Spots Global Cancer Trial Database for PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

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

Study ID: NCT01696565

Conditions

Neoplasm Metastasis

Neoplasm Recurrence

Interventions

PG2

Study Description

Brief 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.