Safety and Efficacy of YPEG-rhG-CSF in Cancer Patients Receiving Chemotherapy (NCT02005458) | Clinical Trial Compass
CompletedPhase 2
Safety and Efficacy of YPEG-rhG-CSF in Cancer Patients Receiving Chemotherapy
China80 participantsStarted 2013-12
Plain-language 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
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 inve…
What they're measuring
1
Incidence of Grade 3 &4 neutropenia, and median duration of neutropenia in the two experimental cycles