Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 2:04 AM
Study NCT ID:
NCT03991494
Status:
COMPLETED
Last Update Posted:
2021-09-27
First Post:
2019-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-Pamiparib in Participants With Advanced Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@beigene.com', 'phone': '+1-877-828-5568', 'title': 'Study Director', 'organization': 'BeiGene'}, 'certainAgreement': {'otherDetails': 'BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \\& may request a further delay to protect its IP rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Approximately 30 days after the last dose of pamiparib - up to 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally Treatment phase (Part 2): participants received 60 mg pamiparib twice daily orally', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Plasma Pamiparib Pharmacokinetics: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '29300', 'spread': '21.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7', 'unitOfMeasure': 'hours*nanograms/milliLiter (h*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received one dose of \\[14C\\]-pamiparib and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to Infinity (AUC0-∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally\n\nTreatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'title': 'Plasma Total Radioactivity', 'categories': [{'measurements': [{'value': '42200', 'spread': '21.5', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood Total Radioactivity', 'categories': [{'measurements': [{'value': '32200', 'spread': '16.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7', 'unitOfMeasure': 'h*ngEq/g', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least on dose of \\[14C\\]-pamiparib and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Plasma Pamiparib Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '29200', 'spread': '21.6', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least on dose of \\[14C\\]-pamiparib and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC-t)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'title': 'Plasma Total Radioactivity', 'categories': [{'measurements': [{'value': '41800', 'spread': '21.6', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood Total Radioactivity', 'categories': [{'measurements': [{'value': '31200', 'spread': '16.1', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7', 'unitOfMeasure': 'h*ngEq/g', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least on dose of \\[14C\\]-pamiparib and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Plasma Pamiparib Pharmacokinetics: Maximum Observed Concentration (Cmax) of Pamiparib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally\n\nTreatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '2190', 'spread': '12.4', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least on dose of \\[14C\\]-pamiparib and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Maximum Observed Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally\n\nTreatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'title': 'Plasma Total Radioactivity', 'categories': [{'measurements': [{'value': '2390', 'spread': '9.0', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood Total Radioactivity', 'categories': [{'measurements': [{'value': '1730', 'spread': '11.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7', 'unitOfMeasure': 'ngEq/g', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least on dose of \\[14C\\]-pamiparib and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Plasma Pamiparib Pharmacokinetics: Time of Cmax (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '3.05'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least on dose of \\[14C\\]-pamiparib and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Plasma Total Radioactivity Whole Blood Total Radioactivity Pharmacokinetics: Time of Cmax (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'title': 'Plasma Total Radioactivity', 'categories': [{'measurements': [{'value': '2.25', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '3.05'}]}]}, {'title': 'Whole Blood Total Radioactivity', 'categories': [{'measurements': [{'value': '2.25', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '3.05'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least on dose of \\[14C\\]-pamiparib and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Plasma Pamiparib Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally\n\nTreatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'spread': '6.02', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received one dose of \\[14C\\]-pamiparib and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'title': 'Plasma Total Radioactivity', 'categories': [{'measurements': [{'value': '21.6', 'spread': '10.3', 'groupId': 'OG000'}]}]}, {'title': 'Whole Blood Total Radioactivity', 'categories': [{'measurements': [{'value': '13.3', 'spread': '3.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received one dose of \\[14C\\]-pamiparib and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Plasma Pamiparib Pharmacokinetics: Apparent Total Clearance (CL/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '2.21', 'spread': '23.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7', 'unitOfMeasure': 'Liters/hour (L/h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received one dose of \\[14C\\]-pamiparib and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Plasma Pamiparib Pharmacokinetics: Apparent Volume of Distribution (Vz/F)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally\n\nTreatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '91.3', 'spread': '18.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7', 'unitOfMeasure': 'Liters', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received one dose of \\[14C\\]-pamiparib and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Plasma Pamiparib Pharmacokinetics: AUC0-∞ of Plasma Pamiparib Relative to AUC0-∞ of Plasma Total Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received 60 mg \\[14C\\]-pamiparib twice daily orally\n\nTreatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '0.694', 'spread': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received at least on dose of \\[14C\\]-pamiparib and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Plasma Pharmacokinetics: AUC0-∞ of Whole Blood Total Radioactivity to AUC0-∞ of Plasma Total Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '0.764', 'spread': '5.