Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT00736333
Status:
COMPLETED
Last Update Posted:
2014-11-05
First Post:
2008-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Safety and Tolerability in Patients With Metastatic Breast Cancer Receiving Treatment With Caelyx (Study P04878)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C506643', 'term': 'liposomal doxorubicin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'title': 'Senior Vice President, Global Cllinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': 'The safety data were from the safety population (those who received at least one dose of study medication).', 'eventGroups': [{'id': 'EG000', 'title': 'Pegylated Liposomal Doxorubicin', 'description': 'Pegylated liposomal doxorubicin 50 mg/m\\^2 given every 4 weeks for up to 6 cycles', 'otherNumAtRisk': 160, 'otherNumAffected': 9, 'seriousNumAtRisk': 160, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 160, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Infusion Reactions (IR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Liposomal Doxorubicin', 'description': 'Pegylated liposomal doxorubicin 50 mg/m\\^2 given every 4 weeks for up to 6 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Week 24', 'description': 'Infusion reaction was defined as an allergic reaction or anaphylactoid reaction characterized by shortness of breath, hypotension, back pain, chest pain, chills, flush, sweating, fever, nausea, dizziness, rash, pruritis, or tachycardia.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population (those who received at least one dose of study medication)'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Complete Response (CR) or Partial Response (PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Liposomal Doxorubicin', 'description': 'Pegylated liposomal doxorubicin 50 mg/m\\^2 given every 4 weeks for up to 6 cycles'}], 'classes': [{'title': 'CR', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'PR', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 24 weeks', 'description': 'CR and PR were documented according to the clinical standards of each site.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (those who received at least one dose of study medication)'}, {'type': 'PRIMARY', 'title': 'Percent of Participants Taking Premedication for Prevention of IR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Liposomal Doxorubicin', 'description': 'Pegylated liposomal doxorubicin 50 mg/m\\^2 given every 4 weeks for up to 6 cycles'}], 'classes': [{'title': 'Corticosteroids', 'categories': [{'measurements': [{'value': '96.3', 'groupId': 'OG000'}]}]}, {'title': 'Serotonin-3 receptor antagonists (anti-emetics)', 'categories': [{'measurements': [{'value': '97.5', 'groupId': 'OG000'}]}]}, {'title': 'Histamine-1 receptor blockers', 'categories': [{'measurements': [{'value': '15.6', 'groupId': 'OG000'}]}]}, {'title': 'Histamine-2 receptor blockers', 'categories': [{'measurements': [{'value': '36.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin', 'description': 'Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers.', 'unitOfMeasure': 'Percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population (those who received at least one dose of study medication)'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Liposomal Doxorubicin', 'description': 'Pegylated liposomal doxorubicin 50 mg/m\\^2 given every 4 weeks for up to 6 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Cycles 1 & 3 (Week 4 & Week 12)', 'description': 'Allergic conditions included food allergies, drug allergies, allergic rhinitis, histamine allergy, neurodermatitis, and chronic idiopathic urticaria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population (those who received at least one dose of study medication)'}, {'type': 'PRIMARY', 'title': 'Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Liposomal Doxorubicin', 'description': 'Pegylated liposomal doxorubicin 50 mg/m\\^2 given every 4 weeks for up to 6 cycles'}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'PPE was defined as a dermatological adverse event characterized by swelling, pain, edema, erythema, desquamation, that may have ultimately resulted in fissuring and ulceration, involving fingers, toes, palms, plantar aspects of the feet, and other pressure-sensitive areas of the skin.', 'unitOfMeasure': 'Occurrences', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population (those who received at least one dose of study medication)'}, {'type': 'PRIMARY', 'title': 'Number of Times Premedications Were Given for Prevention of PPE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pegylated Liposomal Doxorubicin', 'description': 'Pegylated liposomal doxorubicin 50 mg/m\\^2 given every 4 weeks for up to 6 cycles'}], 'classes': [{'title': 'Oral dexamethasone', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'Vitamin B6', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to 24 weeks', 