Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
Study NCT ID:
NCT01431794
Status:
TERMINATED
Last Update Posted:
2020-01-22
First Post:
2011-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Gemcitabine + Nab-paclitaxel With LDE-225 (Hedgehog Inhibitor) as Neoadjuvant Therapy for Pancreatic Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C561435', 'term': 'sonidegib'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D000068196', 'term': 'Albumin-Bound Paclitaxel'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'adejesu1@jhmi.edu', 'phone': '443-287-0411', 'title': 'Dr. Ana De Jesus-Acosta', 'organization': 'Johns Hopkins University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'up to 3 years', 'description': 'Only for eligible participants. There were no participants enrolled in Phase I: gem, nab-paclitaxel, and LDE225-400mg, Phase I: gem, nab-paclitaxel, and LDE225-800mg, Phase II Arm A, and Phase II Arm B because the study was terminated early', 'eventGroups': [{'id': 'EG000', 'title': 'Phase I, Gem, Nab-paclitaxel, and LDE225-600mg', 'description': 'Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle with oral LDE225, 600mg.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'deathsNumAffected': 2, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Phase I, Gem, Nab-paclitaxel, and LDE225-400mg', 'description': 'Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle with oral LDE225, 400mg.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Phase I, Gem, Nab-paclitaxel, and LDE225-800mg', 'description': 'Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2o n days 1, 8, and 15 every 28 days cycle with oral LDE225, 800mg.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Phase II, Arm A: Gem, Nab-paclitaxel, and LDE 225', 'description': 'Phase II:\n\nArm A: Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15 in combination with LDE-225 at the recommended phase I dose. Cycles repeated every 28 days.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Phase II, Arm B: Gemcitabine and Nab-paclitaxel', 'description': 'Phase II:\n\nArm B: Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15. Cycles repeated every 28 days.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'WBC decreased', 'notes': 'count of white blood cells', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 68, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemoglobin decreased', 'notes': 'hemoglobin count decreased and anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 60, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ALT increased', 'notes': 'alanine aminotransferase level increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 30, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'sodium decreased', 'notes': 'sodium ion decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Glucose increased', 'notes': 'blood glucose level increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 52, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Alkaline phosphatase increased', 'notes': 'alkaline phosphatase level increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 28, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 23, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'AST increased', 'notes': 'Aspartate aminotransferase level increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 34, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Calcium decreased', 'notes': 'calcium ion in blood decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 20, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphocytes decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 51, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutrophiles decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 32, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Platelets decreased', 'notes': 'platelets count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 23, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 28, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 19, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 23, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 24, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 15, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdomin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 21, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'nausea, vomitting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'abdomina pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fever and tachydysrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'spesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'toxic mega-colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'elevated creatine kinase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0}, {'groupId': 'EG002', 'numAtRisk': 0}, {'groupId': 'EG003', 'numAtRisk': 0}, {'groupId': 'EG004', 'numAtRisk': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase I - Safety and Feasibility of Gemcitabine and Nab-Paclitaxel in Combination With LDE-225 as Neoadjuvant Therapy as Measured by Number of Participants Who Tolerated the Maximal Dose of LDE-225', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I: Gem, Nab-paclitaxel, and LDE225-600mg', 'description': 'Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 600 mg daily.'}, {'id': 'OG001', 'title': 'Phase I: Gem, Nab-paclitaxel, and LDE225-400mg', 'description': 'Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 400 mg daily.'}, {'id': 'OG002', 'title': 'Phase I: Gem, Nab-paclitaxel, and LDE225-800mg', 'description': 'Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 800 mg daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Number of participants who tolerated the maximal dose of LDE-225 in combination with gemcitabine, nab-paclitaxel as neoadjuvant therapy in patients with borderline resectable pancreatic adenocarcinoma (PDA).