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

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.

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

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