Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT03543358
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2018-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Long-Term Study of Rovalpituzumab Tesirine
Sponsor:
Organization:
Raw JSON
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A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to 13.6 months (maximum time on study)', 'eventGroups': [{'id': 'EG000', 'title': 'Arm A: Post-Treatment Follow-Up/Optional Retreatment', 'description': 'Participants who entered the extension study while in post-treatment follow-up of parent study. Participants may receive optional retreatment with rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing) for 2 dose cycles (retreatment may be repeated).', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Receiving Treatment or Retreatment Who Experience a Treatment-Emergent Adverse Event (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A: Post-Treatment Follow-Up/Optional Retreatment', 'description': 'Participants who entered the extension study while in post-treatment follow-up of parent study. Participants may receive optional retreatment with rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing) for 2 dose cycles (retreatment may be repeated).'}], 'timeFrame': 'From first dose of study drug until 70 days following last dose of study drug; up to approximately 5 years.', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either a reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. TEAEs and serious TEAEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on AEs, please see the Adverse Event section.', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants received treatment or retreatment in this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: Post-Treatment Follow-Up/Optional Retreatment', 'description': 'Participants who entered the extension study while in post-treatment follow-up of parent study. Participants may receive optional retreatment with rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing) for 2 dose cycles (retreatment may be repeated).'}, {'id': 'FG001', 'title': 'Arm B: Continued Treatment', 'description': 'Participants who entered the extension study while receiving ongoing rovalpituzumab tesirine treatment plus dexamethasone in the parent study. Participants receive rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) on Day 1 of each 6-week cycle, omitting every third cycle until disease progression or study drug discontinuation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Received Treatment or Retreatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Parent Study Closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This rollover follow-up extension study was conducted in 3 sites in the United States. Participants enrolled while in post-treatment follow-up in parent studies SCRX001-002 (NCT02674568) and SCRX001-007 (NCT02874664).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: Post-Treatment Follow-Up/Optional Retreatment', 'description': 'Participants who entered the extension study while in post-treatment follow-up of parent study. Participants may receive optional retreatment with rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing) for 2 dose cycles (retreatment may be repeated).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.7', 'spread': '6.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-20', 'size': 8532455, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-11-11T17:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT03503890', 'statusForNctId': 'NO_LONGER_AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2018-05-21', 'resultsFirstSubmitDate': '2020-11-11', 'studyFirstSubmitQcDate': '2018-05-21', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-10', 'studyFirstPostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Receiving Treatment or Retreatment Who Experience a Treatment-Emergent Adverse Event (TEAE)', 'timeFrame': 'From first dose of study drug until 70 days following last dose of study drug; up to approximately 5 years.', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either a reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. TEAEs and serious TEAEs are defined as any event that began or worsened in severity after the first dose of study drug. For more details on AEs, please see the Adverse Event section.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rovalpituzumab tesirine', 'rollover study', 'cancer'], 'conditions': ['Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this long-term, extension study is to provide ongoing safety and efficacy follow-up of subjects who participated in a rovalpituzumab tesirine study that has completed the primary analysis and that is closing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject had enrolled, participated in, and received at least 1 dose of rovalpituzumab tesirine in a parent study.\n* Additional eligibility criterion for Arm A: subjects who discontinued the study drug in the parent study have completed the treatment emergent adverse event reporting window.\n\nFor subjects who elect optional retreatment in Arm A, must meet additional criteria before receiving rovalpituzumab tesirine retreatment including:\n\n* Tolerated their initial 2 doses of rovalpituzumab tesirine.\n* Achieved clinical benefit as defined by stable disease or better, and is determined that the subject would potentially benefit from additional treatment.\n* Experienced radiographic disease progression at least 12 weeks after the second dose of rovalpituzumab tesirine.\n* Received no other systemic anti-cancer therapy after rovalpituzumab tesirine treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate hematologic, kidney, and liver function, per protocol.\n* In subjects with central nervous system (CNS) metastases, documentation of stable or improved status as described in the protocol.\n\nExclusion Criteria:\n\n* Subjects not previously enrolled in a rovalpituzumab tesirine study.'}, 'identificationModule': {'nctId': 'NCT03543358', 'briefTitle': 'A Long-Term Study of Rovalpituzumab Tesirine', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Multicenter, Long-Term, Rollover Extension Study of Rovalpituzumab Tesirine', 'orgStudyIdInfo': {'id': 'M16-291'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Post-Treatment Follow-Up/Optional Retreatment', 'description': 'Arm A includes participants who enter the extension study while in post-treatment follow-up. This arm includes optional rovalpituzumab tesirine retreatment plus dexamethasone per participant per retreatment period.', 'interventionNames': ['Drug: rovalpituzumab tesirine']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: Continued Treatment', 'description': 'Arm B includes participants who enter the extension study while receiving ongoing rovalpituzumab tesirine treatment plus dexamethasone in the parent study.', 'interventionNames': ['Drug: rovalpituzumab tesirine']}], 'interventions': [{'name': 'rovalpituzumab tesirine', 'type': 'DRUG', 'otherNames': ['SC16LD6.5'], 'description': 'Optional retreatment with rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing) for 2 dose cycles', 'armGroupLabels': ['Arm A: Post-Treatment Follow-Up/Optional Retreatment']}, {'name': 'rovalpituzumab tesirine', 'type': 'DRUG', 'otherNames': ['SC16LD6.5'], 'description': 'Rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing). Subjects will receive rovalpituzumab tesirine on Day 1 of each 6-week cycle, omitting every third cycle until disease progression or study drug discontinuation.', 'armGroupLabels': ['Arm B: Continued Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Associates, PC-HOPE (Rudasill) /ID# 204818', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91010-3012', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center /ID# 204885', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Univ of Pittsburgh Med Ctr /ID# 204763', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'AbbVie Inc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'url': 'https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.', 'ipdSharing': 'YES', 'description': 'AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}