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Brief Title: A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer
Official Title: A Phase I Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer
Study ID: NCT02507544
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) and determine the recommended dose and regimen(s) to initiate Phase 2.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
START Midwest, Grand Rapids, Michigan, United States
South Texas Accelerated Research Therapeutics, LLC (START), San Antonio, Texas, United States
Name: Anthony W Tolcher, M.D., FRCP(C)
Affiliation: South Texas Accelerated Research Therapeutics, LLC (START)
Role: PRINCIPAL_INVESTIGATOR
Name: Nehal Lakhani, M.D., Ph.D.
Affiliation: START Midwest
Role: PRINCIPAL_INVESTIGATOR