Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-03-04 @ 7:08 PM
Study NCT ID:
NCT02805166
Status:
COMPLETED
Last Update Posted:
2016-06-17
First Post:
2016-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PEG-rhG-CSF in Patients With Malignant Solid Tumors Receiving Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C423652', 'term': 'pegylated granulocyte colony-stimulating factor'}, {'id': 'C455861', 'term': 'pegfilgrastim'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 420}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-16', 'studyFirstSubmitDate': '2016-06-13', 'studyFirstSubmitQcDate': '2016-06-16', 'lastUpdatePostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The occurrence rate of adverse event during at least three consecutive cycles chemotherapy', 'timeFrame': 'up to 30 days after the patient study completion'}, {'measure': 'The severity of adverse event during at least three consecutive cycles chemotherapy', 'timeFrame': 'up to 30 days after the patient study completion'}], 'secondaryOutcomes': [{'measure': 'the non-occurrence rate of grade IV neutropenia (ANC <0.5 x 10^9/L)during at least three consecutive cycles chemotherapy', 'timeFrame': 'through the study completion,an average of 5 months'}, {'measure': 'the duration of grade IV neutropenia(ANC <0.5 x 10^9/L) during at least three consecutive cycles chemotherapy', 'timeFrame': 'through the study completion,an average of 5 months'}]}, 'conditionsModule': {'keywords': ['PEG-rhG-CSF'], 'conditions': ['Malignant Solid Tumors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the safety and efficacy of PEG-rhG-CSF in patients with lung cancer,head and neck cancer,colorectal cancer,and ovarian cancer receiving multi-cycle chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with age ≥ 18 years\n* diagnosis of lung cancer,head and neck cancer,colorectal cancer,ovarian cancer\n* Karnofsky Performance Status ≥ 70\n* life expectancy of at least 3 months\n* Written informed consent are acquired\n\nExclusion Criteria:\n\n* uncontrolled infection,Temperature is 38.0 ℃ or higher\n* pregnancy\n* Other situations that investigators consider as contra-indication for this study'}, 'identificationModule': {'nctId': 'NCT02805166', 'briefTitle': 'PEG-rhG-CSF in Patients With Malignant Solid Tumors Receiving Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.'}, 'officialTitle': 'The Multi-center,Open-label,Single Arm Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Patients With Lung Cancer,Head and Neck Cancer,Colorectal Cancer,Ovarian Cancer and the Other Cancer Receiving Chemotherapy', 'orgStudyIdInfo': {'id': 'CSPC-PGC-IV-01/CSPC-PGC-IV-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEG-rhG-CSF', 'description': 'patients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy.', 'interventionNames': ['Drug: PEG-rhG-CSF']}], 'interventions': [{'name': 'PEG-rhG-CSF', 'type': 'DRUG', 'otherNames': ['pegfilgrastim'], 'armGroupLabels': ['PEG-rhG-CSF']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}