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

Xiamen Amoytop Biotech

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Non Small Cell Lung Cancer

Treatments: Drug: YPEG-rhG-CSF, 30μg/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; Drug: YPEG-rhG-CSF, 45μg/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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02005458

TB1309CSF

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

YPEG-rhG-CSF 20μg/kg

Experimental group

Description:

20μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle

Treatment:

Drug: YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle

YPEG-rhG-CSF 30μg/kg

Experimental group

Description:

30μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle

Treatment:

Drug: YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle

YPEG-rhG-CSF 45μg/kg

Experimental group

Description:

45μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle

Treatment:

Drug: YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle

PEG-rhG-CSF 100μg/kg

Active Comparator group

Description:

100μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle

Treatment:

Drug: PEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle