Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-02-20 @ 8:07 PM
Study NCT ID:
NCT02030067
Status:
COMPLETED
Last Update Posted:
2023-12-06
First Post:
2013-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000589325', 'term': 'fluorocyclopentenylcytosine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pfranks@processapharmaceuticals.com', 'phone': '443-631-6614', 'title': 'Director Drug Development and Regulatory Affairs', 'organization': 'Processa Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'up to 224 days (8 cycles of treatment)', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1 (Dose Escalation) 30 mg 3x/Week', 'description': 'RX-3117 30 mg administered 3 times/week', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Phase 1 (Dose Escalation) 60 mg 3x/Week', 'description': 'RX-3117 60 mg administered 3 times/week', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Phase 1 (Dose Escalation) 100 mg 3x/Week', 'description': 'RX-3117 100 mg administered 3 times/week', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Phase 1 (Dose Escalation) 150 mg 3x/Week', 'description': 'RX-3117 150 mg administered 3 times/week', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Phase 1 (Dose Escalation) 200 mg 3x/Week', 'description': 'RX-3117 200 mg administered 3 times/week', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Phase 1 (Dose Escalation) 500 mg 3x/Week', 'description': 'RX-3117 500 mg administered 3 times/week', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Phase 1 (Dose Escalation) 1000 mg 3x/Week', 'description': 'RX-3117 1000 mg administered 3 times/week', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'Phase 1 (Dose Escalation) 1500 mg 3x/Week', 'description': 'RX-3117 1500 mg administered 3 times/week', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Phase 1 (Dose Escalation) 2000 mg 3x/Week', 'description': 'RX-3117 2000 mg administered 3 times/week', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'Phase 1 (Dose Escalation) 500 mg 5x/Week', 'description': 'RX-3117 500 mg administered 5 times/week', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG010', 'title': 'Phase 1 (Dose Escalation) 700 mg 5x/Week', 'description': 'RX-3117 700 mg administered 5 times/week', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG011', 'title': 'Phase 1 (Dose Escalation) 500 mg 7x/Week', 'description': 'RX-3117 500 mg administered 7 times/week', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG012', 'title': 'Phase 2 700 mg', 'description': 'RX-3117 700 mg administered 5 times/week', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 78, 'seriousNumAtRisk': 80, 'deathsNumAffected': 8, 'seriousNumAffected': 29}], 'otherEvents': [{'term': 'nausea', 'stats': 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0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 80, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 80, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 80, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 80, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 80, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 6}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 80, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 80, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 80, 'numAffected': 15}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 4}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 80, 'numAffected': 38}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 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'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 80, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 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'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 80, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'RX-3117 30 mg, 3 Times/Week', 'description': 'Subjects will receive 30 mg RX-3117, 3 times/week'}, {'id': 'OG001', 'title': 'RX-3117 60 mg, 3 Times/Week', 'description': 'Subjects will receive 60 mg RX-3117 3 times/week'}, {'id': 'OG002', 'title': 'RX-3117 100 mg, 3 Times/Week', 'description': 'Subjects will receive 100 mg RX-3117 3 times/week'}, {'id': 'OG003', 'title': 'RX-3117 