Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-03-01 @ 9:20 PM
Study NCT ID:
NCT03427268
Status:
COMPLETED
Last Update Posted:
2021-05-24
First Post:
2017-12-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Trial of PM60184 in Advanced Colorectal Cancer After Standard Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C586200', 'term': 'plocabulin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@pharmamar.com', 'phone': '0034 91846 60 00', 'title': 'Clinical Developtment, Department of PharmaMar´s Oncology, Business Unit.', 'organization': 'Pharmamar, S.A.'}, 'certainAgreement': {'otherDetails': 'The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Patients were assessed between study start date and study completion date, approximately 1 year', 'description': 'Patient excluded for analysis of safety: Two patients were never treated', 'eventGroups': [{'id': 'EG000', 'title': 'PM060184', 'description': 'PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 30, 'seriousNumAtRisk': 30, 'deathsNumAffected': 16, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 14, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Neurotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 52, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 12, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 74, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 66, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 15, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 61, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 33, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 23, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 54, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 11, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 13, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 6, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 26, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'seriousEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pneumonia pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Progression-free Survival Rate at Three Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PM060184', 'description': 'PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).'}], 'classes': [{'categories': [{'measurements': [{'value': '20.7', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '39.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 3 months', 'description': 'Progression-free survival rate at 12 weeks (PFS3), defined as the rate estimate of the percentage of patients who are alive and progression-free at 12 weeks (\\~3 months) after the first treatment administration. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients were never treated; 1 treated patient not receive 2 administrations over 2 cycles.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PM060184', 'description': 'PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).'}], 'classes': [{'categories': [{'measurements': [{'value': '9.8', 'comment': 'not reached', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the first day of treatment to the date of death or last contact, up to 12 months', 'description': 'Overall Survival (OS), defined as the time from the first day of treatment to the date of death or last contact.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients were never treated; 1 treated patient not receive 2 administrations over 2 cycles'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PM060184', 'description': 'PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '2.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 12 months', 'description': 'Progression-free survival (PFS), defined as the time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients were never treated; 1 treated patient not receive 2 administrations over 2 cycles'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PM060184', 'description': 'PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).'}], 'classes': [{'categories': [{'title': 'SD <3 months', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'SD ≥3 months', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'PD', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 12 months', 'description': 'Overall Response Rate defined as the percentage of patients with either complete response (CR) or partial response (PR) according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; RECIST, Response Evaluation Criteria in Solid Tumors', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 patients were never treated; 1 treated patient not receive 2 administrations over 2 cycles'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PM060184', 'description': 'PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'Never treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Compassionate use', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The first informed consent was signed on 16 January 2018 and the first study treatment administration was on 8 February 2018. The cutoff date for the results was 11 February 2019 (date of last follow-up).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'PM060184', 'description': 'PM060184 was administered i.v. via a central line or a peripheral venous catheter (in 30-min administration) at a dose of 9.3 mg/m2 on Day 1 and Day 8 every three weeks (q3wk) (three weeks = one treatment cycle) (dose can be rounded to the first decimal point).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '36', 'upperLimit': '74'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Eastern Cooperative Oncology Group Performance Status', 'classes': [{'categories': [{'title': 'PS 0', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'PS 1', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'PS 0 Fully active able to carry on all pre-disease performance without restriction PS 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature PS 2 Ambulatory and capable of all selfcare but unable to carry out any work activities up and about more than 50% of waking hours PS 3 Capable of only limited selfcare confined to bed or chair more than 50% of waking hours PS 4 Completely disabled cannot carry on any selfcare; totally confined to bed or chair PS 5 Dead', 'unitOfMeasure': 'Participants'}, {'title': 'Stage at diagnosis', 'classes': [{'categories': [{'title': 'Stage I', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Stage IIIB', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Stage IIIC', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Stage IV', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Stage