Safety and Efficacy of YPEG-rhG-CSF in Cancer Patients Receiving Chemotherapy

Study Overview
=================
Brief Summary
-----------------
This study is to examine which dose of YPEG-rhG-CSF, once-per-cycle, has similar efficacy and safety, comparing to PEG-rhG-CSF, once-per-cycle, in chemotherapy-induced neutropenia

Official Title
-----------------
Multi-center, Randomized, Open-labeled, Positive-controlled, Phase Ⅱ Study to Evaluate Efficacy and Safety of YPEG-rhG-CSF, Once-per-cycle, Comparing to PEG-rhG-CSF, Once-per-cycle, in Chemotherapy-induced Neutropenia of Patients With Malignancies Receiving Myelosuppressive Chemotherapy.

Conditions
-----------------
Non Small Cell Lung Cancer, Breast Cancer

Intervention / Treatment
-----------------
* Drug: YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
* Drug: YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
* Drug: YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle
* Drug: PEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of non-small cell lung cancer or Breast cancer, and adequate for carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin chemotherapy Karnofsky Score ≥ 70 Life Expectancy > 3 months Age: 18～70yrs. Peripheral blood test: WBC≥3.5×106/mm3, PLT≥100×106/mm3, ANC≥1.5×106/mm3; Normal bone marrow function; Bone marrow biopsy shows active hematopoietic without cancer cells. Normal coagulation function, no evidences of hemorrhage tendency. No exiting diseases or condition that may influence drug absorption, distribution, metabolism, and excretion. Adequate liver, cardiac, kidney function. Indicators of liver function test ≤ 2.5ULN, Indicators of kidney function test ≤ 1ULN Understand and voluntarily sign an informed consent form. Exclusion Criteria: Pregnant or lactating females Evidence of tumor metastasis in bone marrow Lack insight due to tumor metastasis in the central nervous system Prior bone marrow transplant or stem cell transplant Infective symptom before enrollment into this study Other malignancy history Known hypersensitivity to any component of the drug(e.g. rh-G-CSF) that to be administered Subject enrolled in any other investigational drug or device trial within 3 months of informed consent date Drug abuser or alcoholist Prior radiotherapy or expected to received radiotherapy Unstable or uncontrolled cardiac or hypertension Other conditions which in the opinion of the investigator preclude enrollment into the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YPEG-rhG-CSF 20μg/kg<br>20μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle | Drug: YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle<br> <br> |
| Experimental: YPEG-rhG-CSF 30μg/kg<br>30μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle | Drug: YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle<br> <br> |
| Experimental: YPEG-rhG-CSF 45μg/kg<br>45μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle | Drug: YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle<br> <br> |
| Active Comparator: PEG-rhG-CSF 100μg/kg<br>100μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle | Drug: PEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Grade 3 &4 neutropenia, and median duration of neutropenia in the two experimental cycles | Grade 3 and 4 neutropenia means absolute neutrophil count is less than 1000/mm3 and 500/mm3 , respectively | 21 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of febrile neutropenia in the two experimental cycles | Febrile neutropenia means absolute neutrophil count is less than 500/mm3 or absolute neutrophil count between 500/mm3 and 1000mm3 but probably to decline to less than 500mm3 within 48hrs, and body temperature is higher than 38.5 degrees celsius or higher than 38.0 degrees celsius and lasting for more than 1hr | 21 day | 
| Diversification of neutrophil in the two experimental cycles |  | 21 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neutropenia, Febrile neutropenia, PEG-rhG-CSF, Myelosuppressive chemotherapy