Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-29 @ 6:25 AM
Study NCT ID:
NCT05976334
Status:
TERMINATED
Last Update Posted:
2025-10-06
First Post:
2023-07-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Absorption, Distribution, Metabolism, Excretion (ADME) Study of [14C]Subasumstat in Adults With Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000730454', 'term': 'TAK-981'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'TrialDisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The enrollment for the study was halted by the sponsor for business reasons.'}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 8 months', 'description': 'SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.', 'eventGroups': [{'id': 'EG000', 'title': '[14C] Subasumstat', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Subasumstat', 'description': 'Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Peripheral venous disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cumulative Percentage of Urinary Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: [14C] Subasumstat', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.87', 'spread': '34.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Up to 14 days post-dose', 'description': 'Cumulative percentage of \\[14C\\]-radioactivity excreted in urine up to the last sampling interval.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.'}, {'type': 'PRIMARY', 'title': 'Cumulative Percentage of Fecal Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: [14C] Subasumstat', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.76', 'spread': '14.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Up to 14 days post-dose', 'description': 'Cumulative percentage of \\[14C\\]-radioactivity excreted in feces up to the last sampling interval.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.'}, {'type': 'PRIMARY', 'title': 'Cumulative Percentage of Combined Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: [14C] Subasumstat', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.27', 'spread': '10.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Up to 14 days post-dose', 'description': 'Cumulative percentage of \\[14C\\]-radioactivity excreted in urine, and feces up to the last sampling interval.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.'}, {'type': 'PRIMARY', 'title': 'Percentage Of Recovered Total Radioactivity (TRA) In Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: [14C] Subasumstat', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.'}], 'classes': [{'title': 'Day 1- 0-6 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.11', 'spread': '41.4', 'groupId': 'OG000'}]}]}, {'title': 'Day 1- 6-12 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.89', 'spread': '36.9', 'groupId': 'OG000'}]}]}, {'title': 'Day 2- 12-24 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.75', 'spread': '31.8', 'groupId': 'OG000'}]}]}, {'title': 'Day 3- 24-48 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': '82.6', 'groupId': 'OG000'}]}]}, {'title': 'Day 4- 48-72 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '74.0', 'groupId': 'OG000'}]}]}, {'title': 'Day 5- 72-96 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '52.4', 'groupId': 'OG000'}]}]}, {'title': 'Day 6- 96-120 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '50.4', 'groupId': 'OG000'}]}]}, {'title': 'Day 7- 120-144 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '48.5', 'groupId': 'OG000'}]}]}, {'title': 'Day 8- 144-168 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '42.1', 'groupId': 'OG000'}]}]}, {'title': 'Day 9- 168-192 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': 'NA', 'comment': 'Geometric coefficient of variation (%CV) was not estimable for a single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Day 10- 192-216 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and %CV were not estimable for dataset containing a data point that equalled zero.', 'groupId': 'OG000'}]}]}, {'title': 'Day 11- 216-240 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and %CV were not estimable for dataset containing a data point that equalled zero.', 'groupId': 'OG000'}]}]}, {'title': 'Day 12- 240-264 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Geometric mean and %CV were not estimable for dataset containing a data point that equalled zero.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Post-dose Day 1: 0-6 hours (hr), 6-12 hr, Day 2: 12-24 hr, Day 3: 24-48 hr, Day 4: 48-72, Day 5: 72-96 hr, Day 6: 96-120 hr, Day 7: 120-144 hr, Day 8: 144-168 hr, Day 9: 168-192 hr, Day 10: 192-216 hr, Day 11: 216-240 hr, Day 12: 240-264 hr', 'description': 'Percentage of recovered TRA in urine for each interval over the entire period of collection were reported.', 'unitOfMeasure': 'mg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug. Number analyzed is the number of participants with data available for analyses at the specified time points.'}, {'type': 'PRIMARY', 'title': 'Percentage Of Recovered Total Radioactivity (TRA) In Feces', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: [14C] Subasumstat', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.'