Neoplasm MetastasisPhase 1/2NCT01696565
PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy
A Phase 1/2 study testing PG2 in people with Neoplasm Metastasis and Neoplasm Recurrence, run by PhytoHealth Corporation at 1 site in Taiwan.
Trial summary
The objectives of this Phase I/II study are: 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. To evaluate the hematopoietic and immunological responses after administering of PG2. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Neoplasm Metastasis, Neoplasm Recurrence
- What is being tested?
- PG2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2001to Oct 2003
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Neoplasm Metastasis, Neoplasm Recurrence
- Being tested
- PG2
- Keywords
- myelosuppression, chemotherapy, Astragalus membranaceus, hematopoietic response
- Medical subject headings
- Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PG2Drug
Injectable
| Study group | Role | What they receive |
|---|---|---|
| 125 mg/day Treatment Arm | Experimental | 125 mg/day PG2 treatment continuously for 7 days Receives: Drug: PG2 |
| 250 mg/day Treatment Arm | Experimental | 250 mg/day PG2 treatment continuously for 7 days Receives: Drug: PG2 |
| 500 mg/day Treatment Arm | Experimental | 500 mg/day PG2 treatment continuously for 7 days Receives: Drug: PG2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: within 14 days of each chemotherapy cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startDec 2001
- Primary completionOct 2003
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhytoHealth Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Woei-Yao Kao, Chief, Principal investigator, Taichung Tzu Chi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696565
- Sponsor's protocol ID
- PH-CP002-2
- Status last verified
- Jun 2025
- First submitted
- 28 Mar 2011
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy
- ClinicalTrials.gov ID
- NCT01696565
- Acronym / sponsor ID
- PH-CP002-2
- Conditions
- Neoplasm Metastasis, Neoplasm Recurrence
- Keywords
- myelosuppression, chemotherapy, Astragalus membranaceus, hematopoietic response
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- PhytoHealth CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2001 (actual)
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 1 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 125 mg/day Treatment Arm | Experimental | Drug: PG2125 mg/day PG2 treatment continuously for 7 days |
| 250 mg/day Treatment Arm | Experimental | Drug: PG2250 mg/day PG2 treatment continuously for 7 days |
| 500 mg/day Treatment Arm | Experimental | Drug: PG2500 mg/day PG2 treatment continuously for 7 days |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (6 listed)
- PG2 skin test is positive.
- Active infection
- Breast feeding
- Prior radiotherapy more than 30% of the bone marrow involved.
- Pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PG2Injectable | Drug | 125 mg/day Treatment Arm, 250 mg/day Treatment Arm, 500 mg/day Treatment Arm |
Primary outcome
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.
1 secondary outcome
Phase II: To use the study dose to assess the hematopoietic and immunological cytokine levels
Time frame: within 14 days of each chemotherapy cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woei-Yao Kao, Chief principal investigator
Taichung Tzu Chi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PG2 in people with Neoplasm Metastasis and Neoplasm Recurrence, run by PhytoHealth Corporation at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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 (time frame: within 14 days of each chemotherapy cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.