150 mg, 3 Times/Week', 'description': 'Subjects will receive 150 mg RX-3117, 3 times/week'}, {'id': 'OG004', 'title': 'RX-3117 200 mg, 3 Times/Week', 'description': 'Subjects will receive 200 mg of RX-3117, 3 times/week'}, {'id': 'OG005', 'title': 'RX-3117 500 mg, 3 Times/Week', 'description': 'Subjects will receive 500 mg RX-3117, 3 times/week'}, {'id': 'OG006', 'title': 'RX-3117 1000 mg, 3 Times/Week', 'description': 'Subjects received 1000 mg RX-3117, 3 times/week'}, {'id': 'OG007', 'title': 'RX 3117 1500 mg, 3 Times/Week', 'description': 'Subjects received 1500 mg RX-3117, 3 times/week'}, {'id': 'OG008', 'title': 'RX-3117 2000 mg, 3 Times/Week', 'description': 'Subjects received 2000 mg RX-3117, 3 times/week'}, {'id': 'OG009', 'title': 'RX-3117 500 mg, 5 Times/Week', 'description': 'Subjects receivved 500 mg RX-3117, 5 times/week'}, {'id': 'OG010', 'title': 'RX-3117 700 mg, 5 Times/Week', 'description': 'Subjects received 700 mg RX-3117, 5 times/week'}, {'id': 'OG011', 'title': 'RX-3117 500 mg, 7 Times/Week', 'description': 'Subjects received 500 mg RX-3117, 7 times/week'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Number of subjects participating in Phase 1 that experienced a DLT during the first cycle of treatment (28 days)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'RX-3117 30 mg, 3 Times/Week', 'description': 'Subjects will receive 30 mg RX-3117, 3 times/week'}, {'id': 'OG001', 'title': 'RX-3117 60 mg, 3 Times/Week', 'description': 'Subjects will receive 60 mg RX-3117 3 times/week'}, {'id': 'OG002', 'title': 'RX-3117 100 mg, 3 Times/Week', 'description': 'Subjects will receive 100 mg RX-3117 3 times/week'}, {'id': 'OG003', 'title': 'RX-3117 150 mg, 3 Times/Week', 'description': 'Subjects will receive 150 mg RX-3117, 3 times/week'}, {'id': 'OG004', 'title': 'RX-3117 200 mg, 3 Times/Week', 'description': 'Subjects will receive 200 mg of RX-3117, 3 times/week'}, {'id': 'OG005', 'title': 'RX-3117 500 mg, 3 Times/Week', 'description': 'Subjects will receive 500 mg RX-3117, 3 times/week'}, {'id': 'OG006', 'title': 'RX-3117 1000 mg, 3 Times/Week', 'description': 'Subjects received 1000 mg RX-3117, 3 times/week'}, {'id': 'OG007', 'title': 'RX 3117 1500 mg, 3 Times/Week', 'description': 'Subjects received 1500 mg RX-3117, 3 times/week'}, {'id': 'OG008', 'title': 'RX-3117 2000 mg, 3 Times/Week', 'description': 'Subjects received 2000 mg RX-3117, 3 times/week'}, {'id': 'OG009', 'title': 'RX-3117 500 mg, 5 Times/Week', 'description': 'Subjects receivved 500 mg RX-3117, 5 times/week'}, {'id': 'OG010', 'title': 'RX-3117 700 mg, 5 Times/Week', 'description': 'Subjects received 700 mg RX-3117, 5 times/week'}, {'id': 'OG011', 'title': 'RX-3117 500 mg, 7 Times/Week', 'description': 'Subjects received 500 mg RX-3117, 7 times/week'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}, {'value': '5', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study completion, up to 224 days (8 cycles of treatment)', 'description': 'Number of subjects participating in Phase 1 that experience any SAEs', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes those subjects participating in the dose escalation phase of the study (Phase 1)'}, {'type': 'PRIMARY', 'title': 'Overall Safety Profile Characterized by the Number of Subjects That Discontinue Study Treatment - Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'RX-3117 30 mg, 3 Times/Week', 'description': 'Subjects will receive 30 mg RX-3117, 3 times/week'}, {'id': 'OG001', 'title': 'RX-3117 60 mg, 3 Times/Week', 'description': 'Subjects will receive 60 mg RX-3117 3 times/week'}, {'id': 'OG002', 'title': 'RX-3117 100 mg, 3 Times/Week', 'description': 'Subjects will receive 100 mg RX-3117 3 times/week'}, {'id': 'OG003', 'title': 'RX-3117 150 mg, 3 Times/Week', 'description': 'Subjects will receive 150 mg RX-3117, 3 times/week'}, {'id': 'OG004', 'title': 'RX-3117 200 mg, 3 Times/Week', 'description': 'Subjects will receive 200 mg of RX-3117, 3 times/week'}, {'id': 'OG005', 'title': 'RX-3117 500 mg, 3 Times/Week', 'description': 'Subjects will receive 500 mg RX-3117, 3 times/week'}, {'id': 'OG006', 'title': 'RX-3117 1000 mg, 3 Times/Week', 'description': 'Subjects received 1000 mg RX-3117, 3 times/week'}, {'id': 'OG007', 