}], 'classes': [{'title': 'Day 1- 0-24 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': 'NA', 'comment': '%CV was not estimable for a single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Day 3- 24-48 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.54', 'spread': '131.6', 'groupId': 'OG000'}]}]}, {'title': 'Day 4- 48-72 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.35', 'spread': '19.5', 'groupId': 'OG000'}]}]}, {'title': 'Day 5- 72-96 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.92', 'spread': 'NA', 'comment': '%CV was not estimable for a single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Day 6- 96-120 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.82', 'spread': '62.4', 'groupId': 'OG000'}]}]}, {'title': 'Day 7- 120-144 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.32', 'spread': '130.0', 'groupId': 'OG000'}]}]}, {'title': 'Day 8- 144-168 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.26', 'spread': '55.3', 'groupId': 'OG000'}]}]}, {'title': 'Day 9- 168-192 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': 'NA', 'comment': '%CV was not estimable for a single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Day 10- 192-216 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': 'NA', 'comment': '%CV was not estimable for a single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Day 11- 216-240 hr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': 'NA', 'comment': '%CV was not estimable for a single participant.', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Post-dose Day 1: 0-6 hours hr, 6-12 hr, Day 2: 12-24 hr, Day 3: 24-48 hr, Day 4: 48-72 hr, Day 5: 72-96 hr, Day 6: 96-120 hr, Day 7: 120-144 hr, Day 8: 144-168 hr, Day 9: 168-192 hr, Day 10: 192-216 hr, Day 11: 216-240 hr', 'description': 'Percentage of recovered TRA in feces for each interval over the entire period of collection were reported.', 'unitOfMeasure': 'mg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug. Number analyzed is the number of participants with data available for analyses at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Cmax: Maximum Observed Plasma Concentration for Subasumstat and TRA in Plasma and Whole Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study. Participants then received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.'}], 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of."}, {'type': 'SECONDARY', 'title': 'Tmax: Time of First Occurrence of Cmax for Subasumstat and TRA in Plasma and Whole Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study. Participants then received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.'}], 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of."}, {'type': 'SECONDARY', 'title': 'AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Subasumstat and TRA in Plasma and Whole Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study. Participants then received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.'}], 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of."}, {'type': 'SECONDARY', 'title': 'Terminal Disposition Phase Half-life (T1/2z) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study. Participants then received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.'}], 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of."}, {'type': 'SECONDARY', 'title': 'Clearance (CL) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study. Participants then received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.'}], 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of."}, {'type': 'SECONDARY', 'title': 'Volume of Distribution at Steady-state (Vss) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study. Participants then received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.'}], 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of."}, {'type': 'SECONDARY', 'title': 'AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study. Participants then received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.'}], 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr 4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of."}, {'type': 'SECONDARY', 'title': 'Cumulative Amount of Unchanged Subasumstat Excreted Into the Urine (Aeurine)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study. Participants then received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '2.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and post-dose at 0-6 hours (hr) and 6-12 hr on Day 1, 12-24 hr on Day 2, 24-48 hr on Day 3, 48-72 hr on Day 4, 72-96 hr on Day 5 up to Day 14', 'description': 'Cumulative amount of unchanged subasumstat was determined as percentage (%) of dose of subasumstat.', 'unitOfMeasure': '% of dose', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.'}, {'type': 'SECONDARY', 'title': 'Renal Clearance (CLR) for Subasumstat in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study. Participants then received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.'}], 'timeFrame': 'Pre-dose and post-dose at 0-6 hours (hr) and 6-12 hr on Day 1, 12-24 hr on Day 2, 24-48 hr on Day 3, 48-72 hr on Day 4, 72-96 hr on Day 5 up to Day 14', 'reportingStatus': 'POSTED', 'populationDescription': "Based on Primary Analysis results, lack of generalizability and accuracy of the urine analysis and missing data for relevant PK parameters, it would not have been possible to report the accurate data without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of."}, {'type': 'SECONDARY', 'title': 'Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: [14C] Subasumstat', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.'}, {'id': 'OG001', 'title': 'Part B: Subasumstat', 'description': 'Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 8 months', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an AE that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With One or More Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: [14C] Subasumstat', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.'}, {'id': 'OG001', 'title': 'Part B: Subasumstat', 'description': 'Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 8 months', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Electrocardiogram Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: [14C] Subasumstat', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.'