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure only applies to the Phase I arms. All 13 subjects participated in the Arm/group: Phase I: gem, nab-paclitaxel, and LDE225-600mg. There were no participants enrolled in other two Arm/group as the study was terminated.'}, {'type': 'PRIMARY', 'title': 'Phase II - Resection Rate of Two Preoperative Chemotherapy Regimens in Patients With Borderline Resectable PDA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase II-Arm A:Gem,Nab-paclitaxel,LDE225', 'description': 'Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15 in combination with LDE-225 at the recommended phase 2 dose. Cycles repeated every 28 days.\n\nLDE225-600mg: Phase I: oral LDE225 (Sonidegib), 600mg daily.\n\nPhase II Arm A: LDE225 at the recommended phase 2 dose on Days 1, 8 and 15. Cycles repeated every 28 days.\n\nGemcitabine: Four cycles of Gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days.\n\nnab-paclitaxel: Four cycles of nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days.\n\nLDE225-400mg: Phase I: oral LDE225 (Sonidegib), 400mg daily.\n\nLDE225-800mg: Phase I: oral LDE225 (Sonidegib), 800mg daily.'}, {'id': 'OG001', 'title': 'Phase II-Arm B:Gem,Nab-paclitaxel', 'description': 'Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15. Cycles repeated every 28 days.\n\nGemcitabine: Four cycles of Gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days.\n\nnab-paclitaxel: Four cycles of nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days.'}], 'timeFrame': '5 years', 'description': 'Number of participants with borderline resectable pancreatic adenocarcinoma (PDA) who undergo resection after therapy', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected to assess this outcome measure as the study was terminated before Phase II.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I: Gem, Nab-paclitaxel, and LDE225-600mg', 'description': 'Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 600 mg daily.'}, {'id': 'OG001', 'title': 'Phase I: Gem, Nab-paclitaxel, and LDE225-400mg', 'description': 'Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 400 mg daily.'}, {'id': 'OG002', 'title': 'Phase I: Gem, Nab-paclitaxel, and LDE225-800mg', 'description': 'Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 800 mg daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '60'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '5 years', 'description': 'Number of months alive from cycle 1, Day 1 until 5 years post-intervention or death, whichever comes first.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure only applies to the Phase I arms. All 13 subjects participated in the Arm/group: Phase I: gem, nab-paclitaxel, and LDE225-600mg. There were no participants enrolled in other two Arm/group as the study was terminated.'}, {'type': 'SECONDARY', 'title': 'Overall Tumor Response as Determined by Number of Participants With Complete or Partial Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase I: Gem, Nab-paclitaxel, and LDE225-600mg', 'description': 'Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 600 mg daily.'}, {'id': 'OG001', 'title': 'Phase I: Gem, Nab-paclitaxel, and LDE225-400mg', 'description': 'Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 400 mg daily.'}, {'id': 'OG002', 'title': 'Phase I: Gem, Nab-paclitaxel, and LDE225-800mg', 'description': 'Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 800 mg daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '5 years', 'description': 'Number of participants who experienced complete response (CR) or partial response (PR), as defined by RECIST v1.0; where CR is a disappearance of all target lesions and PR is ≥30% reduction of target lesions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'This measure only applies to the Phase I arms. All 13 subjects participated in the Arm/group: Phase I: gem, nab-paclitaxel, and LDE225-600mg. There were no participants enrolled in other two Arm/group as the study was terminated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase I: Gem, Nab-paclitaxel, and LDE225-600mg', 'description': 'Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 600 mg daily.'}, {'id': 'FG001', 'title': 'Phase I: Gem, Nab-paclitaxel, and LDE225-400mg', 'description': 'Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 400 mg daily.'}, {'id': 'FG002', 'title': 'Phase I: Gem, Nab-paclitaxel, and LDE225-800mg', 'description': 'Four cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 800 mg daily.'}, {'id': 'FG003', 'title': 'Phase II: Arm A - Gem, Nab-paclitaxel, and LDE 225', 'description': 'Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15 in combination with LDE-225 at the recommended phase 2 dose. Cycles repeated every 28 days.'}, {'id': 'FG004', 'title': 'Phase II: Arm B - Gemcitabine and Nab-paclitaxel', 'description': 'Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15. Cycles repeated every 28 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'comment': "not started due to early study's termination", 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': "not started due to early study's termination", 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': "not started due to early study's termination", 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': "not started due to early study's termination", 'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'comment': "not started due to early study's termination", 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': "not started due to early study's termination", 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': "not started due to early