drugset / Trial / NCT01696565

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

NCT01696565 ↗

Phase 1/2 Completed 32 enrolled PhytoHealth Corporation
Non-randomizedFactorialOpen-labelTreatment

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.

Timeline

Start
2001-12
Primary completion
2003-10
Completion
2003-10

Drugs

EvaluationDrugModalityDoseRoute
Subject PG2 Unknown 125 mg Intravenous
Subject PG2 Unknown 250 mg Intravenous
Subject PG2 Unknown 500 mg Intravenous