A Phase I Study of SH003 for Evaluate Safe Dose Range in Patients With Solid Cancer

Summary

A Phase I study of SH003 for evaluate safe dose range in patients with solid cancer. The first dose group receives SH003 for 3 weeks. If the adverse events occur in less than one in six participants, the dose is escalated. The second dose group receives SH003 for 3 weeks. If the adverse events occur in less than one in six participants, the dose is escalated. The third dose group receives SH003 for 3 weeks.

Timeline

Start

2017-03-29

Primary completion

2019-04-16

Completion

2019-07-25

Publications

• Cheon C, Ko SG. A Phase I Study to Evaluate the Safety of the Herbal Medicine SH003 in Patients With Solid Cancer. Integr Cancer Ther. 2020 Jan-Dec;19:1534735420911442. doi: 10.1177/1534735420911442.
• Cheon C, Kang S, Ko Y, Kim M, Jang BH, Shin YC, Ko SG. Single-arm, open-label, dose-escalation phase I study to evaluate the safety of a herbal medicine SH003 in patients with solid cancer: a study protocol. BMJ Open. 2018 Aug 5;8(8):e019502. doi: 10.1136/bmjopen-2017-019502.

Drugs

Indications