study's termination", 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': "not started due to early study's termination", 'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '10 subjects were screen failures. All of 13 subjects were enrolled into the Arm/group: Phase I: gem, nab-paclitaxel, and LDE225-600mg. Other Arm/group did not enroll any subjects due to early termination of the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase I, Gem, Nab-paclitaxel, and LDE225-600mg', 'description': 'Phase I:\n\nFour cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with oral LDE225 600 mg daily'}, {'id': 'BG001', 'title': 'Phase I, Gem, Nab-paclitaxel, and LDE225-400mg', 'description': 'Phase I:\n\nFour cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with oral LDE225 400 mg daily'}, {'id': 'BG002', 'title': 'Phase I, Gem, Nab-paclitaxel, and LDE225-800mg', 'description': 'Phase I:\n\nFour cycles of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with oral LDE225 800 mg daily'}, {'id': 'BG003', 'title': 'Phase II, Arm A: Gem, Nab-paclitaxel, and LDE 225', 'description': 'Phase II:\n\nArm A: Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15 in combination with LDE-225 at the recommended phase 2 dose from Phase I. Cycles repeated every 28 days.'}, {'id': 'BG004', 'title': 'Phase II, Arm B: Gemcitabine and Nab-paclitaxel', 'description': 'Phase II:\n\nArm B: Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15. Cycles repeated every 28 days.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.62', 'spread': '9.32', 'groupId': 'BG000'}, {'value': '61.62', 'spread': '9.32', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Not Hispanic or Latino', 'categories': [{'title': 'White or Caucasian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG005'}]}, {'title': 'Others', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': "All participants were enrolled in Phase 1, gem, nab-paclitaxel, and LDE225-600mg arm only. Other arms did not have any participants due to the study's early termination."}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-08-13', 'size': 1885051, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-01-04T16:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'Study was terminated due to cease in manufacturing of study drug.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-17', 'studyFirstSubmitDate': '2011-07-19', 'resultsFirstSubmitDate': '2019-03-01', 'studyFirstSubmitQcDate': '2011-09-08', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-03', 'studyFirstPostDateStruct': {'date': '2011-09-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase I - Safety and Feasibility of Gemcitabine and Nab-Paclitaxel in Combination With LDE-225 as Neoadjuvant Therapy as Measured by Number of Participants Who Tolerated the Maximal Dose of LDE-225', 'timeFrame': '5 years', 'description': 'Number of participants who tolerated the maximal dose of LDE-225 in combination with gemcitabine, nab-paclitaxel as neoadjuvant therapy in patients with borderline resectable pancreatic adenocarcinoma (PDA).'}, {'measure': 'Phase II - Resection Rate of Two Preoperative Chemotherapy Regimens in Patients With Borderline Resectable PDA', 'timeFrame': '5 years', 'description': 'Number of participants with borderline resectable pancreatic adenocarcinoma (PDA) who undergo resection after therapy'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '5 years', 'description': 'Number of months alive from cycle 1, Day 1 until 5 years post-intervention or death, whichever comes first.'}, {'measure': 'Overall Tumor Response as Determined by Number of Participants With Complete or Partial Response', 'timeFrame': '5 years', 'description': 'Number of participants who experienced complete response (CR) or partial response (PR), as defined by RECIST v1.0; where CR is a disappearance of all target lesions and PR is ≥30% reduction of target lesions.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pancreatic ductal adenocarcinoma (PDA)Neoplasms', 'LDE225', 'nab-paclitaxel', 'abraxane', 'gemcitabine', 'neoadjuvant', 'cytotoxic', 'hedgehog inhibitor', 'stromal cells', 'resectable PDA', 'Pancreatic Diseases', 'Carcinoma', 'Sonidegib'], 'conditions': ['Pancreatic Ductal Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'This is an open-label phase 1/2 study that will combine the chemotherapy agents gemcitabine and nab-paclitaxel with an oral hedgehog inhibitor LDE225 (Sonidegib). The objective is to assess tolerability and the resection rate of patients with borderline resectable pancreatic adenocarcinoma who use this treatment.', 'detailedDescription': 'The investigators propose treating 6-12 patients during the phase 1 portion and 40 patients in the phase 2 stage.\n\nPhase 1 Stage:\n\nFour cycles of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 on days 1, 8 and 15 in combination with escalating doses (400mg, or 600mg, or 800mg) of LDE-225. After completion of neoadjuvant therapy, the subjects will receive combined chemotherapy and radiation. Then subjects who are eligible for resection will go ahead with surgery. Following resection, subjects will complete two additional cycles of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 in combination with LDE-225.\n\nPhase 2 Stage: In the Phase 2 stage the patients will be randomized to receive gemcitabine and nab-paclitaxel with or without the hedgehog inhibitor LDE225:\n\n1. Arm A: Four cycles of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m on days 1, 8 and 15 in combination with LDE-225 at the recommended phase 2 dose.\n2. Arm B: Four cycles of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m on days 1, 8 and 15.