}, {'id': 'OG001', 'title': 'Part B: Subasumstat', 'description': 'Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 8 months', 'description': 'Abnormal laboratory values are those outside of normal range as assessed by the investigator.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Laboratory Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: [14C] Subasumstat', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.'}, {'id': 'OG001', 'title': 'Part B: Subasumstat', 'description': 'Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.'}], 'classes': [{'title': 'Serum Chemistry', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hematology', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Urinalysis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 8 months', 'description': 'Laboratory findings will include serum chemistry, hematology and urinalysis. Abnormal laboratory values are those outside of normal range as assessed by the investigator.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.'}, {'type': 'SECONDARY', 'title': 'Relative Percentage of Circulatory Metabolites in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study. Participants then received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.'}], 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr and Day 8: 168 hr', 'reportingStatus': 'POSTED', 'populationDescription': "The PK analysis set was planned to include participants with sufficient dosing and PK data to reliably estimate at least one PK parameter. However, due to the low number of participants and missing plasma and whole blood samples for most of them, it would not have been possible to report the data generated from these samples without compromising participant privacy. Therefore, based on the Sponsor's decision, the collected samples were not analyzed and have been disposed of."}, {'type': 'SECONDARY', 'title': 'Relative Percentage Excretory Metabolites in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study. Participants then received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr and Day 8: 168 hr', 'unitOfMeasure': '% of dose', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.'}, {'type': 'SECONDARY', 'title': 'Relative Percentage of Excretory Metabolites in Feces', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Participants', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study. Participants then received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.'}], 'classes': [{'title': 'Metabolite: M1', 'categories': [{'measurements': [{'value': '6.9', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Metabolite: M9', 'categories': [{'measurements': [{'value': '2.5', 'spread': '4.3', 'groupId': 'OG000'}]}]}, {'title': 'Metabolite: M10', 'categories': [{'measurements': [{'value': '12.3', 'spread': '2.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr and Day 8: 168 hr', 'description': 'M1, M9 and M10 reported as categories were the names for the metabolites.', 'unitOfMeasure': '% of dose', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'SAS comprised of participants who had received at least 1 dose, even if incomplete, of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: [14C] Subasumstat', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 milligrams (mg), intravenous (IV) infusion on Day 1 in Part A of the study.'}, {'id': 'FG001', 'title': 'Part B: Subasumstat', 'description': 'Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.'}], 'periods': [{'title': 'Part A', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Part B', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '3 participants took part in the study at 1 investigative site in Hungary from 14 November 2023 to 16 July 2024.', 'preAssignmentDetails': 'Participants with advanced or metastatic solid tumors were enrolled in this study to receive \\[14C\\] subasumstat in Part A and subasumstat in Part B of this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A: [14C] Subasumstat', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 mg, IV infusion on Day 1 in Part A of the study.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.0', 'spread': '12.17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', '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': 'Safety Analysis Set (SAS) comprised of participants who had received at least 1 dose, even if incomplete, of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-25', 'size': 1351569, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-20T09:55', 'hasProtocol': True}, {'date': '2023-06-08', 'size': 1078013, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-06-20T09:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Business reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-12', 'studyFirstSubmitDate': '2023-07-28', 'resultsFirstSubmitDate': '2025-06-20', 'studyFirstSubmitQcDate': '2023-07-28', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-12', 'studyFirstPostDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative Percentage of Urinary Recovery', 'timeFrame': 'Up to 14 days post-dose', 'description': 'Cumulative percentage of \\[14C\\]-radioactivity excreted in urine up to the last sampling interval.'}, {'measure': 'Cumulative Percentage of Fecal Recovery', 'timeFrame': 'Up to 14 days post-dose', 'description': 'Cumulative percentage of \\[14C\\]-radioactivity excreted in feces up to the last sampling interval.'}, {'measure': 'Cumulative Percentage of Combined Recovery', 'timeFrame': 'Up to 14 days post-dose', 'description': 'Cumulative percentage of \\[14C\\]-radioactivity excreted in urine, and feces up to the last sampling interval.'