PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy
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ClinicalTrials.gov Identifier: NCT01696565 |
Recruitment Status
:
Completed
First Posted
: October 1, 2012
Last Update Posted
: October 1, 2012
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neoplasm Metastasis Neoplasm Recurrence | Drug: PG2 | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Non-Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy |
Study Start Date : | December 2001 |
Actual Primary Completion Date : | October 2003 |
Actual Study Completion Date : | October 2003 |
Arm | Intervention/treatment |
---|---|
Experimental: 125 mg/day Treatment Arm
125 mg/day PG2 treatment continuously for 7 days
|
Drug: PG2
Injectable
|
Experimental: 250 mg/day Treatment Arm
250 mg/day PG2 treatment continuously for 7 days
|
Drug: PG2
Injectable
|
Experimental: 500 mg/day Treatment Arm
500 mg/day PG2 treatment continuously for 7 days
|
Drug: PG2
Injectable
|
- 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 [ Time Frame: within 14 days of each chemotherapy cycle ]
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.
- Phase II: To use the study dose to assess the hematopoietic and immunological cytokine levels [ Time Frame: within 14 days of each chemotherapy cycle ]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.

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Ages Eligible for Study: | 20 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696565
Taiwan | |
Tri-Service General Hospital | |
Taipei, Taiwan, 114 |
Principal Investigator: | Woei-Yao WY Kao, Chief | Division of Hematology/Oncology, Tri-Service General Hospital |
Responsible Party: | PhytoHealth Corporation |
ClinicalTrials.gov Identifier: | NCT01696565 History of Changes |
Other Study ID Numbers: |
PH-CP002-2 |
First Posted: | October 1, 2012 Key Record Dates |
Last Update Posted: | October 1, 2012 |
Last Verified: | September 2012 |
Keywords provided by PhytoHealth Corporation:
myelosuppression chemotherapy Astragalus membranaceus hematopoietic response |
Additional relevant MeSH terms:
Neoplasms Recurrence Neoplasm Metastasis |
Disease Attributes Pathologic Processes Neoplastic Processes |