'description': 'Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications.', 'unitOfMeasure': 'Number of times premedication was given', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population (those who received at least one dose of study medication)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pegylated Liposomal Doxorubicin', 'description': 'Pegylated liposomal doxorubicin 50 mg/m\\^2 given every 4 weeks for up to 6 cycles'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '167'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}]}], 'dropWithdraws': [{'type': 'Did Not Receive Drug or Not Documented', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Data Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Tumor Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '75'}]}, {'type': 'Toxicity', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pegylated Liposomal Doxorubicin', 'description': 'Pegylated liposomal doxorubicin 50 mg/m\\^2 given every 4 weeks for up to 6 cycles'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'spread': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age was calculated for the intent-to-treat (ITT) population only (those who received at least one dose of study medication).', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '159', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gender information was available only for the ITT population.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 167}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-31', 'studyFirstSubmitDate': '2008-07-25', 'resultsFirstSubmitDate': '2011-06-13', 'studyFirstSubmitQcDate': '2008-08-14', 'lastUpdatePostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-06-13', 'studyFirstPostDateStruct': {'date': '2008-08-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Infusion Reactions (IR)', 'timeFrame': 'Day 1 up to Week 24', 'description': 'Infusion reaction was defined as an allergic reaction or anaphylactoid reaction characterized by shortness of breath, hypotension, back pain, chest pain, chills, flush, sweating, fever, nausea, dizziness, rash, pruritis, or tachycardia.'}, {'measure': 'Percent of Participants Taking Premedication for Prevention of IR', 'timeFrame': 'Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin', 'description': 'Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers.'}, {'measure': 'Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR', 'timeFrame': 'Cycles 1 & 3 (Week 4 & Week 12)', 'description': 'Allergic conditions included food allergies, drug allergies, allergic rhinitis, histamine allergy, neurodermatitis, and chronic idiopathic urticaria.'}, {'measure': 'Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE)', 'timeFrame': 'Up to 24 weeks', 'description': 'PPE was defined as a dermatological adverse event characterized by swelling, pain, edema, erythema, desquamation, that may have ultimately resulted in fissuring and ulceration, involving fingers, toes, palms, plantar aspects of the feet, and other pressure-sensitive areas of the skin.'}, {'measure': 'Number of Times Premedications Were Given for Prevention of PPE', 'timeFrame': 'Day 1 up to 24 weeks', 'description': 'Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Complete Response (CR) or Partial Response (PR)', 'timeFrame': 'Day 1 up to 24 weeks', 'description': 'CR and PR were documented according to the clinical standards of each site.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Neoplasm']}, 'descriptionModule': {'briefSummary': 'This is a study to evaluate the safety and tolerability of Caelyx used for the treatment of metastatic breast cancer (MBC), focusing on infusion reaction and palmar-plantar erythrodysesthesia (PPE).', 'detailedDescription': 'Patients selected by investigator according to clinical routine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with metastatic breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with metastatic breast cancer\n\nExclusion Criteria:\n\n* History of hypersensitivity to Caelyx or its components\n* Women who are pregnant or breast-feeding\n* Patients with severe myelosuppression'}, 'identificationModule': {'nctId': 'NCT00736333', 'briefTitle': 'A Study to Evaluate Safety and Tolerability in Patients With Metastatic Breast Cancer Receiving Treatment With Caelyx (Study P04878)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Observational Program of Caelyx in MBC - Prevention and Treatment of PPE and Infusion Reactions', 'orgStudyIdInfo': {'id': 'P04878'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pegylated Liposomal Doxorubicin', 'description': 'Subjects with metastatic breast cancer', 'interventionNames': ['Drug: Pegylated Liposomal Doxorubicin']}], 'interventions': [{'name': 'Pegylated Liposomal Doxorubicin', 'type': 'DRUG', 'otherNames': ['SCH 200746'], 'description': 'Pegylated Liposomal Doxorubicin (Caelyx) 50 mg/m\\^2, given for up to 6 cycles', 'armGroupLabels': ['Pegylated Liposomal Doxorubicin']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}