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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PhytoHealth Corporation
ClinicalTrials.gov Identifier:
NCT01696565
First received: March 28, 2011
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
  Purpose

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. 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 Intervention Phase
Neoplasm Metastasis
Neoplasm Recurrence
 Drug: PG2
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by PhytoHealth Corporation:

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 [ Time Frame: within 14 days of each chemotherapy cycle ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: within 14 days of each chemotherapy cycle ] [ Designated as safety issue: No ]
    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.


Enrollment: 32
Study Start Date: December 2001
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 125 mg/day Treatment Arm
125 mg/day PG2 treatment continuously for 7 days
 Drug: PG2
Injectable
Other Name: PG2
Experimental: 250 mg/day Treatment Arm
250 mg/day PG2 treatment continuously for 7 days
 Drug: PG2
Injectable
Other Name: PG2
Experimental: 500 mg/day Treatment Arm
500 mg/day PG2 treatment continuously for 7 days
 Drug: PG2
Injectable
Other Name: PG2

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696565

Locations
Taiwan
Tri-Service General Hospital
Taipei, Taiwan, 114
Sponsors and Collaborators
PhytoHealth Corporation
Investigators
Principal Investigator: Woei-Yao WY Kao, Chief Division of Hematology/Oncology, Tri-Service General Hospital
  More Information

No publications provided

Responsible Party: PhytoHealth Corporation
ClinicalTrials.gov Identifier: NCT01696565     History of Changes
Other Study ID Numbers: PH-CP002-2
Study First Received: March 28, 2011
Last Updated: September 27, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by PhytoHealth Corporation:
myelosuppression
chemotherapy
Astragalus membranaceus
hematopoietic response

Additional relevant MeSH terms:
Neoplasms
Neoplasm Metastasis
Recurrence
 Neoplastic Processes
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on May 16, 2013