Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-02-01 @ 3:14 PM
Study NCT ID:
NCT00115167
Status:
COMPLETED
Last Update Posted:
2009-05-11
First Post:
2005-06-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy', 'Netherlands', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068256', 'term': 'Darbepoetin alfa'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 371}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-07', 'studyFirstSubmitDate': '2005-06-21', 'studyFirstSubmitQcDate': '2005-06-21', 'lastUpdatePostDateStruct': {'date': '2009-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of adverse events', 'timeFrame': 'throughout study'}], 'secondaryOutcomes': [{'measure': 'Confirmed antibody formation to investigational product', 'timeFrame': 'throughout study'}, {'measure': 'Deaths on study', 'timeFrame': 'on study'}, {'measure': 'Laboratory parameters', 'timeFrame': 'throughout study'}, {'measure': 'Vital signs (blood pressure)', 'timeFrame': 'throughout study'}, {'measure': 'Change in PRO scores', 'timeFrame': 'from baseline to end of treatment'}]}, 'conditionsModule': {'keywords': ['Oncology', 'Cancer-related anemia'], 'conditions': ['Anemia', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '18227526', 'type': 'DERIVED', 'citation': 'Smith RE Jr, Aapro MS, Ludwig H, Pinter T, Smakal M, Ciuleanu TE, Chen L, Lillie T, Glaspy JA. Darbepoetin alpha for the treatment of anemia in patients with active cancer not receiving chemotherapy or radiotherapy: results of a phase III, multicenter, randomized, double-blind, placebo-controlled study. J Clin Oncol. 2008 Mar 1;26(7):1040-50. doi: 10.1200/JCO.2007.14.2885. Epub 2008 Jan 28.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}, {'url': 'http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf', 'label': 'Notice regarding posted summaries of trial results'}, {'url': 'http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_33_NESP_20020149.pdf', 'label': 'To access clinical trial results information click on this link'}, {'url': 'http://www.aranesp.com/', 'label': 'FDA-approved Drug Labeling'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety of darbepoetin alfa beyond 16 weeks of treatment in subjects with anemia of cancer who are not receiving chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- Subjects completing the planned 16 weeks of treatment on the 20010103 Anemia of Cancer protocol\n\nExclusion Criteria:\n\n* Subjects currently receiving or planned to receive cytotoxic chemotherapy or myelosuppressive radiotherapy\n* Subjects who have other diagnoses not related to the cancer which can cause anemia\n* Known history of seizure disorder\n* Cardiac condition: uncontrolled angina, congestive heart failure, known ejection fraction less than 40%, or uncontrolled cardiac arrhythmia\n* Uncontrolled hypertension\n* Clinically significant systemic infection or chronic inflammatory disease present at the time of enrollment\n* Subject of reproductive potential who is not using adequate contraceptive precautions\n* Concerns for subject's compliance with the protocol procedures"}, 'identificationModule': {'nctId': 'NCT00115167', 'briefTitle': 'A Study of Darbepoetin Alfa in Anemic Subjects Not Receiving Chemotherapy Who Have Completed the 20010103 Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Multicenter, Randomised, Double-Blind, Placebo-Controlled Roll Over Study to Protocol 20010103 of Darbepoetin Alfa for the Treatment of Anemia of Cancer', 'orgStudyIdInfo': {'id': '20020149'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Darbepoetin alfa', 'interventionNames': ['Drug: Darbepoetin alfa']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Q4W', 'armGroupLabels': ['Placebo']}, {'name': 'Darbepoetin alfa', 'type': 'DRUG', 'description': 'Q4W', 'armGroupLabels': ['Darbepoetin alfa']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Global Development Leader', 'oldOrganization': 'Amgen Inc.'}}}}