'title': 'RX 3117 1500 mg, 3 Times/Week', 'description': 'Subjects received 1500 mg RX-3117, 3 times/week'}, {'id': 'OG008', 'title': 'RX-3117 2000 mg, 3 Times/Week', 'description': 'Subjects received 2000 mg RX-3117, 3 times/week'}, {'id': 'OG009', 'title': 'RX-3117 500 mg, 5 Times/Week', 'description': 'Subjects receivved 500 mg RX-3117, 5 times/week'}, {'id': 'OG010', 'title': 'RX-3117 700 mg, 5 Times/Week', 'description': 'Subjects received 700 mg RX-3117, 5 times/week'}, {'id': 'OG011', 'title': 'RX-3117 500 mg, 7 Times/Week', 'description': 'Subjects received 500 mg RX-3117, 7 times/week'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study completion, up to 224 days (8 cycles of treatment)', 'description': 'Number of subjects participating in Phase 1 of study that discontinued study treatment due to a treatment emergent adverse event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects in the dose escalation phase of the study (Phase 1)'}, {'type': 'PRIMARY', 'title': 'Overall Safety Profile Characterized by Number of Subjects Experiencing a Treatment Emergent Adverse Event- Phase 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '11', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'RX-3117 30 mg, 3 Times/Week', 'description': 'Subjects will receive 30 mg RX-3117, 3 times/week'}, {'id': 'OG001', 'title': 'RX-3117 60 mg, 3 Times/Week', 'description': 'Subjects will receive 60 mg RX-3117 3 times/week'}, {'id': 'OG002', 'title': 'RX-3117 100 mg, 3 Times/Week', 'description': 'Subjects will receive 100 mg RX-3117 3 times/week'}, {'id': 'OG003', 'title': 'RX-3117 150 mg, 3 Times/Week', 'description': 'Subjects will receive 150 mg RX-3117, 3 times/week'}, {'id': 'OG004', 'title': 'RX-3117 200 mg, 3 Times/Week', 'description': 'Subjects will receive 200 mg of RX-3117, 3 times/week'}, {'id': 'OG005', 'title': 'RX-3117 500 mg, 3 Times/Week', 'description': 'Subjects will receive 500 mg RX-3117, 3 times/week'}, {'id': 'OG006', 'title': 'RX-3117 1000 mg, 3 Times/Week', 'description': 'Subjects received 1000 mg RX-3117, 3 times/week'}, {'id': 'OG007', 'title': 'RX 3117 1500 mg, 3 Times/Week', 'description': 'Subjects received 1500 mg RX-3117, 3 times/week'}, {'id': 'OG008', 'title': 'RX-3117 2000 mg, 3 Times/Week', 'description': 'Subjects received 2000 mg RX-3117, 3 times/week'}, {'id': 'OG009', 'title': 'RX-3117 500 mg, 5 Times/Week', 'description': 'Subjects receivved 500 mg RX-3117, 5 times/week'}, {'id': 'OG010', 'title': 'RX-3117 700 mg, 5 Times/Week', 'description': 'Subjects received 700 mg RX-3117, 5 times/week'}, {'id': 'OG011', 'title': 'RX-3117 500 mg, 7 Times/Week', 'description': 'Subjects received 500 mg RX-3117, 7 times/week'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '9', 'groupId': 'OG010'}, {'value': '3', 'groupId': 'OG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through study completion, up to 224 days (8 cycles of treatment)', 'description': 'Number of subjects that experience any treatment-related adverse event.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Population includes subjects participating in the dose escalation phase of the study (Phase 1)'}, {'type': 'PRIMARY', 'title': 'Progression Free Survival (Phase 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RX-3117 700 mg 5 Times/Week (Phase 2 Portion of Study)', 'description': 'Subjects received MTD of 700 mg RX-3117, 5 times/week'}], 'classes': [{'title': 'Pancreatic cancer patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '3.14', 'upperLimit': '8.00'}]}]}, {'title': 'Bladder cancer patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '7.14', 'upperLimit': '13.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 months', 'description': 'Progression Free Survival in Phase 2 of the study for pancreatic and bladder cancer subjects.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients participating in Phase 2 of the study, which included 41 pancreatic cancer and 31 bladder cancer patients'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration Time Curve (AUC) (Phase 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RX-3117', 'description': 'All subjects will receive RX-3117.