Phase 1, Open-label, Multiple Dose Escalation Trial to Determine Safety and Tolerability of Once-Daily OPB-51602 in Subjects With Advanced Cancer
This study is based on data that support a role for the signal transducer and activator of
transcription (STAT) family of proteins in oncogenesis. One of the mechanisms of action of
OPB-51602 includes inhibition of STAT3 phosphorylation. Therefore OPB-51602 is expected to
be active as an anti-cancer drug. This first-in-human study will characterize the safety
profile of OPB-51602, evaluate the pharmacokinetics of OPB-51602, identify a recommended
phase II dose, and obtain preliminary efficacy data, in subjects with advanced cancers for
whom there is no standard treatment available.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the safety and tolerability of OPB-51602
AEs, vital signs, body weight, ECGs, clinical laboratory tests, and performance status will be assessed.
Weekly for first cycle, then every 2 weeks (on average up to 8 weeks).
Agnes Elekes, M.D.
Otsuka Pharmaceutical Development & Commercialization, Inc.
United States: Food and Drug Administration
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