IVA', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Stage IVB', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'UK', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '0:Only in mucosa/inner lining I:Into mucosa/muscular layer. Not into nearby tissue (NT)/lymph nodes (LN) IIA:Into wall. Not into NT/LN IIB:Into layers of muscle to lining of abdomen. Not to nearby LN IIC:Into wall and into nearby structures. Not to nearby LN IIIA:Into inner lining/muscle layers of intestine. Not into other body parts IIIB:Into bowel wall or to surrounding organs and into 1-3 LN or to a nodule of tumor in tissues but not in LN. Not in other body parts IIIC:4+ LN. Not to other body parts IVA:1 distant part of body IVB:\\>1 part of body IVC:Into peritoneum', 'unitOfMeasure': 'Participants'}, {'title': 'Primary tumor side', 'classes': [{'categories': [{'title': 'Left', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Right', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Histology grade at diagnosis', 'classes': [{'categories': [{'title': 'G1: Well differentiated', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'G2: Moderately differentiated', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'G4: Undifferentiated', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'GX: Grade cannot be assessed', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'KRAS mutation status', 'classes': [{'categories': [{'title': 'Mutated', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Not done', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sites involved', 'classes': [{'categories': [{'title': '1 site', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '2 sites', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '3 sites', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '4 sites', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '6 sites', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '7 sites', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Peripheral neuropathy', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior surgery', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior radiotherapy', 'classes': [{'categories': [{'title': 'Concurrent', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Palliative', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior anticancer lines', 'classes': [{'categories': [{'title': '1 line', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '2 lines', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': '3 lines', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Best response to last prior therapy', 'classes': [{'categories': [{'title': 'CR', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'PR', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'SD', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'PD', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'UK', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'CR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; UK,unknown', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'BG000', 'lowerLimit': '39.6', 'upperLimit': '105.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'FULL_RANGE'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '166', 'groupId': 'BG000', 'lowerLimit': '150', 'upperLimit': '183'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'cm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Body surface area', 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'BG000', 'lowerLimit': '1.3', 'upperLimit': '2.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'm^2', 'dispersionType': 'FULL_RANGE'}, {'title': 'Time from diagnosis of advanced disease to study entry', 'classes': [{'categories': [{'measurements': [{'value': '17.3', 'groupId': 'BG000', 'lowerLimit': '5.8', 'upperLimit': '69.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Time from first diagnosis to first PM060184 infusion', 'classes': [{'categories': [{'measurements': [{'value': '22.9', 'groupId': 'BG000', 'lowerLimit': '7.9', 'upperLimit': '57.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Time from prior last progression before study entry', 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '3.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}, {'title': 'Time from stop date of prior chemotherapy to study entry', 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'BG000', 'lowerLimit': '0.1', 'upperLimit': '6.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'months', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-27', 'size': 717629, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-02-18T05:34', 'hasProtocol': True}, {'date': '2018-02-20', 'size': 571509, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-02-18T05:34', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-30', 'studyFirstSubmitDate': '2017-12-20', 'resultsFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2018-02-02', 'lastUpdatePostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-30', 'studyFirstPostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free Survival Rate at Three Months', 'timeFrame': 'Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 3 months', 'description': 'Progression-free survival rate at 12 weeks (PFS3), defined as the rate estimate of the percentage of patients who are alive and progression-free at 12 weeks (\\~3 months) after the first treatment administration. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From the first day of treatment to the date of death or last contact, up to 12 months', 'description': 'Overall Survival (OS), defined as the time from the first day of treatment to the date of death or last contact.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 12 months', 'description': 'Progression-free survival (PFS), defined as the time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Time from the first day of study treatment to the day of assessment of progression, death or last tumor evaluation, up to 12 months', 'description': 'Overall Response Rate defined as the percentage of patients with either complete response (CR) or partial response (PR) according to RECIST v.1.1.\n\nCR, complete response: disappearance of all lesions; PD, disease progression: ≥10% increase in target lesion size and does not meet tumor density criteria of PR density; PR, partial response: ≥10% decrease in target lesion size or ≥15% decrease in tumor density; SD, stable disease: none of the CR, PR, or PD criteria met; RECIST, Response Evaluation Criteria in Solid Tumors'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This trial will evaluate the efficacy of PM060184 in terms of progression-free survival at 12 weeks (PFS3) in advanced or metastatic Colorectal Cancer (CRC) patients with any KRAS mutation status (wild- type; mutated; or unknown status) progressing after standard treatments (fluoropyrimidine, irinotecan, and oxaliplatin).