To Determine the MTD and to Evaluate the Safety, Efficacy and PK Profiles of TSB-9-W1 in Pre-treated Patients With mCRC.

Summary

TSB-9-W1, prepared by Taiwan Sunpan Biotechnology Co., Ltd. (TSB) is a botanical drug and applied patent in the United States (US patent No. 7,138,428 B2), Japan (Patent No. 5441947\) and Taiwan (Patent No. I432191 and I282280). The R\&D laboratory in TSB is ISO/IEC 17025 certified by Taiwan Accreditation Foundation (TAF) and the laboratory number is 2026.The trade name of TSB-9-W1 is "IDS" in English, the registration number is 01472800 at 2011 by Intellectual Property Office (IPO), Taiwan. A phase I and pk study to determine the Maximum Tolerated Dose (MTD) and to evaluate the safety and efficacy profiles of TSB-9-W1 in pre-treated patients with metastatic colorectal cancer (mCRC). there are 5 cohorts and a minimal 2 patients and up to 30 patients are required at phase I. This is a single arm study. All eligible patients with mCRC will receive TSB-9-W1 treatment. Each treatment cycle is composed by a contiguous 2-day oral administration and a contiguous 3-day rest. Patient should take the study drug once daily before meal with approximately 250 ml or appropriate amount of water.

Timeline

Start

2017-07-10

Primary completion

2020-02-12

Completion

2020-08-25

Publications

• Background Le Tourneau C, Lee JJ, Siu LL. Dose escalation methods in phase I cancer clinical trials. J Natl Cancer Inst. 2009 May 20;101(10):708-20. doi: 10.1093/jnci/djp079. Epub 2009 May 12.
• Background Sanoff HK, Sargent DJ, Campbell ME, Morton RF, Fuchs CS, Ramanathan RK, Williamson SK, Findlay BP, Pitot HC, Goldberg RM. Five-year data and prognostic factor analysis of oxaliplatin and irinotecan combinations for advanced colorectal cancer: N9741. J Clin Oncol. 2008 Dec 10;26(35):5721-7. doi: 10.1200/JCO.2008.17.7147. Epub 2008 Nov 10.

Drugs

Indications