This study is an open-label, multicenter, Phase 1, dose escalation study of MLN4924 in adult patients with nonhematologic malignancies. This study will be the first to administer MLN4924 in humans. The patient population will consist of adults with any form of nonhematologic malignancy for which standard, curative, life prolonging, or palliative treatment does not exist or is no longer effective.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
IV dose escalation for 5 consecutive days followed by a rest period of 16 days for a 21 day cycle. Treated may continue until disease progression or unacceptable toxicity develops.
Emory University Hospital
Atlanta, Georgia, United States
Cancer Therapy & Research Center at the UT Health Science Center
San Antonio, Texas, United States
Institute for Drug Development
San Antonio, Texas, United States
Determine the safety profile, MTD and PK/pharmacodynamics of MLN4924
Time frame: Maximum duration of therapy for 12 months
Disease response
Time frame: Day 21, every other cycle and end of study
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