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

• Status: Completed
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xiamen Amoytop Biotech Co., Ltd.

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