\n\nRX-3117'}], 'timeFrame': 'Pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours after oral administration in Cycle 1 Days 1 and 15', 'reportingStatus': 'POSTED', 'populationDescription': 'No pharmacokinetic analysis was conducted'}, {'type': 'SECONDARY', 'title': 'Best Overall Response Rate (Phase 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RX-3117 700 mg 5 Times/Week (Phase 2 Portion of Study)', 'description': 'Subjects received MTD of 700 mg RX-3117, 5 times/week'}], 'classes': [{'title': 'pancreatic subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000', 'lowerLimit': '14.2', 'upperLimit': '42.9'}]}]}, {'title': 'bladder subjects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000', 'lowerLimit': '27.3', 'upperLimit': '64.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and at 4, 8, 12, 16 and 32 weeks', 'description': 'Best Overall Response Rate (includes Complete Response, Partial Response, and Stable Disease)', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable for Tumor Response Analysis Set (includes Bladder and Pancreatic patients in Phase 2)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Biomarker Concentrations in Blood (Phase 1 and Phase 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}]}], 'groups': [{'id': 'OG000', 'title': 'RX-3117 30 mg, 3 Times/Week', 'description': 'Subjects will receive 30 mg RX-3117, 3 times/week'}, {'id': 'OG001', 'title': 'RX-3117 60 mg, 3 Times/Week', 'description': 'Subjects will receive 60 mg RX-3117 3 times/week'}, {'id': 'OG002', 'title': 'RX-3117 100 mg, 3 Times/Week', 'description': 'Subjects will receive 100 mg RX-3117 3 times/week'}, {'id': 'OG003', 'title': 'RX-3117 150 mg, 3 Times/Week', 'description': 'Subjects will receive 150 mg RX-3117, 3 times/week'}, {'id': 'OG004', 'title': 'RX-3117 200 mg, 3 Times/Week', 'description': 'Subjects will receive 200 mg of RX-3117, 3 times/week'}, {'id': 'OG005', 'title': 'RX-3117 500 mg, 3 Times/Week', 'description': 'Subjects will receive 500 mg RX-3117, 3 times/week'}, {'id': 'OG006', 'title': 'RX-3117 1000 mg, 3 Times/Week', 'description': 'Subjects received 1000 mg RX-3117, 3 times/week'}, {'id': 'OG007', 'title': 'RX 3117 1500 mg, 3 Times/Week', 'description': 'Subjects received 1500 mg RX-3117, 3 times/week'}, {'id': 'OG008', 'title': 'RX-3117 2000 mg, 3 Times/Week', 'description': 'Subjects received 2000 mg RX-3117, 3 times/week'}, {'id': 'OG009', 'title': 'RX-3117 500 mg, 5 Times/Week', 'description': 'Subjects receivved 500 mg RX-3117, 5 times/week'}, {'id': 'OG010', 'title': 'RX-3117 700 mg, 5 Times/Week', 'description': 'Subjects received 700 mg RX-3117, 5 times/week'}, {'id': 'OG011', 'title': 'RX-3117 500 mg, 7 Times/Week', 'description': 'Subjects received 500 mg RX-3117, 7 times/week'}, {'id': 'OG012', 'title': 'RX-3117 700 mg 5 Times/Week (Phase 2 Portion of Study)', 'description': 'Subjects received MTD of 700 mg RX-3117, 5 times/week'}], 'timeFrame': 'Baseline and 4, 8, 12, 16 and 32 weeks', 'description': 'Analysis of biomarker data not conducted. Biomarker samples were not analyzed due to previous sponsor terminating clinical program.', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of biomarker data not conducted. Biomarker samples were not analyzed due to previous sponsor terminating clinical program.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RX-3117 30 mg, 3 Times/Week', 'description': 'Subjects will receive 30 mg RX-3117, 3 times/week'}, {'id': 'FG001', 'title': 'RX-3117 60 mg, 3 Times/Week', 'description': 'Subjects will receive 60 mg RX-3117 3 times/week'}, {'id': 'FG002', 'title': 'RX-3117 100 mg, 3 Times/Week', 'description': 'Subjects will receive 100 mg RX-3117 3 times/week'}, {'id': 'FG003', 'title': 'RX-3117 150 mg, 3 Times/Week', 'description': 'Subjects will receive 150 mg RX-3117, 3 times/week'}, {'id': 'FG004', 'title': 'RX-3117 200 mg, 3 Times/Week', 'description': 'Subjects will receive 200 mg of RX-3117, 3 times/week'}, {'id': 'FG005', 'title': 'RX-3117 500 mg, 3 Times/Week', 'description': 'Subjects will receive 500 mg RX-3117, 3 times/week'}, {'id': 'FG006', 'title': 'RX-3117 1000 mg, 3 Times/Week', 'description': 'Subjects received 1000 mg RX-3117, 3 times/week'}, {'id': 'FG007', 'title': 'RX 3117 1500 mg, 3 Times/Week', 'description': 