Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-26 @ 7:47 AM
Study NCT ID:
NCT01538966
Status:
TERMINATED
Last Update Posted:
2023-01-04
First Post:
2012-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Acromegaly Combination Treatment Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000172', 'term': 'Acromegaly'}, {'id': 'D010900', 'term': 'Pituitary Diseases'}], 'ancestors': [{'id': 'D001849', 'term': 'Bone Diseases, Endocrine'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006964', 'term': 'Hyperpituitarism'}, {'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C406545', 'term': 'pegvisomant'}, {'id': 'D015282', 'term': 'Octreotide'}, {'id': 'C060347', 'term': 'lanreotide'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hwev@cshs.org', 'phone': '424-315-4489', 'title': 'Vivian Hwe', 'organization': 'Cedars-Sinai Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Adverse events were recorded during weekly phone calls with study staff and confirmed at each monthly study visit in person or on the phone.', 'eventGroups': [{'id': 'EG000', 'title': 'High Dose SRL + Weekly Pegvisomant', 'description': 'High dose of SRL monthly\n\n* Octreotide LAR 30mg\n* Lanreotide 120mg\n\nWeekly Pegvisomant (40-120mg/week)', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 4, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Dose SRL + Daily Pegvisomant', 'description': 'Low dose of SRL monthly\n\n* Octreotide LAR 10mg\n* Lanreotide 60mg\n\nDaily Pegvisomant (15-60mg/day)', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 2, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Low Dose SRL + Weekly Pegvisomant', 'description': 'Low dose of SRL monthly\n\n* Octreotide LAR 10mg\n* Lanreotide 60mg\n\nWeekly Pegvisomant (40-120mg/week)', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 9, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Joint pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cost Effectiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose SRL + Weekly Pegvisomant', 'description': 'High dose of SRL monthly\n\n* Octreotide LAR 30mg\n* Lanreotide 120mg\n\nWeekly Pegvisomant (40-120mg/week)'}, {'id': 'OG001', 'title': 'Low Dose SRL + Daily Pegvisomant', 'description': 'Low dose of SRL monthly\n\n* Octreotide LAR 10mg\n* Lanreotide 60mg\n\nDaily Pegvisomant (15-60mg/day)'}, {'id': 'OG002', 'title': 'Low Dose SRL + Weekly Pegvisomant', 'description': 'Low dose of SRL monthly\n\n* Octreotide LAR 10mg\n* Lanreotide 60mg\n\nWeekly Pegvisomant (40-120mg/week)'}], 'classes': [{'categories': [{'measurements': [{'value': '14,261.33', 'spread': '1,645.49', 'groupId': 'OG000'}, {'value': '22,542.86', 'spread': '11,158.49', 'groupId': 'OG001'}, {'value': '9,836.52', 'spread': '1,374.99', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'We evaluated cost-effectiveness of combination low-dose SRL and weekly or daily pegvisomant compared to combination high-dose SRL and weekly pegvisomant by assessing cost of therapy per month in each treatment arm among patients who achieved normal IGF-1 levels.', 'unitOfMeasure': 'US dollars/month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Dose SRL + Weekly Pegvisomant', 'description': 'High dose of SRL monthly\n\n* Octreotide LAR 30mg\n* Lanreotide 120mg\n\nWeekly Pegvisomant (40-120mg/week)'}, {'id': 'FG001', 'title': 'Low Dose SRL + Daily Pegvisomant', 'description': 'Low dose of SRL monthly\n\n* Octreotide LAR 10mg\n* Lanreotide 60mg\n\nDaily Pegvisomant (15-60mg/day)'}, {'id': 'FG002', 'title': 'Low Dose SRL + Weekly Pegvisomant', 'description': 'Low dose of SRL monthly\n\n* Octreotide LAR 10mg\n* Lanreotide 60mg\n\nWeekly Pegvisomant (40-120mg/week)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'High Dose SRL + Weekly Pegvisomant', 'description': 'High dose of SRL monthly\n\n* Octreotide LAR 30mg\n* Lanreotide 