Phase of Study:Phase I
Treatment Agents:MLN4924
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:The maximum duration of therapy, however, will be 12 months unless it is
determined that a patient would derive
benefit from continued therapy beyond 12 months. It is anticipated that this
study will last
for approximately 30 months.
Supported By:Millennium Pharmaceuticals, Inc.
Return Visit:Schedule A -Days 1, 2, 5, 8, 9, 10, 12, 15 & 21
Schedule B - 1, 2, 4, 8, 11, 12, 15 & 21
Schedule C - 1, 2, 4, 5, 8, 9, 15 & 21
Sch D - 1, 2, 3, 4, 8, 15 & 21

Dosing Days
Schedule A - 1, 2, 8 & 9
Schedule B - 1, 4, 8 & 11
Sch C - 1 & 8
Sch D - 1, 8 & 15
Home Care:None


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Physician Name:Nathan Fowler
Dept:Lymphoma/Myeloma
For Clinical Trial Enrollment:713-792-2860
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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