Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT00327535
Status:
COMPLETED
Last Update Posted:
2016-08-11
First Post:
2006-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068256', 'term': 'Darbepoetin alfa'}, {'id': 'C508420', 'term': 'continuous erythropoietin receptor activator'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-09', 'studyFirstSubmitDate': '2006-05-16', 'studyFirstSubmitQcDate': '2006-05-16', 'lastUpdatePostDateStruct': {'date': '2016-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average Hb change from baseline', 'timeFrame': 'Weeks 5-13'}], 'secondaryOutcomes': [{'measure': 'Target Hb therapeutic range, average Hb values, hematopoietic response.', 'timeFrame': 'Days 2-85'}, {'measure': 'Red blood cell (RBC) transfusions', 'timeFrame': 'Weeks 5-13'}, {'measure': 'Adverse events (AEs), laboratory parameters, premature withdrawals', 'timeFrame': 'Throughout study'}]}, 'conditionsModule': {'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': 'This 4 arm study will assess the optimal starting dose of Mircera in the treatment of anemia in patients with non-small cell lung cancer receiving first line myelosuppressive chemotherapy. Patients will be randomized to receive either Mircera 6.3 micrograms/kg, 9 micrograms/kg or 12 micrograms/kg s.c. every 3 weeks or darbepoetin alfa according to the approved local label (either 6.75 micrograms/kg s.c. every 3 weeks, or 2.25 micrograms/kg every week). The anticipated time on study treatment is \\<3 months and the target sample size is 100-500 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>=18 years of age;\n* stage III or IV non-small cell lung cancer receiving first line myelosuppressive chemotherapy;\n* myelosuppressive chemotherapy scheduled for at least 9 weeks;\n* anemia at screening visit.\n\nExclusion Criteria:\n\n* transfusion of red blood cells during the 4 weeks prior to first planned dose of study medication;\n* iron deficiency anemia, or anemia caused by gastrointestinal bleeding;\n* prior treatment with Mircera.'}, 'identificationModule': {'nctId': 'NCT00327535', 'briefTitle': 'A Study of Mircera in Anemic Patients With Non-Small Cell Lung Cancer Receiving First Line Chemotherapy.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Multicenter, Randomized, Open Label Dose Finding Study of Mircera in Anemic Patients With Stage IIIB or IV Non-small Cell Lung Cancer Receiving First Line Myelosuppressive Chemotherapy', 'orgStudyIdInfo': {'id': 'NH19960'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mircera 6.3 micrograms/kg', 'interventionNames': ['Drug: methoxy polyethylene glycol-epoetin beta [Mircera]']}, {'type': 'EXPERIMENTAL', 'label': 'Mircera 9 micrograms/kg', 'interventionNames': ['Drug: methoxy polyethylene glycol-epoetin beta [Mircera]']}, {'type': 'EXPERIMENTAL', 'label': 'Mircera 12 micrograms/kg', 'interventionNames': ['Drug: methoxy polyethylene glycol-epoetin beta [Mircera]']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Darbepoetin alfa', 'interventionNames': ['Drug: Darbepoetin alfa']}], 'interventions': [{'name': 'Darbepoetin alfa', 'type': 'DRUG', 'description': 'According to the approved local label (6.75 micrograms/kg every 3 weeks, or 2.25 micrograms/kg every week)', 'armGroupLabels': ['Darbepoetin alfa']}, {'name': 'methoxy polyethylene glycol-epoetin beta [Mircera]', 'type': 'DRUG', 'description': '6.3 micrograms/kg every 3 weeks', 'armGroupLabels': ['Mircera 6.3 micrograms/kg']}, {'name': 'methoxy polyethylene glycol-epoetin beta [Mircera]', 'type': 'DRUG', 'description': '9 micrograms/kg every 3 weeks', 'armGroupLabels': ['Mircera 9 micrograms/kg']}, {'name': 'methoxy polyethylene glycol-epoetin beta [Mircera]', 'type': 'DRUG', 'description': '12 micrograms/kg every 3 weeks', 'armGroupLabels': ['Mircera 12 micrograms/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'VIC 3165', 'city': 'East Bentleigh', 'country': 'Australia'}, {'zip': '5037', 'city': 'Kurralta Park', 'country': 'Australia', 'geoPoint': {'lat': -34.95142, 'lon': 138.56702}}, {'zip': '4064', 'city': 'Milton', 'country': 'Australia', 'geoPoint': {'lat': -27.47039, 'lon': 153.00312}}, {'zip': '4020', 'city': 'Linz', 'country': 'Austria', 'geoPoint': {'lat': 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