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received one dose of \\[14C\\]-pamiparib and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Percentage of Total Radioactivity Excreted in Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally\n\nTreatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '57.84', 'spread': '5.12', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '192 hours of [14C]-Pamiparib Administration', 'unitOfMeasure': '% Excreted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received one dose of \\[14C\\]-pamiparib and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Cumulative Urinary Excretion of Pamiparib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally\n\nTreatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '1.095', 'spread': '40.2', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '192 hours of [14C]-Pamiparib Administration', 'unitOfMeasure': 'mg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received one dose of \\[14C\\]-pamiparib and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Renal Clearance of Pamiparib (CLR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03742', 'spread': '59.5', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '192 hours of [14C]-Pamiparib Administration', 'unitOfMeasure': 'CLR (L/h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received one dose of \\[14C\\]-pamiparib and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Fecal Recovery of Total Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally\n\nTreatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '26.89', 'spread': '6.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '192 hours of [14C]-Pamiparib Administration', 'unitOfMeasure': '% Excreted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received one dose of \\[14C\\]-pamiparib and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Cumulative Recovery of Total Radioactivity in Total Excreta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally\n\nTreatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '84.73', 'spread': '3.53', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '192 hours of [14C]-Pamiparib Administration', 'unitOfMeasure': '% Excreted', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received one dose of \\[14C\\]-pamiparib and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events in Part1 and Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'title': 'Part 1: Number of Participants with AEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Part 1: Participants with SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Part 2: Number of Participants with AEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Part 2: Participants with SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'unitOfMeasure': 'number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population for Part 1 consisted of all participants who received 1 dose of study drug, 60 mg \\[14C\\]-pamiparib in Part 1 and the safety population for Part 2 consisted of all participants who participated in Part 1 and received at least 1 dose of 60 mg pamiparib in Part 2.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'unitOfMeasure': 'number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population for Part 1 consisted of all participants who received 1 dose of study drug, 60 mg \\[14C\\]-pamiparib, in Part 1 and the safety population for Part 2 consisted of all participants who participated in Part 1 and received at least 1 dose of 60 mg pamiparib in Part 2.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Abnormalities in 12-lead ECG Parameters, Vital Signs Data, Physical Examinations and Weight Data', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population for Part 1 consisted of all participants who received at least 1 dose of study drug, 60 mg \\[14C\\]-pamiparib, in Part 1 and the safety population for Part 2 consisted of all participants who participated in Part 1 and received at least 1 dose of 60 mg pamiparib in Part 2.'}, {'type': 'SECONDARY', 'title': 'Pamiparib Metabolite Identified and Metabolic Profile Using Measured Mass (M3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'classes': [{'categories': [{'measurements': [{'value': '313.1098', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0.5, 1, 2, 6, 12, 24, 48, 72, 96, 120, and 144 hours post dose on Days 1 to 7', 'description': 'Human plasma, urine, and feces samples were analyzed by LC-MS.', 'unitOfMeasure': 'Da', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all participants who received one dose of \\[14C\\]-pamiparib and had evaluable PK data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The study consisted of 2 parts: a Research Phase (Part 1) in which participants were inpatients and a Treatment Phase (Part 2) in which participants were outpatients.', 'preAssignmentDetails': 'Potential participants were screened to assess their eligibility to enter the study within 28 days prior to administration of the first dose. Up to 10 participants could be enrolled to ensure that 4 participants completed Part 1 of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pamiparib', 'description': 'Research Phase (Part 1): participants received a single dose of 60 mg \\[14C\\]-pamiparib orally Treatment phase (Part 2): participants received pamiparib 60 mg twice daily orally'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'spread': '5.