Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-28 @ 3:20 AM
Study NCT ID:
NCT01560195
Status:
UNKNOWN
Last Update Posted:
2012-11-06
First Post:
2012-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Pegylated rhG-CSF as Support to Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy Receiving Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D064147', 'term': 'Febrile Neutropenia'}], 'ancestors': [{'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'lastUpdateSubmitDate': '2012-11-04', 'studyFirstSubmitDate': '2012-03-08', 'studyFirstSubmitQcDate': '2012-03-20', 'lastUpdatePostDateStruct': {'date': '2012-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of grade 3/4 neutropenia in cycle 1', 'timeFrame': '21 days', 'description': 'the rate of ANC lower than 1.0 × 109/L'}], 'secondaryOutcomes': [{'measure': 'Incidence of febrile neutropenia in cycle 1', 'timeFrame': '21 days', 'description': 'rate of ANC\\<1.0×109/L and auxiliary temperature\\>38.5℃'}, {'measure': 'Rate of grade 3/4 neutropenia and incidence of febrile neutropenia in cycle 2 to 4', 'timeFrame': 'Through 2 to 4 cycles', 'description': 'The rate of ANC lower than 1.0 × 109 /L and rate of ANC\\<1.0×109/L and auxiliary temperature\\>38.5℃'}, {'measure': 'Time to neutrophil recovery in the 4 chemotherapy cycles', 'timeFrame': 'Through 4 cycles', 'description': "After chemotherapy administration the time from the expected nadir until the patient's ANC increased to 2.0 × 109/L"}, {'measure': 'Duration of 3/4 neutropenia in the 4 chemotherapy cycles', 'timeFrame': 'Through 4 cycles', 'description': 'duration of ANC lower than 1.0 × 109/L'}, {'measure': 'Objective response rate', 'timeFrame': 'Through 4 cycles'}, {'measure': 'Progress free survival', 'timeFrame': 'Through 4 cycles'}, {'measure': 'Overall survival', 'timeFrame': 'Through 4 cycles'}, {'measure': 'Exploratory biomarkers research', 'timeFrame': 'Through 4 cycles', 'description': 'Relationship between SNP and microRNA with myelosuppression and tumor response rate'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neutropenia', 'febrile neutropenia', 'chemotherapy'], 'conditions': ['NSCLC', 'Neutropenia', 'Febrile Neutropenia']}, 'descriptionModule': {'briefSummary': 'Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with advanced NSCLC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Investigator diagnosis of staged III or IV NSCLC\n* Age 18 to 70 years\n* ECOG performance status ≤ 1\n* Chemotherapy naïve\n* Body weight ≥ 45kg\n* Hemoglobin ≥ 100g/L; white blood cell ≥ 4.0×109/L; absolute neutrophil count ≥1.5 × 109/L; platelet count ≥ 100 × 109/L\n* Alanine transarninase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN; total bilirubin ≤1.5×ULN\n\nExclusion Criteria:\n\n* History of systematic chemotherapy or radical radiation therapy\n* Prior bone marrow or stem cell transplantation\n* Received systemic antibiotics treatment within 72 h of chemotherapy\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT01560195', 'briefTitle': 'A Study of Pegylated rhG-CSF as Support to Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy Receiving Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled, Multicenter, Randomized Study Evaluating the Prophylactic Use of Pegylated Recombinant Human Granulocyte Colony Stimulating Factor (rhG-CSF) on the Incidence of Neutropenia in Subjects With Advanced Non-Small-Cell Lung Cancer (NSCLC) Treated With Myelosuppressive Chemotherapy', 'orgStudyIdInfo': {'id': 'HHPG-19K -III-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pegylated rhG-CSF: 100µg/kg', 'description': 'Staged III or IV NSCLC patients receiving chemotherapy and Pegylated rhG-CSF 100µg/kg', 'interventionNames': ['Drug: Pegylated rhG-CSF: 100µg/kg']}, {'type': 'EXPERIMENTAL', 'label': 'Pegylated rhG-CSF: 6mg', 'description': 'Staged III or IV NSCLC patients receiving chemotherapy and pegylated rhG-CSF 6mg', 'interventionNames': ['Drug: Pegylated rhG-CSF: 6mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Staged III or IV NSCLC patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF in cycle 2 to 4', 'interventionNames': ['Drug: placebo and rhG-CSF 5ug/kg/d']}], 'interventions': [{'name': 'Pegylated rhG-CSF: 100µg/kg', 'type': 'DRUG', 'description': 'Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve\\[AUC\\] 5 or cisplatin 75 mg/m2.', 'armGroupLabels': ['Pegylated rhG-CSF: 100µg/kg']}, {'name': 'Pegylated rhG-CSF: 6mg', 'type': 'DRUG', 'description': 'Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve\\[AUC\\] 5 or cisplatin 75 mg/m2.', 'armGroupLabels': ['Pegylated rhG-CSF: 6mg']}, {'name': 'placebo and rhG-CSF 5ug/kg/d', 'type': 'DRUG', 'description': 'Patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF 5ug/kg/d in cycle 2 to 4. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve\\[AUC\\] 5 or cisplatin 75 mg/m2.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Caicun Zhou, M. D.', 'role': 'CONTACT', 'email': 'caicunzhou@yahoo.com.cn'}], 'facility': 'Shanghai Pulmonary Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Caicun Zhou, M. D.', 'role': 'CONTACT', 'email': 'caicunzhou@yahoo.com.cn', 'phone': '862165115006', 'phoneExt': '1053'}, {'name': 'Haoyuan Jiang, Ph. D.', 'role': 'CONTACT', 'email': 'jianghy@shhrp.com', 'phone': '862168868768'}], 'overallOfficials': [{'name': 'Caicun Zhou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Pulmonary Hospital, Shanghai, China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}