120mg\n\nWeekly Pegvisomant (40-120mg/week)'}, {'id': 'BG001', 'title': 'Low Dose SRL + Daily Pegvisomant', 'description': 'Low dose of SRL monthly\n\n* Octreotide LAR 10mg\n* Lanreotide 60mg\n\nDaily Pegvisomant (15-60mg/day)'}, {'id': 'BG002', 'title': 'Low Dose SRL + Weekly Pegvisomant', 'description': 'Low dose of SRL monthly\n\n* Octreotide LAR 10mg\n* Lanreotide 60mg\n\nWeekly Pegvisomant (40-120mg/week)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.6', 'spread': '17.6', 'groupId': 'BG000'}, {'value': '52.9', 'spread': '12.1', 'groupId': 'BG001'}, {'value': '48.0', 'spread': '13.3', 'groupId': 'BG002'}, {'value': '49.5', 'spread': '14.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-09', 'size': 492194, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-18T15:35', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'whyStopped': 'Review of the 12-month data showed patients who deviated from protocol with full IRB monitoring and reporting could not be optimally analyzed. Reopening the study for new enrollment is not feasible and the study was terminated with IRB approval.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-12', 'studyFirstSubmitDate': '2012-02-21', 'resultsFirstSubmitDate': '2022-11-20', 'studyFirstSubmitQcDate': '2012-02-24', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-12-12', 'studyFirstPostDateStruct': {'date': '2012-02-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cost Effectiveness', 'timeFrame': '24 weeks', 'description': 'We evaluated cost-effectiveness of combination low-dose SRL and weekly or daily pegvisomant compared to combination high-dose SRL and weekly pegvisomant by assessing cost of therapy per month in each treatment arm among patients who achieved normal IGF-1 levels.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acromegaly', 'pituitary', 'pegvisomant', 'somavert', 'lanreotide', 'octreotide'], 'conditions': ['Acromegaly']}, 'referencesModule': {'references': [{'pmid': '32754748', 'type': 'RESULT', 'citation': 'Bonert V, Mirocha J, Carmichael J, Yuen KCJ, Araki T, Melmed S. Cost-Effectiveness and Efficacy of a Novel Combination Regimen in Acromegaly: A Prospective, Randomized Trial. J Clin Endocrinol Metab. 2020 Sep 1;105(9):dgaa444. doi: 10.1210/clinem/dgaa444.'}]}, 'descriptionModule': {'briefSummary': 'In this study the investigators will evaluate whether combination low dose somatostatin receptor ligand (SRL) and weekly or daily pegvisomant will attain equivalent control of serum insulin-like growth factor (IGF)-1 levels at a lower cost, compared to combination high dose SRL and weekly pegvisomant. Lower doses of therapy will greatly reduce cost of acromegaly therapy.', 'detailedDescription': 'Subjects will be stratified based on prior response to SRL therapy and then randomized to one of three treatment arms. The study will begin when the combination of octreotide long-acting release (LAR) or lanreotide and pegvisomant is first administered. Study visits will occur every 4 weeks from the start of the study. However, for subjects who cannot make every study visit due to distance, the study team will facilitate monthly blood draws at their local Quest laboratory facility.\n\nAfter the 24 weeks of combination therapy, subjects with a controlled IGF-1 will then start pegvisomant monotherapy at the same dose and schedule that they attained normalization in combination therapy. IGF-1 levels, liver function test, and blood glucose will be performed monthly. Magnetic resonance imaging (MRI) will be performed at the conclusion of the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Newly diagnosed patients with acromegaly who have not had surgery or medical therapy\n* Acromegaly patients who are at least 3 months post surgery, who are/are not receiving adjuvant medical therapy\n* Acromegaly patients on SRL monotherapy with normal or elevated IGF-1 levels\n* Acromegaly patients on Pegvisomant monotherapy with normal or elevated IGF-1 levels.