Back to resultsPG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy
Primary Purpose
Neoplasm Metastasis, Neoplasm Recurrence
Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
PG2
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasm Metastasis focused on measuring myelosuppression, chemotherapy, Astragalus membranaceus, hematopoietic response
Eligibility Criteria
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
Sites / Locations
- Tri-Service General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
125 mg/day Treatment Arm
250 mg/day Treatment Arm
500 mg/day Treatment Arm
Arm Description
125 mg/day PG2 treatment continuously for 7 days
250 mg/day PG2 treatment continuously for 7 days
500 mg/day PG2 treatment continuously for 7 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01696565
Brief Title
PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy
Official Title
PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 2001 (Actual)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PhytoHealth Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis, Neoplasm Recurrence
Keywords
myelosuppression, chemotherapy, Astragalus membranaceus, hematopoietic response
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
125 mg/day Treatment Arm
Arm Type
Experimental
Arm Description
125 mg/day PG2 treatment continuously for 7 days
Arm Title
250 mg/day Treatment Arm
Arm Type
Experimental
Arm Description
250 mg/day PG2 treatment continuously for 7 days
Arm Title
500 mg/day Treatment Arm
Arm Type
Experimental
Arm Description
500 mg/day PG2 treatment continuously for 7 days
Intervention Type
Drug
Intervention Name(s)
PG2
Intervention Description
Injectable
Primary Outcome Measure Information:
Title
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
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.
Time Frame
within 14 days of each chemotherapy cycle
Secondary Outcome Measure Information:
Title
Phase II: To use the study dose to assess the hematopoietic and immunological cytokine levels
Description
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.
Time Frame
within 14 days of each chemotherapy cycle
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Woei-Yao Kao, Chief
Organizational Affiliation
Taichung Tzu Chi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan
12. IPD Sharing Statement
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PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy
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