\n\nPatients in this trial will receive PM060184 at a dose of 9.3 mg/m2 as a 30-minute intravenous (i.v.) infusion on Days 1 and 8 q3wk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "INCLUSION CRITERIA:\n\n1. Voluntarily written informed consent, obtained before the beginning of any study-specific procedures.\n2. Age ≥ 18 years.\n3. Histologically-cytologically documented adenocarcinoma of colon or rectum that has progressed to the last prior treatment before inclusion.\n4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1. If the only tumor lesion is situated in a previously irradiated area or in an area subjected to other loco-regional therapy, regression in the lesion must be demonstrated radiologically.\n5. Previous treatment in any setting with fluoropyrimidine, oxaliplatin and irinotecan in any combination (unless any is contraindicated).\n\n 1. Adjuvant chemotherapy-based treatments count as prior therapy, as long as relapse had occurred during or within six months of completion of such therapies.\n 2. Cumulative dose of prior oxaliplatin (if any) must be known.\n 3. Prior cetuximab, panitumumab, bevacizumab, aflibercept, and regorafenib are allowed.\n6. No more than two prior therapies for metastatic disease.\n7. Washout periods for prior therapies (defined in relation to planned start of study treatment \\[first dose administration\\]):\n\n 1. At least three weeks since the last administration of an antineoplastic treatment (chemotherapy, biological, targeted or investigational therapies).\n 2. At least three weeks since radiotherapy involving up to 35% of bone marrow (radiotherapy involving \\> 35% of bone marrow is not allowed) or two weeks since the end of palliative radiotherapy including single doses.\n 3. At least four weeks since any major surgical procedure, open biopsy, or significant traumatic injury.\n8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.\n9. Life expectancy ≥ 3 months.\n10. Adequate bone marrow, liver, and kidney function:\n\n 1. Hemoglobin ≥ 9 g/dL.\n 2. Absolute neutrophil count ≥ 1.5 × 109/L.\n 3. Platelet count ≥ 100 × 109/L.\n 4. Serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault formula).\n 5. Albumin ≥ 2.5 g/dL.\n 6. Total serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), except in case of Gilbert syndrome.\n 7. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN (≤ 5.0 × ULN in the case of liver metastases).\n11. Recovery to grade ≤ 1 from any toxicity due to previous therapy (including peripheral sensory/motor neuropathy but excluding alopecia).\n12. Left ventricular ejection fraction (LVEF) by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan within normal range (according to institutional standards).\n13. Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure during the trial and up to six months after treatment discontinuation, and fertile male patients must agree to refrain from fathering a child or donating sperm during the trial and up to four months after treatment discontinuation.\n\nEXCLUSION CRITERIA:\n\n1. Prior exposure to PM060184.\n2. Known hypersensitivity to the study drug class or study drug excipient in the formulation.\n3. Patients with locally advanced disease amenable to local and/or curative therapy (surgery or radiotherapy) at study entry.\n4. Other serious and/or relevant diseases or clinical situations that, in the opinion of the Investigator, are incompatible with the protocol (including any of the following):\n\n 1. History of another neoplastic disease (except for basal cell carcinoma of the skin, superficial bladder tumors, or properly treated carcinoma in situ of the uterine cervix or melanoma in situ) unless in remission for at least five years and with no recurrence.\n 2. Symptomatic cerebral and/or leptomeningeal metastasis, spinal cord compression or carcinomatous meningitis.\n 3. Neuropathy of any etiology (other than that caused by previous antineoplastic therapy).\n 4. History of cardiac disease, such as myocardial infarction, in the year prior to registration in the clinical trial; symptomatic/uncontrolled angina pectoris; congestive heart failure or uncontrolled cardiac ischemia; any type of uncontrolled arrhythmia, congenital and/or prolonged QT interval or abnormal LVEF, or uncontrolled arterial hypertension (according to the standards of the World Health Organization \\[WHO\\]).\n 5. History of significant psychiatric disease.\n 6. Active infection requiring antibiotic, antifungal or antiviral treatment that, in the opinion of the Investigator, could compromise the patient's capacity to tolerate the therapy.\n 7. Known active liver (hepatitis B or C or cirrhosis) or renal disease.\n 8. Known human immunodeficiency virus (HIV) infection.\n 9. Any other concomitant pathology that could jeopardize the patient's safety or commitment to complete the clinical trial.\n 10. Inability or refusal to comply with the protocol or with the clinical trial procedures.\n5. Pregnancy or lactation."}, 'identificationModule': {'nctId': 'NCT03427268', 'briefTitle': 'Clinical Trial of PM60184 in Advanced Colorectal Cancer After Standard Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'PharmaMar'}, 'officialTitle': 'A Phase II, Open-label, Multicentre Study of PM060184 in Patients With Advanced Colorectal Cancer After Standard Treatment.', 'orgStudyIdInfo': {'id': 'PM60184-B-002-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PM060184', 'description': 'PM060184', 'interventionNames': ['Drug: PM060184']}], 'interventions': [{'name': 'PM060184', 'type': 'DRUG', 'description': 'PM060184: 9.3 mg/m2 PM060184 i.v. as a 30-minute infusion via a central or peripheral venous catheter.Dose can be rounded to the first decimal point.\n\nPM060184 will be administered on Day 1 and Day 8 q3wk. (Three weeks=one treatment cycle).', 'armGroupLabels': ['PM060184']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90089-9181', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'US017', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': 'ON M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'CA001', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'ES001', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'ES009', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'ES002', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PharmaMar', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}