Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT00766116
Status:
COMPLETED
Last Update Posted:
2019-02-18
First Post:
2008-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D000079982', 'term': 'Gemtuzumab'}], 'ancestors': [{'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D000080084', 'term': 'Calicheamicins'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tball@ucsd.edu', 'phone': '858-822-6600', 'title': 'Edward D. Ball, MD', 'organization': 'University of California, San Diego'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': '5-Azacitidine, Gemtuzumab ozogamicin\n\n5-Azacitidine: A = given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit\n\nGemtuzumab ozogamicin: M = Mylotarg given 2 times over 2 weeks', 'otherNumAtRisk': 50, 'otherNumAffected': 44, 'seriousNumAtRisk': 50, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 46, 'numAffected': 38}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gram Positive Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gram Negative Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormalities in liver function tests', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'SIRS/Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 15, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Electrolyte abnormalities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiopulmonary arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fever/pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gram (-) Rods', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea, vomiting, abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalized with syncopal event with intraventricular hemorrhage.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension second to Mylotarg infusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infection documented/ relapsed AML', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenic Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Refractory platlets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'SIRS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 50, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Dose Limiting Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1 Cohort 1', 'description': '5-Azacitidine, Gemtuzumab ozogamicin- Phase 1 Dose Cohort 1: 75 mg/m2 daily for 2 days'}, {'id': 'OG001', 'title': 'Phase 1 Cohort 2', 'description': '5-Azacitidine, Gemtuzumab ozogamicin- Phase 1 Dose Cohort 1: 75 mg/m2 daily for 4 days'}, {'id': 'OG002', 'title': 'Phase 1 Cohort 3', 'description': '5-Azacitidine, Gemtuzumab ozogamicin- Phase 1 Dose Cohort 1: 75 mg/m2 daily for 6 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 28 days', 'description': 'MTD was the maximum number of 5-azacitadine doses (75mg/m2) at which fewer than 1/3 of patients experienced a DLT during cycle 1 of therapy based on CTCAE Version 3.0. In the phase I portion, we assessed 3 dose levels of azacitidine starting on day 1, with 6, 4, and 4 patients in cohort 1, 2, and 3, respectively. We identified no dose-limiting toxicities and identified the phase 2 dose as 75 mg/m2 of 5-azacitadine for 6 days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Response to the Combination Treatment of Mylotarg With 5-azacitidine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': '5-Azacitidine, Gemtuzumab ozogamicin\n\n5-Azacitidine: A = given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit\n\nGemtuzumab ozogamicin: M = Mylotarg given 2 times over 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Hematologic and Cytogeneic Response to treatment will be assessed when evaluated at the time the ANC has reached 1000/mm3 for three consecutive days, assessed up to 4 years', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': '5-Azacitidine, Gemtuzumab ozogamicin\n\n5-Azacitidine: A = given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit\n\nGemtuzumab ozogamicin: M = Mylotarg given 2 times over 2 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': '5-Azacitidine, Gemtuzumab ozogamicin\n\n5-Azacitidine: A = given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit\n\nGemtuzumab ozogamicin: M = Mylotarg given 2 times over 2 weeks'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2014-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2008-10-02', 'resultsFirstSubmitDate': '2018-01-29', 'studyFirstSubmitQcDate': '2008-10-02', 'lastUpdatePostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-01-31', 'studyFirstPostDateStruct': {'date': '2008-10-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Dose Limiting Toxicities', 'timeFrame': 'up to 28 days', 'description': 'MTD was the maximum number of 5-azacitadine doses (75mg/m2) at which fewer than 1/3 of patients experienced a DLT during cycle 1 of therapy based on CTCAE Version 3.0. In the phase I portion, we assessed 3 dose levels of azacitidine starting on day 1, with 6, 4, and 4 patients in cohort 1, 2, and 3, respectively. We identified no dose-limiting toxicities and identified the phase 2 dose as 75 mg/m2 of 5-azacitadine for 6 days.