\n* Acromegaly patients who have received SRL and dopamine agonist therapy, after a 6 week washout period of the dopamine agonist.\n* Acromegaly patients on combination therapy with maximum doses of SRL and Pegvisomant (daily or weekly\n* Normal liver function tests before randomization to treatment\n* The patient has had appropriate dynamic testing of the pituitary axis and, if applicable, is receiving appropriate hormone replacement therapy.\n\nExclusion Criteria:\n\n* The patient harbors a macroadenoma with visual field defects due to chiasmatic compression\n* The patient has clinically significant hepatic abnormalities and/or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) above 3 times the upper limit of normal at the baseline visit.\n* The patient had pituitary surgery within 3 months prior to study entry\n* The patient had radiotherapy within 12 months prior to study entry\n* The patient has abnormal CBC and chemistry panel at the baseline visit, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the patient's safety.\n* The patient has a known hypersensitivity to any of the test materials or related compounds.\n* The patient has a history of, or known current problems with alcohol or drug abuse.\n* The patient has any mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the study, and/or evidence of an uncooperative attitude."}, 'identificationModule': {'nctId': 'NCT01538966', 'briefTitle': 'Acromegaly Combination Treatment Study', 'organization': {'class': 'OTHER', 'fullName': 'Cedars-Sinai Medical Center'}, 'officialTitle': 'Comparison of Combination Low-Dose SRL + Daily Pegvisomant Therapy, Low-Dose SRL + Weekly Pegvisomant Therapy, and High-Dose SRL + Weekly Pegvisomant Therapy', 'orgStudyIdInfo': {'id': 'Pro26424'}, 'secondaryIdInfos': [{'id': 'WS2036536', 'type': 'OTHER_GRANT', 'domain': 'Pfizer'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High dose SRL + weekly Pegvisomant', 'description': 'High dose of SRL monthly\n\n* Octreotide LAR 30mg\n* Lanreotide 120mg\n\nWeekly Pegvisomant (40-120mg/week)', 'interventionNames': ['Drug: Pegvisomant', 'Drug: Octreotide LAR', 'Drug: Lanreotide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low dose SRL + daily Pegvisomant', 'description': 'Low dose of SRL monthly\n\n* Octreotide LAR 10mg\n* Lanreotide 60mg\n\nDaily Pegvisomant (15-60mg/day)', 'interventionNames': ['Drug: Pegvisomant', 'Drug: Octreotide LAR', 'Drug: Lanreotide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low dose SRL + weekly Pegvisomant', 'description': 'Low dose of SRL monthly\n\n* Octreotide LAR 10mg\n* Lanreotide 60mg\n\nWeekly Pegvisomant (40-120mg/week)', 'interventionNames': ['Drug: Pegvisomant', 'Drug: Octreotide LAR', 'Drug: Lanreotide']}], 'interventions': [{'name': 'Pegvisomant', 'type': 'DRUG', 'otherNames': ['Somavert'], 'armGroupLabels': ['High dose SRL + weekly Pegvisomant', 'Low dose SRL + daily Pegvisomant', 'Low dose SRL + weekly Pegvisomant']}, {'name': 'Octreotide LAR', 'type': 'DRUG', 'otherNames': ['Sandostatin'], 'armGroupLabels': ['High dose SRL + weekly Pegvisomant', 'Low dose SRL + daily Pegvisomant', 'Low dose SRL + weekly Pegvisomant']}, {'name': 'Lanreotide', 'type': 'DRUG', 'otherNames': ['Somatuline'], 'armGroupLabels': ['High dose SRL + weekly Pegvisomant', 'Low dose SRL + daily Pegvisomant', 'Low dose SRL + weekly Pegvisomant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Shlomo Melmed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cedars-Sinai Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cedars-Sinai Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Executive Vice President, Academic Affairs', 'investigatorFullName': 'Shlomo Melmed, MD', 'investigatorAffiliation': 'Cedars-Sinai Medical Center'}}}}