PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01696565|
Recruitment Status : Completed
First Posted : October 1, 2012
Last Update Posted : April 1, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm Metastasis Neoplasm Recurrence||Drug: PG2||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||PG2 Phase I/II Clinical Study Intravenously Administered in Patients With Advanced Malignancy|
|Actual Study Start Date :||December 2001|
|Actual Primary Completion Date :||October 2003|
|Actual Study Completion Date :||October 2003|
Experimental: 125 mg/day Treatment Arm
125 mg/day PG2 treatment continuously for 7 days
Experimental: 250 mg/day Treatment Arm
250 mg/day PG2 treatment continuously for 7 days
Experimental: 500 mg/day Treatment Arm
500 mg/day PG2 treatment continuously for 7 days
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01696565
|Tri-Service General Hospital|
|Taipei, Taiwan, 114|
|Principal Investigator:||Woei-Yao Kao, Chief||Taichung Tzu Chi Hospital|