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Brief Title: Safety and Pharmacokinetic Study of TRX-818 in Asian Solid Tumor Patients
Official Title: A Phase I Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Solid Tumors in Asians
Study ID: NCT02703298
Brief Summary: TRX-818 is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. TRX-818 is a potent anti-cancer agent in numerous human cancer cell lines. The objectives of this study are to determine the safety profile of TRX-818 including identification of dose limiting toxicity (DLT) and maximum tolerated dose (MTD) in Asians and determine the recommended dose and regimen(s) to initiate Phase 2.
Detailed Description:
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
National Cheng Kung University Hospital, Tainan City, Tainan, Taiwan
Name: Wu-Chou Su, M.D
Affiliation: National Cheng-Kung University Hospital
Role: PRINCIPAL_INVESTIGATOR