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

PhytoHealth

Status and phase: Completed; Phase 2; Phase 1

Conditions: Neoplasm Recurrence; Neoplasm Metastasis

Treatments: Drug: PG2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01696565

PH-CP002-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

125 mg/day Treatment Arm

Experimental group

Description:

125 mg/day PG2 treatment continuously for 7 days

Treatment:

Drug: PG2

250 mg/day Treatment Arm

Experimental group

Description:

250 mg/day PG2 treatment continuously for 7 days

Treatment:

Drug: PG2

500 mg/day Treatment Arm

Experimental group

Description:

500 mg/day PG2 treatment continuously for 7 days

Treatment:

Drug: PG2