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Spots Global Cancer Trial Database for Phase 1, Open-label Trial to Determine Safety of OPB-51602 in Subjects With Advanced Cancer

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Trial Identification

Brief Title: Phase 1, Open-label Trial to Determine Safety of OPB-51602 in Subjects With Advanced Cancer

Official Title: Phase 1, Open-label, Multiple Dose Escalation Trial to Determine Safety and Tolerability of Once-Daily OPB-51602 in Subjects With Advanced Cancer

Study ID: NCT01423903

Conditions

Advanced Cancer

Interventions

OPB-51602

Study Description

Brief Summary: The purpose of this study is to determine whether OPB-51602 is safe and tolerable when given daily by mouth to subjects with advanced solid tumors.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

, Sarasota, Florida, United States

, Boston, Massachusetts, United States

, Nashville, Tennessee, United States

Contact Details

Name: Agnes Elekes, M.D.

Affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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