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

Phase 1/Phase 2
20 Years
75 Years
Not Enrolling
Neoplasm Metastasis, Neoplasm Recurrence

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Trial Information

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

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.

Inclusion Criteria:

- 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).

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

within 14 days of each chemotherapy cycle

Safety Issue:


Principal Investigator

Woei-Yao WY Kao, Chief

Investigator Role:

Principal Investigator

Investigator Affiliation:

Division of Hematology/Oncology, Tri-Service General Hospital


Taiwan: Department of Health

Study ID:




Start Date:

December 2001

Completion Date:

October 2003

Related Keywords:

  • Neoplasm Metastasis
  • Neoplasm Recurrence
  • myelosuppression
  • chemotherapy
  • Astragalus membranaceus
  • hematopoietic response
  • Neoplasms
  • Neoplasm Metastasis
  • Recurrence