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

Study Overview
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Brief Summary
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The objectives of this Phase I/II study are: 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. 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
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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.

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

Conditions
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Neoplasm Metastasis, Neoplasm Recurrence

Intervention / Treatment
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* Drug: PG2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 125 mg/day Treatment Arm<br>125 mg/day PG2 treatment continuously for 7 days | Drug: PG2<br>* Injectable<br>|
| Experimental: 250 mg/day Treatment Arm<br>250 mg/day PG2 treatment continuously for 7 days | Drug: PG2<br>* Injectable<br>|
| Experimental: 500 mg/day Treatment Arm<br>500 mg/day PG2 treatment continuously for 7 days | Drug: PG2<br>* Injectable<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase II: To use the study dose to assess the hematopoietic and immunological cytokine levels | For phase II study, the secondary endpoint is to compare the levels of IL-2, IL-6, TGF-beta and G-CSF between PG2 plus chemotherapy and chemotherapy alone. | within 14 days of each chemotherapy cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myelosuppression, chemotherapy, Astragalus membranaceus, hematopoietic response