NCT01696565

Brief Summary

The objectives of this Phase I/II study are:

  1. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

October 1, 2012

Completed
Last Updated

June 4, 2025

Status Verified

June 1, 2025

Enrollment Period

1.8 years

First QC Date

March 28, 2011

Last Update Submit

June 2, 2025

Conditions

Neoplasm MetastasisNeoplasm Recurrence

Keywords

myelosuppressionchemotherapyAstragalus membranaceushematopoietic response

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Phase II: To use the study dose to assess the hematopoietic and immunological cytokine levels

    within 14 days of each chemotherapy cycle

Study Arms (3)

125 mg/day Treatment Arm

EXPERIMENTAL

125 mg/day PG2 treatment continuously for 7 days

Drug: PG2

250 mg/day Treatment Arm

EXPERIMENTAL

250 mg/day PG2 treatment continuously for 7 days

Drug: PG2

500 mg/day Treatment Arm

EXPERIMENTAL

500 mg/day PG2 treatment continuously for 7 days

Drug: PG2

Interventions

PG2DRUG

Injectable

125 mg/day Treatment Arm250 mg/day Treatment Arm500 mg/day Treatment Arm

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient must have malignancy with metastatic or recurrent diseases.
  • Patient must have a minimum of thirteen days period elapsed from any previous chemotherapy or radiotherapy and all treatment-related toxicities subsided.
  • Patient must have at least 2 courses of chemotherapy treatment left, and a minimum of 13 days between the administration of the last dose of the chemotherapy with PG2 and the start of the next course of chemotherapy.
  • Performance status is 0-2 by ECOG scale.
  • Patient's compliance and geographic proximity that allow adequate follow up.
  • Adequate bone marrow function before the chemotherapy
  • Adequate liver and renal function before the chemotherapy
  • Written informed consent from patients
  • Woman with childbearing potential should use contraception method through the whole PG2 treatment course.
  • After the previous course of chemotherapy, the nadir of WBC dropped between 1000 to 3000/ mm3 (for phase II only).

You may not qualify if:

  • PG2 skin test is positive.
  • Active infection
  • Breast feeding
  • Prior radiotherapy more than 30% of the bone marrow involved.
  • Pregnant woman
  • Bone marrow transplantation or brain disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Neoplasm MetastasisRecurrence

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Woei-Yao Kao, Chief

    Taichung Tzu Chi Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2011

First Posted

October 1, 2012

Study Start

December 1, 2001

Primary Completion

October 1, 2003

Study Completion

October 1, 2003

Last Updated

June 4, 2025

Record last verified: 2025-06

Locations

TW(1)