NCT01696565

PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: PhytoHealth Corporation · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this Phase I/II study are: 1. To find out the maximum tolerated dose (MTD) of PG2 in patients with advanced malignancy receiving chemotherapy and to define a "Study Dose" for Phase II. 2. To evaluate the hematopoietic and immunological responses after administering of PG2. Primarily to study the biological response of PG2, defined as WBC count in this study, and secondarily to study the immunological factors, IL-2, IL-6, TGF-beta, and G-CSF.

Detailed description

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.

Conditions

• Neoplasm Metastasis
• Neoplasm Recurrence

Interventions

Type	Name	Description
DRUG	PG2	Injectable

Timeline

• Start date: 2001-12-01
• Primary completion: 2003-10-01
• Completion: 2003-10-01
• First posted: 2012-10-01
• Last updated: 2025-06-04

Locations

1 site across 1 country: Taiwan