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', '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': '4', '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'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-12', 'size': 1435009, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-02T08:22', 'hasProtocol': True}, {'date': '2019-11-14', 'size': 394680, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-02T08:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2019-06-14', 'resultsFirstSubmitDate': '2021-08-02', 'studyFirstSubmitQcDate': '2019-06-17', 'lastUpdatePostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-30', 'studyFirstPostDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Pamiparib Pharmacokinetics: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞)', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7'}, {'measure': 'Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to Infinity (AUC0-∞)', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7'}, {'measure': 'Plasma Pamiparib Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t)', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7'}, {'measure': 'Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC-t)', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7'}, {'measure': 'Plasma Pamiparib Pharmacokinetics: Maximum Observed Concentration (Cmax) of Pamiparib', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7'}, {'measure': 'Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Maximum Observed Concentration (Cmax)', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7'}, {'measure': 'Plasma Pamiparib Pharmacokinetics: Time of Cmax (Tmax)', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7'}, {'measure': 'Plasma Total Radioactivity Whole Blood Total Radioactivity Pharmacokinetics: Time of Cmax (Tmax)', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7'}, {'measure': 'Plasma Pamiparib Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2)', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7'}, {'measure': 'Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2)', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7'}, {'measure': 'Plasma Pamiparib Pharmacokinetics: Apparent Total Clearance (CL/F)', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7'}, {'measure': 'Plasma Pamiparib Pharmacokinetics: Apparent Volume of Distribution (Vz/F)', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7'}, {'measure': 'Plasma Pamiparib Pharmacokinetics: AUC0-∞ of Plasma Pamiparib Relative to AUC0-∞ of Plasma Total Radioactivity', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7'}, {'measure': 'Plasma Pharmacokinetics: AUC0-∞ of Whole Blood Total Radioactivity to AUC0-∞ of Plasma Total Radioactivity', 'timeFrame': 'Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7'}, {'measure': 'Percentage of Total Radioactivity Excreted in Urine', 'timeFrame': '192 hours of [14C]-Pamiparib Administration'}, {'measure': 'Cumulative Urinary Excretion of Pamiparib', 'timeFrame': '192 hours of [14C]-Pamiparib Administration'}, {'measure': 'Renal Clearance of Pamiparib (CLR)', 'timeFrame': '192 hours of [14C]-Pamiparib Administration'}, {'measure': 'Fecal Recovery of Total Radioactivity', 'timeFrame': '192 hours of [14C]-Pamiparib Administration'}, {'measure': 'Cumulative Recovery of Total Radioactivity in Total Excreta', 'timeFrame': '192 hours of [14C]-Pamiparib Administration'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events in Part1 and Part 2', 'timeFrame': 'Up to 6 months'}, {'measure': 'Number of Participants With Clinically Significant Laboratory Abnormalities', 'timeFrame': 'Up to 6 months'}, {'measure': 'Number of Participants With Clinically Significant Abnormalities in 12-lead ECG Parameters, Vital Signs Data, Physical Examinations and Weight Data', 'timeFrame': 'Up to 6 months'}, {'measure': 'Pamiparib Metabolite Identified and Metabolic Profile Using Measured Mass (M3)', 'timeFrame': '0.5, 1, 2, 6, 12, 24, 48, 72, 96, 120, and 144 hours post dose on Days 1 to 7', 'description': 'Human plasma, urine, and feces samples were analyzed by LC-MS.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumors']}, 'referencesModule': {'references': [{'pmid': '33876576', 'type': 'DERIVED', 'citation': 'Mu S, Palmer D, Fitzgerald R, Andreu-Vieyra C, Zhang H, Tang Z, Su D, Sahasranaman S. Human Mass Balance and Metabolite Profiling of [14 C]-Pamiparib, a Poly (ADP-Ribose) Polymerase Inhibitor, in Patients With Advanced Cancer. Clin Pharmacol Drug Dev. 2021 Sep;10(9):1108-1120. doi: 10.1002/cpdd.943. Epub 2021 Apr 19.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label study, in participants with advanced and/or metastatic solid tumors, which consists of 2 parts: a research phase (inpatient) and a treatment phase. The research phase (Part 1) of the study will assess the disposition of a single oral dose of \\[14C\\]-pamiparib. In the treatment phase (Part 2) participants will be allowed to have continued access to pamiparib.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Histologically and/or cytologically confirmed advanced or metastatic solid tumor that has progressed after treatment with approved therapies for which there are no standard therapies available\n2. A total body weight between 50 and 100 kg, inclusive at Screening\n3. Measurable disease by CT/MRI\n4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1\n5. Adequate organ function\n\nKey Exclusion Criteria:\n\n1. Clinically significant cardiovascular disease\n2. Have a previous complete gastric resection, chronic diarrhea, active inflammatory gastrointestinal disease, or any other disease causing malabsorption syndrome.\n3. Poor peripheral venous access\n4. Major surgical procedure, open biopsy, or significant traumatic injury ≤ 2 weeks prior to Day 1, or anticipation of need for major surgical procedure during the course of the study\n5. Use or have anticipated need for food or drugs known to be strong or moderate CYP3A inhibitors or strong CYP3A inducers\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT03991494', 'briefTitle': 'Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-Pamiparib in Participants With Advanced Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'BeiGene'}, 'officialTitle': 'A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]Pamiparib Following Single Oral Dose Administration in Patients With Advanced and/or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'BGB-290-106'}, 'secondaryIdInfos': [{'id': '2018-001156-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pamiparib', 'interventionNames': ['Drug: [14C]-pamiparib']}], 'interventions': [{'name': '[14C]-pamiparib', 'type': 'DRUG', 'description': 'During the treatment phase, pamiparib 60 mg administered orally twice daily', 'armGroupLabels': ['Pamiparib']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH63 4JY', 'city': 'Bebington', 'state': 'Wirral', 'country': 'United Kingdom', 'facility': 'The Clatterbridge Cancer Centre NHS Foundation Trust', 'geoPoint': {'lat': 53.35, 'lon': -3.01667}}, {'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Royal Liverpool University Hospital Clinical Research Unit', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BeiGene'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BeiGene', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}