- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01696565
PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy
November 23, 2023 updated by: PhytoHealth Corporation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 114
- Tri-Service General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 125 mg/day Treatment Arm
125 mg/day PG2 treatment continuously for 7 days
|
Injectable
|
Experimental: 250 mg/day Treatment Arm
250 mg/day PG2 treatment continuously for 7 days
|
Injectable
|
Experimental: 500 mg/day Treatment Arm
500 mg/day PG2 treatment continuously for 7 days
|
Injectable
|
What is the study measuring?
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
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. |
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
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.
|
within 14 days of each chemotherapy cycle
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Woei-Yao Kao, Chief, Taichung Tzu Chi Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2001
Primary Completion (Actual)
October 1, 2003
Study Completion (Actual)
October 1, 2003
Study Registration Dates
First Submitted
March 28, 2011
First Submitted That Met QC Criteria
September 27, 2012
First Posted (Estimated)
October 1, 2012
Study Record Updates
Last Update Posted (Actual)
November 27, 2023
Last Update Submitted That Met QC Criteria
November 23, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PH-CP002-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neoplasm Metastasis
-
Betta Pharmaceuticals Co., Ltd.Recruiting
-
BayerCompleted
-
BayerCompletedNeoplasm Metastasis / Bone and BonesBelgium, Spain, Taiwan, United States, Japan, Russian Federation, Canada, Finland, Korea, Republic of, Singapore, Australia, Germany, Israel, United Kingdom, Italy, France, Poland, Brazil, Czechia, Norway, Sweden, Hong Kong
-
National Cancer Institute (NCI)TerminatedCancer | Neoplasm Metastasis | Metastasis | Neoplasm | Radiation OncologyUnited States
-
MedtronicNeuroCompletedMetastasis Spine | Metastasis to BoneUnited States, Luxembourg, Germany, France, Canada
-
Cho Ray HospitalUniversity of Medicine and Pharmacy at Ho Chi Minh CityRecruitingSynchronous Neoplasm | Liver Metastasis Colon CancerVietnam
-
Li MinRecruiting
-
Da FuGanzhou City People's HospitalRecruiting
-
University of Mississippi Medical CenterCompletedMetastasisUnited States
-
Assiut UniversityNot yet recruiting
Clinical Trials on PG2
-
PhytoHealth CorporationCompletedIdiopathic Thrombocytopenic Purpura (ITP)Taiwan
-
PhytoHealth CorporationWithdrawnCancer | Fatigue | SurgeryTaiwan
-
PhytoHealth CorporationTerminatedQuality of Life | Fatigue | ComplementaryTaiwan
-
PhytoHealth CorporationCompleted
-
PhytoHealth CorporationCompleted
-
Taipei Medical UniversityCompleted
-
PhytoHealth CorporationRecruitingCancer-related FatigueTaiwan
-
PhytoHealth CorporationCompletedCancer-related FatigueTaiwan
-
China Medical University HospitalNational Taiwan University Hospital; Shin Kong Wu Ho-Su Memorial Hospital; Taipei... and other collaboratorsCompleted
-
PhytoHealth CorporationActive, not recruitingSurvival | Cancer-related Fatigue | Tumor, EsophagealTaiwan