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

NCT01696565 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-06-04

No results posted yet for this study

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.

Conditions

  • Neoplasm Metastasis
  • Neoplasm Recurrence

Interventions

DRUG

PG2

Injectable

Sponsors & Collaborators

  • PhytoHealth Corporation

    lead INDUSTRY

Principal Investigators

  • Woei-Yao Kao, Chief · Taichung Tzu Chi Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-12-31
Primary Completion
2003-10-31
Completion
2003-10-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01696565 on ClinicalTrials.gov