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Response to the Combination Treatment of Mylotarg With 5-azacitidine', 'timeFrame': 'Hematologic and Cytogeneic Response to treatment will be assessed when evaluated at the time the ANC has reached 1000/mm3 for three consecutive days, assessed up to 4 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['AML'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'This study will test an experimental combination of the drugs Mylotarg and 5-azacitidine in the hopes of finding a treatment that may be effective against Acute Myeloid Leukemia that has come back after treatment.', 'detailedDescription': 'In the Phase I portion of the study patients with a diagnosis of AML who have relapsed disease will be treated with an assigned number of doses of 5 azacitidine followed by Mylotarg administered two times over two weeks\n\nIn the Phase II portion of the study patients will be treated with the dose of 5azacitidine determined to be safe in the Phase I portion of the study followed by Mylotarg.\n\nA sample of blood or bone marrow will be obtained prior to initiation of treatment and another sample obtained after treatment with 5-azacitidine but before Mylotarg and the samples will be tested in the laboratory to determine response to treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of Relapsed AML\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2, and life expectancy \\> 3 months\n* ≥ 18 years old\n* Previously untreated for current AML relapse\n* Adequate organ function\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding women\n* Growth factors that support platelet or white cell number or function must not have been administered within the past 7 days\n* Currently receiving another investigational drug\n* Currently receiving other anti-cancer agents\n* Uncontrolled infection\n* HIV positive\n* Received previous therapy with either Mylotarg or 5-azacitidine'}, 'identificationModule': {'nctId': 'NCT00766116', 'briefTitle': 'Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed Acute Myeloid Leukemia (AML)', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'A Phase I/II Trial of the Combination 5-azacitidine and Gemtuzumab Ozogamicin Therapy for Treatment of Relapsed AML', 'orgStudyIdInfo': {'id': '090516'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1 Dose Level 1', 'description': '5-Azacitidine, Gemtuzumab ozogamicin\n\n75 mg/m\\^2 5-Aza 2 days then GO at 3 mg/m\\^2', 'interventionNames': ['Drug: 5-Azacitidine', 'Drug: Gemtuzumab ozogamicin']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 Dose Level 2', 'description': '5-Azacitidine, Gemtuzumab ozogamicin\n\n75mg/m\\^2 5-Aza for 4 days then GO at 6 mg/m\\^2', 'interventionNames': ['Drug: 5-Azacitidine', 'Drug: Gemtuzumab ozogamicin']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I Dose Level 3', 'description': '5-Azacitidine, Gemtuzumab ozogamicin\n\n75 mg/m\\^2 5-Aza for 6 days then GO at 6 mg/m\\^2', 'interventionNames': ['Drug: 5-Azacitidine', 'Drug: Gemtuzumab ozogamicin']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 Dose Level 1', 'description': '5-Azacitidine, Gemtuzumab ozogamicin\n\n75 mg/m\\^2 5-Aza for 6 days then GO at 6 mg/m\\^2', 'interventionNames': ['Drug: 5-Azacitidine', 'Drug: Gemtuzumab ozogamicin']}], 'interventions': [{'name': '5-Azacitidine', 'type': 'DRUG', 'otherNames': ['Vidaz'], 'description': 'Given in cohorts of 3 starting with 2 doses of 5-azacitidine. The doses of 5-azacitidine will be escalated to 4 and then 6 doses if the dose escalation rules permit.', 'armGroupLabels': ['Phase 1 Dose Level 1', 'Phase 1 Dose Level 2', 'Phase 2 Dose Level 1', 'Phase I Dose Level 3']}, {'name': 'Gemtuzumab ozogamicin', 'type': 'DRUG', 'otherNames': ['Mylotarg'], 'description': 'Mylotarg given 2 times over 2 weeks', 'armGroupLabels': ['Phase 1 Dose Level 1', 'Phase 1 Dose Level 2', 'Phase 2 Dose Level 1', 'Phase I Dose Level 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northside Hospital/BMTGA', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Edward D Ball, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'Celgene Corporation', 'class': 'INDUSTRY'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of medicine', 'investigatorFullName': 'Edward Ball', 'investigatorAffiliation': 'University of California, San Diego'}}}}