'Subjects received 1500 mg RX-3117, 3 times/week'}, {'id': 'FG008', 'title': 'RX-3117 2000 mg, 3 Times/Week', 'description': 'Subjects received 2000 mg RX-3117, 3 times/week'}, {'id': 'FG009', 'title': 'RX-3117 500 mg, 5 Times/Week', 'description': 'Subjects receivved 500 mg RX-3117, 5 times/week'}, {'id': 'FG010', 'title': 'RX-3117 700 mg, 5 Times/Week', 'description': 'Subjects received 700 mg RX-3117, 5 times/week'}, {'id': 'FG011', 'title': 'RX-3117 500 mg, 7 Times/Week', 'description': 'Subjects received 500 mg RX-3117, 7 times/week'}, {'id': 'FG012', 'title': 'RX-3117 700 mg 5 Times/Week (Phase 2 Portion of Study)', 'description': 'Subjects received MTD of 700 mg RX-3117, 5 times/week'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '11'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'only 1 patient in phase 1 completed; 0 patients in phase 2 completed', 'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '11'}, {'groupId': 'FG011', 'numSubjects': '3'}, {'groupId': 'FG012', 'numSubjects': '80'}]}], 'dropWithdraws': [{'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '3'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '7'}, {'groupId': 'FG011', 'numSubjects': '2'}, {'groupId': 'FG012', 'numSubjects': '59'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '3'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '3'}]}, {'type': 'other reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '4'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}, {'groupId': 'FG012', 'numSubjects': '8'}]}]}], 'preAssignmentDetails': '3 patients enrolled in the Phase 2 portion of the study discontinued prior to dosing. Therefore 124 patients started the study rather than 127 patients as listed in the protocol section.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '11', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '80', 'groupId': 'BG012'}, {'value': '124', 'groupId': 'BG013'}]}], 'groups': [{'id': 'BG000', 'title': 'RX-3117 30 mg 3 Times/Week', 'description': 'Patient received 30 mg RX-3117 3 times/week'}, {'id': 'BG001', 'title': 'RX-3117 60 mg 3 Times/Week', 'description': 'Patient received 60 mg RX-3117 3 times/week'}, {'id': 'BG002', 'title': 'RX-3117 100 mg 3 Times/Week', 'description': 'Patients received 100 mg RX-3117 3 times/week'}, {'id': 'BG003', 'title': 'RX-3117 150 mg 3 Times/Week', 'description': 'Patients received 150 mg RX-3117 3 times/week'}, {'id': 'BG004', 'title': 'RX-3117 200 mg 3 Times/Week', 'description': 'Patients received 200 mg RX-3117 3 times/week'}, {'id': 'BG005', 'title': 'RX-3117 500 mg 3 Times/Week', 'description': 'Patients received 500 mg RX-3117 3 times/week'}, {'id': 'BG006', 'title': 'RX-3117 1000 mg 3 Times/Week', 'description': 'Patients received 1000 mg RX-3117 3 times/week'}, {'id': 'BG007', 'title': 'RX-3117 1500 mg 3 Times/Week', 'description': 'Patients received 1500 mg RX-3117 3 times/week'}, {'id': 'BG008', 'title': 'RX-3117 2000 mg 3 Times/Week', 'description': 'Patients received 2000 mg RX-3117 3 times/week'}, {'id': 'BG009', 'title': 'RX-3117 500 mg 5 Times/Week', 'description': 'Patients received 500 mg RX-3117 5 times/week'}, {'id': 'BG010', 'title': 'RX-3117 700 mg 5 Times/Week', 'description': 'Patients received 700 mg RX-3117 5 times/week'}, {'id': 'BG011', 'title': 'RX-3117 500 mg 7 Times/Week', 'description': 'Patients received RX-3117 500 mg 7 Times/Week'}, {'id': 'BG012', 'title': 'RX-3117 700 mg 5 Times/Week (Phase 2)', 'description': 'Patients received 700 mg RX-3117 5 times/week'}, {'id': 'BG013', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.0', 'spread': '0', 'groupId': 'BG000'}, {'value': '66.0', 'spread': '0', 'groupId': 'BG001'}, {'value': '65.3', 'spread': '5.86', 'groupId': 'BG002'}, {'value': '67.0', 'spread': '4.58', 'groupId': 'BG003'}, {'value': '68.0', 'spread': '6.24', 'groupId': 'BG004'}, {'value': '53.7', 'spread': '7.57', 'groupId': 'BG005'}, {'value': '54.3', 'spread': '4.16', 'groupId': 'BG006'}, {'value': '63.3', 'spread': '16.50', 'groupId': 'BG007'}, {'value': '61.0', 'spread': '13.30', 'groupId': 'BG008'}, {'value': '62.0', 'spread': '13.08', 'groupId': 'BG009'}, {'value': '58.0', 'spread': '10.87', 'groupId': 'BG010'}, {'value': '67.0', 'spread': '6.56', 