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TRX-818 capsules

Anthony W Tolcher, M.D., FRCP(C)

Nehal Lakhani, M.D., Ph.D.

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.

A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer

A Phase I Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer

Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0.

The MTD will be defined as the dose level at which at most one of six patients experiences a DLT after 28 days of treatment have occurred, with the next higher dose having at least 2/3 or 2/6 patients experiencing a DLT.

AUC(0-last): area under the plasma concentration versus time curve to the time of the last measurable concentration; Cmax: maximum plasma concentration; Tmax: time to maximum plasma concentration; T(1/2): terminal elimination half-life

TaiRx, Inc.

Wu-Chou Su, M.D

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.

Safety and Pharmacokinetic Study of TRX-818 in Asian Solid Tumor Patients

A Phase I Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Solid Tumors in Asians

AUC(0-last): area under the plasma concentration versus time curve to the time of the last measurable concentration

Tmax: time to maximum plasma concentration

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer	NCT02507544	Carcinoma Advanced Cancer	TRX-818 capsule...	18 Years -	TaiRx, Inc.
A Safety and Pharmacokinetic Study of TRX-818 Administered Orally to Patients With Advanced Cancer	NCT02507544	Carcinoma Advanced Cancer	TRX-818 capsule...	18 Years -	TaiRx, Inc.
Safety and Pharmacokinetic Study of TRX-818 in Asian Solid Tumor Patients	NCT02703298	Carcinoma Advanced Cancer	TRX-818 capsule...	20 Years -	TaiRx, Inc.

Spots Global Cancer Trial Database for advanced solid malignancy