}, {'measure': 'Percentage Of Recovered Total Radioactivity (TRA) In Urine', 'timeFrame': 'Post-dose Day 1: 0-6 hours (hr), 6-12 hr, Day 2: 12-24 hr, Day 3: 24-48 hr, Day 4: 48-72, Day 5: 72-96 hr, Day 6: 96-120 hr, Day 7: 120-144 hr, Day 8: 144-168 hr, Day 9: 168-192 hr, Day 10: 192-216 hr, Day 11: 216-240 hr, Day 12: 240-264 hr', 'description': 'Percentage of recovered TRA in urine for each interval over the entire period of collection were reported.'}, {'measure': 'Percentage Of Recovered Total Radioactivity (TRA) In Feces', 'timeFrame': 'Post-dose Day 1: 0-6 hours hr, 6-12 hr, Day 2: 12-24 hr, Day 3: 24-48 hr, Day 4: 48-72 hr, Day 5: 72-96 hr, Day 6: 96-120 hr, Day 7: 120-144 hr, Day 8: 144-168 hr, Day 9: 168-192 hr, Day 10: 192-216 hr, Day 11: 216-240 hr', 'description': 'Percentage of recovered TRA in feces for each interval over the entire period of collection were reported.'}], 'secondaryOutcomes': [{'measure': 'Cmax: Maximum Observed Plasma Concentration for Subasumstat and TRA in Plasma and Whole Blood', 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr'}, {'measure': 'Tmax: Time of First Occurrence of Cmax for Subasumstat and TRA in Plasma and Whole Blood', 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr'}, {'measure': 'AUClast: Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Subasumstat and TRA in Plasma and Whole Blood', 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr'}, {'measure': 'Terminal Disposition Phase Half-life (T1/2z) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data', 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr'}, {'measure': 'Clearance (CL) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data', 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr'}, {'measure': 'Volume of Distribution at Steady-state (Vss) for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data', 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr,4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr'}, {'measure': 'AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Subasumstat and TRA in Plasma and Whole Blood as Permitted by Data', 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr,1 hr,2 hr 4 hr,8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr, Day 7: 144 hr; Day 8: 168 hr; Day 9: 192 hr,;Day 10: 216 hr; Day 11: 240 hr; Day 12: 264 hr; Day 13: 288 hr; Day 14: 312 hr'}, {'measure': 'Cumulative Amount of Unchanged Subasumstat Excreted Into the Urine (Aeurine)', 'timeFrame': 'Pre-dose and post-dose at 0-6 hours (hr) and 6-12 hr on Day 1, 12-24 hr on Day 2, 24-48 hr on Day 3, 48-72 hr on Day 4, 72-96 hr on Day 5 up to Day 14', 'description': 'Cumulative amount of unchanged subasumstat was determined as percentage (%) of dose of subasumstat.'}, {'measure': 'Renal Clearance (CLR) for Subasumstat in Urine', 'timeFrame': 'Pre-dose and post-dose at 0-6 hours (hr) and 6-12 hr on Day 1, 12-24 hr on Day 2, 24-48 hr on Day 3, 48-72 hr on Day 4, 72-96 hr on Day 5 up to Day 14'}, {'measure': 'Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to approximately 8 months', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A TEAE was defined as an AE that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug.'}, {'measure': 'Number of Participants With One or More Serious Adverse Events (SAEs)', 'timeFrame': 'Up to approximately 8 months', 'description': 'An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.'}, {'measure': 'Number of Participants With Abnormal Electrocardiogram Findings', 'timeFrame': 'Up to approximately 8 months', 'description': 'Abnormal laboratory values are those outside of normal range as assessed by the investigator.'}, {'measure': 'Number of Participants With Abnormal Laboratory Values', 'timeFrame': 'Up to approximately 8 months', 'description': 'Laboratory findings will include serum chemistry, hematology and urinalysis. Abnormal laboratory values are those outside of normal range as assessed by the investigator.'}, {'measure': 'Relative Percentage of Circulatory Metabolites in Plasma', 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr and Day 8: 168 hr'}, {'measure': 'Relative Percentage Excretory Metabolites in Urine', 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr and Day 8: 168 hr'}, {'measure': 'Relative Percentage of Excretory Metabolites in Feces', 'timeFrame': 'Pre-dose and Post-dose Day 1: 0.5 hr, 1 hr, 2 hr, 4 hr, 8 hr; Day 2: 24 hr, Day 3: 48 hr; Day 4:72 hrs; Day 5: 96 hrs; Day 6: 120 hr and Day 8: 168 hr', 'description': 'M1, M9 and M10 reported as categories were the names for the metabolites.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Solid Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.takeda.com/study-detail/8c7f195d5afd4f90?idFilter=%5B%22TAK-981-1004%22%5D', 'label': 'To obtain more information on the study, click this link.'}]}, 'descriptionModule': {'briefSummary': 'The main aim of this study is to assess how the human body of adults with advanced or metastatic solid tumors absorbs, distributes, metabolizes and excretes subasumstat following a single 1 hour infusion of subasumstat.\n\nThe study consists of two parts. In Part A, participants will receive a single infusion of C14 radiolabeled subasumstat. In Part B, participants will receive subasumstat treatment for up to 1 year.', 'detailedDescription': 'The drug being tested in this study is called \\[14C\\]subasumstat. \\[14C\\]Subasumstat is being tested to assess mass balance and absorption, distribution, metabolism, excretion (ADME) of people who have advanced or metastatic solid tumors.