'groupId': 'BG011'}, {'value': '67.6', 'spread': '9.11', 'groupId': 'BG012'}, {'value': '65.37', 'spread': '9.84', 'groupId': 'BG013'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '8', 'groupId': 'BG010'}, {'value': '3', 'groupId': 'BG011'}, {'value': '34', 'groupId': 'BG012'}, {'value': '63', 'groupId': 'BG013'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '3', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '46', 'groupId': 'BG012'}, {'value': '61', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '1', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '14', 'groupId': 'BG012'}, {'value': '31', 'groupId': 'BG013'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '3', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '63', 'groupId': 'BG012'}, {'value': '90', 'groupId': 'BG013'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '3', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '3', 'groupId': 'BG012'}, {'value': '4', 'groupId': 'BG013'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '8', 'groupId': 'BG012'}, {'value': '10', 'groupId': 'BG013'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '5', 'groupId': 'BG008'}, {'value': '3', 'groupId': 'BG009'}, {'value': '9', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}, {'value': '64', 'groupId': 'BG012'}, {'value': '99', 'groupId': 'BG013'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '1', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '2', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}, {'value': '5', 'groupId': 'BG012'}, {'value': '11', 'groupId': 'BG013'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-02-19', 'size': 1135456, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-12T10:07', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-14', 'studyFirstSubmitDate': '2013-12-24', 'resultsFirstSubmitDate': '2023-04-12', 'studyFirstSubmitQcDate': '2014-01-06', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-14', 'studyFirstPostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Biomarker Concentrations in Blood (Phase 1 and Phase 2)', 'timeFrame': 'Baseline and 4, 8, 12, 16 and 32 weeks', 'description': 'Analysis of biomarker data not conducted. Biomarker samples were not analyzed due to previous sponsor terminating clinical program.'}], 'primaryOutcomes': [{'measure': 'Overall Safety Profile Characterized by # of Subjects With Dose-limiting Toxicities (DLTs) in Phase 1', 'timeFrame': '28 days', 'description': 'Number of subjects participating in Phase 1 that experienced a DLT during the first cycle of treatment (28 days)'}, {'measure': 'Overall Safety Profile Characterized by Number of Subjects Experiencing Serious Adverse Events in Phase 1', 'timeFrame': 'through study completion, up to 224 days (8 cycles of treatment)', 'description': 'Number of subjects participating in Phase 1 that experience any SAEs'}, {'measure': 'Overall Safety Profile Characterized by the Number of Subjects That Discontinue Study Treatment - Phase 1', 'timeFrame': 'through study completion, up to 224 days (8 cycles of treatment)', 'description': 'Number of subjects participating in Phase 1 of study that discontinued study treatment due to a treatment emergent adverse event.'}, {'measure': 'Overall Safety Profile Characterized by Number of Subjects Experiencing a Treatment Emergent Adverse Event- Phase 1', 'timeFrame': 'through study completion, up to 224 days (8 cycles of treatment)', 'description': 'Number of subjects that experience any treatment-related adverse event.'}, {'measure': 'Progression Free Survival (Phase 2)', 'timeFrame': '4 months', 'description': 'Progression Free Survival in Phase 2 of the study for pancreatic and bladder cancer subjects.