Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-01-07 @ 3:41 AM
Study NCT ID:
NCT02564094
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2015-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C103998', 'term': 'epoetin beta'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2015-09-28', 'studyFirstSubmitQcDate': '2015-09-28', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate according to hemoglobin level', 'timeFrame': 'At Week 4'}, {'measure': 'Transfusion requirement rate', 'timeFrame': 'From Weeks 5 to 12'}, {'measure': 'Predictive value of reticulocyte increase', 'timeFrame': 'At Week 2'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events (AEs)', 'timeFrame': 'Up to approximately 6 months'}]}, 'conditionsModule': {'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy, safety, and pharmacoeconomics of treatment with subcutaneous (SC) epoetin beta (NeoRecormon) in participants with hematologic malignancies or solid tumors. The anticipated time on study treatment is 20 weeks, and the target sample size is 60 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults at least 18 years of age\n* Multiple myeloma (MM), low-grade non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), breast cancer, lung cancer, or ovarian cancer\n* Anemia with low erythropoeitin (EPO) levels\n\nExclusion Criteria:\n\n* Poorly controlled hypertension\n* Relevant acute or chronic bleeding requiring therapy within 3 months before study drug\n* Treatment with EPO within the last 6 weeks\n* Pregnant or breastfeeding females"}, 'identificationModule': {'nctId': 'NCT02564094', 'briefTitle': 'A Study of Epoetin Beta (NeoRecormon) in Participants With Solid Tumors or Hematologic Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Optimizing Treatment of the Anaemia in Onco-Hematological Diseases With NeoRecormon 30,000 IU Once Weekly', 'orgStudyIdInfo': {'id': 'ML18043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epoetin beta', 'description': 'Participants with hematologic or solid malignancies will receive epoetin beta for a treatment period of approximately 20 weeks.', 'interventionNames': ['Drug: Epoetin beta']}], 'interventions': [{'name': 'Epoetin beta', 'type': 'DRUG', 'otherNames': ['NeoRecormon'], 'description': 'Participants will receive SC epoetin beta as 30,000 international units (IU) once weekly for 20 weeks.', 'armGroupLabels': ['Epoetin beta']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Plovdiv', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '4004', 'city': 'Plovdiv', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '1527', 'city': 'Sofia', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1756', 'city': 'Sofia', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1757', 'city': 'Sofia', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1784', 'city': 'Sofia', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '8000', 'city': 'Stara Zagora', 'country': 'Bulgaria', 'geoPoint': {'lat': 42.43205, 'lon': 25.64262}}, {'zip': '9002', 'city': 'Varna', 'country': 'Bulgaria', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}, {'zip': '9010', 'city': 'Varna', 'country': 'Bulgaria', 'geoPoint': {'lat': 43.21912, 'lon': 27.91024}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_CHAIR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}