\n\nThe study will enroll approximately 10 patients. Participants will be enrolled to receive a single dose of \\[14C\\]subasumstat:\n\n\\- \\[14C\\]Subasumstat 90 mg\n\nParticipants will be administered with a single dose of \\[14C\\]subasumstat 90 mg as a 1-hour intravenous (IV) infusion on Day 1 of Part A. All participants will be monitored for up to 14 days postdose. Participants will then have an option to enter Part B of the study to receive non-radiolabelled subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21-day cycle for 3 cycles up to maximum treatment duration of 1 year.\n\nThis multi-center trial will be conducted in Hungary. The overall study duration is 12 months for Part A and 24 months for Part B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Participants have histologically or cytologically confirmed advanced (locally regionally recurrent not amenable to curative therapy) or metastatic solid tumors with no standard therapeutic option with a proven clinical benefit, are intolerant or have refused them.\n2. Participants have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.\n3. Participants demonstrate adequate organ function.\n4. Participants have recovered to Grade 1 or baseline from all toxicity associated with previous therapy or have the toxicity established as sequela.\n\nKey Exclusion Criteria:\n\n1. Participants received treatment with radioisotopes within 5 half-lives before the first dose of the study drug.\n2. Participants received radiolabelled substances, were exposed to radiation sources within 12 months of the first dose in this study, or is likely to receive radiation exposure or radioisotopes within 12 months of the first dose in this study such that participation in this study would increase their total exposure beyond the recommended safe levels.\n3. Participants received extended field radiotherapy ≤4 weeks before the start of treatment.\n4. Participants have uncontrolled brain metastasis. Participants with treated brain metastases are allowed provided they are radiologically stable, without evidence of progression for at least 4 weeks by repeat imaging, clinically stable, and without requirement of steroid treatment for at least 14 days before first dose of study treatment.\n5. Participants had a second malignancy within the previous 3 years, except treated basal cell or localized squamous skin carcinomas, prostate cancer, cervical carcinoma in situ, resected colorectal adenomatous polyps, breast cancer in situ, or other malignancy for which the patient is not on active anticancer therapies.\n6. Major surgery ≤14 days from the first dose of study drug and not recovered fully from any complications from surgery.\n7. Baseline prolongation of the QT interval when corrected using Fridericia's formula (QTcF).\n8. Receiving or requires the continued use of medications that are known to be strong or moderate inhibitors and inducers of cytochrome P450 (CYP) 3A4/5 and strong P-glycoprotein (Pgp) inhibitors.\n9. Has active noninfectious pneumonitis or interstitial lung disease that required steroids.\n10. History of allogeneic tissue or solid organ transplant.\n11. Participants have active bacterial infection requiring systemic therapy \\<14 days before the start of treatment.\n12. Participants have an active HIV or any other relevant congenital or acquired immunodeficiency.\n13. Active hepatitis B, or hepatitis C infection.\n14. Any of the following uncontrolled heart diseases: congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, uncontrolled hypertension despite appropriate medical therapy, ongoing symptomatic cardiac arrhythmias \\>Grade 2, pulmonary embolism or symptomatic cerebrovascular events, or any other serious cardiac condition (eg, pericardial effusion or restrictive cardiomyopathy). Chronic atrial fibrillation on stable anticoagulant therapy is allowed."}, 'identificationModule': {'nctId': 'NCT05976334', 'briefTitle': 'An Absorption, Distribution, Metabolism, Excretion (ADME) Study of [14C]Subasumstat in Adults With Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase 1 Study to Assess Mass Balance, Pharmacokinetics, and Metabolism of [14C]Subasumstat in Patients With Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'TAK-981-1004'}, 'secondaryIdInfos': [{'id': '2023-503449-79-00', 'type': 'CTIS', 'domain': 'EU CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: [14C] Subasumstat', 'description': 'Participants received a single dose of \\[14C\\] subasumstat 90 milligrams (mg), intravenous (IV) infusion on Day 1 in Part A of the study.', 'interventionNames': ['Drug: [14C] Subasumstat']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Subasumstat', 'description': 'Participants received subasumstat 90 mg, IV infusion on Days 1, 4, 8, and 11 of a 21 day cycle for 3 cycles after Part A, followed by weekly maintenance dosing in Part B of the study up to maximum treatment duration of 1 year.', 'interventionNames': ['Drug: Subasumstat']}], 'interventions': [{'name': '[14C] Subasumstat', 'type': 'DRUG', 'otherNames': ['TAK-981'], 'description': '\\[14C\\] Subasumstat IV infusion.', 'armGroupLabels': ['Part A: [14C] Subasumstat']}, {'name': 'Subasumstat', 'type': 'DRUG', 'otherNames': ['TAK-981'], 'description': 'Subasumstat IV infusion.', 'armGroupLabels': ['Part B: Subasumstat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1062', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Central Hospital of Northern Pest - Military Hospital', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1077', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Pharmaceutical Research Associates Magyarorszag', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be reidentified (due to the limited number of study participants/study sites).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}