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Non Small Cell Lung Cancer | Safety and Efficacy of YPEG-rhG-CSF in Cancer Patients Receiving Chemotherapy

Non Small Cell Lung Cancer research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Non Small Cell Lung Cancer

Breast Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

YPEG-rhG-CSF 20μg/kg20μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle

YPEG-rhG-CSF 30μg/kg30μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle

YPEG-rhG-CSF 45μg/kg45μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle

PEG-rhG-CSF 100μg/kg100μg/kg,single s.c. at 48hrs after chemotherapy for each experimental cycle

Study Status

Completed

Start Date: December 2013

Completed Date: February 2018

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome:

Secondary Outcome: Incidence of febrile neutropenia in the two experimental cycles

Study sponsors, principal investigator, and references

Principal Investigator: Yuankai Shi, Ph.D

Lead Sponsor: Xiamen Amoytop Biotech Co., Ltd.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02005458

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