PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy
This study is the first step for PG2 clinical development in Taiwan in order to further
establish its safety and efficacy profile and to build the basis for larger trials.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: To find the maximum tolerated dose (MTD) or the highest tolerated dose (HTD) as the study dose of PG2; Phase II: To use the study dose and assess the WBC level of PG2
For phase I study, the primary endpoint is to determine a safe dosage of PG2 by the dose escalation design. For phase II study, the primary endpoint is to compare the WBC level between PG2 plus chemotherapy and chemotherapy alone.
within 14 days of each chemotherapy cycle
Woei-Yao WY Kao, Chief
Division of Hematology/Oncology, Tri-Service General Hospital
Taiwan: Department of Health