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Plasma Concentration Time Curve (AUC) (Phase 1)', 'timeFrame': 'Pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 24 and 48 hours after oral administration in Cycle 1 Days 1 and 15'}, {'measure': 'Best Overall Response Rate (Phase 2)', 'timeFrame': 'Baseline and at 4, 8, 12, 16 and 32 weeks', 'description': 'Best Overall Response Rate (includes Complete Response, Partial Response, and Stable Disease)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['oncology', 'tumor', 'metastatic', 'bladder'], 'conditions': ['Solid Tumor', 'Metastatic Bladder Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the maximum tolerated dose of RX-3117 in subjects with advanced or metastatic solid tumors (Phase 1). The purpose of the Phase 2 portion is to estimate anti-tumor activity in subjects with advanced malignancies (relapsed or refractory pancreatic or advanced bladder cancer).', 'detailedDescription': 'This is a dose-finding, open-label, single agent study of RX-3117. Once the maximum tolerated dose is identified additional subjects will be treated in a dose expansion followed by a 2-stage Phase 2 study. Subjects will be treated for up to 8 cycles of therapy. A cycle will be 4 weeks. RX-3117 dosing will be 3 times each week for 3 weeks follow by 1 week off treatment. All subjects will be followed for at least 30 days after the last dose of RX-3117.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females who are 18 years or older\n* Able to swallow capsules\n* Histological or cytological evidence of confirmed metastatic pancreatic or advanced bladder cancer\n* Able to discontinue all anticancer therapies 2 weeks prior to study start\n* Measurable or evaluable disease using Response Evaluation Criteria in Solid Tumors\n* Life expectancy of at least 3 months\n* ECOG performance status of 0 or 1\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Primary brain tumors or clinical evidence of active brain metastasis\n* Systemic corticosteroid use within 7 days before planned start of study therapy\n* Active infection requiring parenteral or oral antibiotics within 2 weeks before planned start of study therapy\n* Uncontrolled diabetes as assessed by the investigator\n* Prior or current history of hepatitis B, hepatitis C or human immunodeficiency virus\n* History of bone marrow of solid organ transplantation\n* History of congestive heart failure, arrhythmias, acute coronary syndrome or torsades de pointes\n* Any other medical, psychiatric, or social condition, which in the opinion of the investigator, would preclude participation in the study, pose an undue medical hazard, interfere with the conduct of the study, or interfere with interpretation of the study results\n* Known hypersensitivity to gemcitabine, azacytidine or cytosine arabinoside\n* Pregnant, planning a pregnancy or breast feeding during the study\n* Concurrent participation in another therapeutic clinical trial'}, 'identificationModule': {'nctId': 'NCT02030067', 'briefTitle': 'Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Processa Pharmaceuticals'}, 'officialTitle': 'A Phase 1, Open-Label, Dose-Ranging, Safety and Pharmacokinetic Study to Determine the Maximum Tolerated Dose of RX-3117 Administered Orally as a Single-Agent to Subjects With Advanced Malignancies', 'orgStudyIdInfo': {'id': 'RX-3117-P1-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RX-3117', 'description': 'All subjects will receive RX-3117.', 'interventionNames': ['Drug: RX-3117']}], 'interventions': [{'name': 'RX-3117', 'type': 'DRUG', 'armGroupLabels': ['RX-3117']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Rexahn Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Rexahn Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'Rexahn Site', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Rexahn Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Rexahn Site', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '60077', 'city': 'Skokie', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rexahn Site', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Rexahn Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89119', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Rexahn Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Rexahn Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Rexahn Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Rexahn Site', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Rexahn Site', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}], 'overallOfficials': [{'name': 'Ely Benaim, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Rexahn Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Processa Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}