\n\nAfter completion of neoadjuvant therapy, the subjects will receive combined chemotherapy and radiation. Then subjects who are eligible for resection will go ahead with surgery. Following resection, subjects will complete two additional cycles of the pre-surgical therapy.\n\nSeveral correlative laboratory studies will be conducted during the course of this study. They were designed around the goals of providing us with a better understanding of how the stroma-tumor interaction and the intra-tumoral drug levels of gemcitabine are affected with the use of LDE-225. Two additional biopsies are required to participate in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the pancreas.\n* Must have borderline resectable pancreatic adenocarcinoma\n* Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension\n* No previous radiotherapy, surgery, chemotherapy or investigational drug therapy.\n* Age \\>18 years\n* Life expectancy of greater than 1 month.\n* ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1\n* Adequate organ and marrow function\n* Asymptomatic for jaundice and ascites. Pain symptoms should be stable.\n* Negative serum pregnancy test\n* Sexually active males should agree to use a barrier form of contraception, even if they have had a vasectomy, during the study and for 6 months after stopping LDE225. Males should not donate sperm during treatment, and for up to six months after last dose. Sexually active females of child bearing potential agree to using highly effective contraception during study and for 20 months after final dose of LDE225.\n* Agree not to donate blood products for 12 months after stopping LDE225.\n* Willing to have two biopsies while on treatment for correlative studies.\n\nExclusion Criteria:\n\n* Patients who have had previous radiotherapy, surgical resection, chemotherapy or investigational drug therapy for pancreatic adenocarcinoma.\n* Patient has known metastatic disease.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to LDE225 or other agents used in the study.\n* Patients taking medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin®)\n* Uncontrolled illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure not controlled with medication, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Pregnant women are excluded\n* Patient has undergone a major surgery, other than diagnostic surgery within four weeks prior to starting treatment on this study.\n* Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of CYP3A4/5 or drugs metabolized by CYP2B6 or CYP2C9 that have narrow therapeutic index, and that cannot be discontinued before starting treatment with LDE225. Medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with LDE225.\n* Patients with neuromuscular disorders.\n* Patients with impaired cardiac function.'}, 'identificationModule': {'nctId': 'NCT01431794', 'briefTitle': 'Gemcitabine + Nab-paclitaxel With LDE-225 (Hedgehog Inhibitor) as Neoadjuvant Therapy for Pancreatic Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins'}, 'officialTitle': 'Phase 1/2 Safety and Feasibility of Gemcitabine and Nab-Paclitaxel in Combination With LDE-225 as Neoadjuvant Therapy in Patients With Borderline Resectable Pancreatic Adenocarcinoma.', 'orgStudyIdInfo': {'id': 'J1130'}, 'secondaryIdInfos': [{'id': 'NA_00047491', 'type': 'OTHER', 'domain': 'JHMIRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase I-Gem,nab-paclitaxel,LDE225-600mg', 'description': 'Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 600 mg daily.', 'interventionNames': ['Drug: LDE225-600mg', 'Drug: Gemcitabine', 'Drug: nab-paclitaxel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase II-Arm A:Gem,nab-paclitaxel,LDE225', 'description': 'Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15 in combination with LDE-225 at the recommended phase 2 dose. Cycles repeated every 28 days.', 'interventionNames': ['Drug: LDE225-600mg', 'Drug: Gemcitabine', 'Drug: nab-paclitaxel', 'Drug: LDE225-400mg', 'Drug: LDE225-800mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phase II-Arm B:Gem,nab-paclitaxel', 'description': 'Four cycles of gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8 and 15. Cycles repeated every 28 days.', 'interventionNames': ['Drug: Gemcitabine', 'Drug: nab-paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I-Gem,nab-paclitaxel,LDE225-400mg', 'description': 'Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 400 mg daily.', 'interventionNames': ['Drug: Gemcitabine', 'Drug: nab-paclitaxel', 'Drug: LDE225-400mg']}, {'type': 'EXPERIMENTAL', 'label': 'Phase I-Gem,nab-paclitaxel,LDE225-800mg', 'description': 'Four cycles of Gemcitabine (gem) 1000 mg/m2 and nab-Paclitaxel 125 mg/ m2 on days 1, 8, and 15 every 28 days cycle in combination with escalating doses of oral LDE225 (Sonidegib), 800 mg daily.', 'interventionNames': ['Drug: Gemcitabine', 'Drug: nab-paclitaxel', 'Drug: LDE225-800mg']}], 'interventions': [{'name': 'LDE225-600mg', 'type': 'DRUG', 'otherNames': ['Sonidegib'], 'description': 'Phase I: oral LDE225 (Sonidegib), 600mg daily.\n\nPhase II Arm A: LDE225 at the recommended phase 2 dose on Days 1, 8 and 15. Cycles repeated every 28 days.', 'armGroupLabels': ['Phase I-Gem,nab-paclitaxel,LDE225-600mg', 'Phase II-Arm A:Gem,nab-paclitaxel,LDE225']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'otherNames': ['gem'], 'description': 'Four cycles of Gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days.', 'armGroupLabels': ['Phase I-Gem,nab-paclitaxel,LDE225-400mg', 'Phase I-Gem,nab-paclitaxel,LDE225-600mg', 'Phase I-Gem,nab-paclitaxel,LDE225-800mg', 'Phase II-Arm A:Gem,nab-paclitaxel,LDE225', 'Phase II-Arm B:Gem,nab-paclitaxel']}, {'name': 'nab-paclitaxel', 'type': 'DRUG', 'otherNames': ['abraxane'], 'description': 'Four cycles of nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days.', 'armGroupLabels': ['Phase I-Gem,nab-paclitaxel,LDE225-400mg', 'Phase I-Gem,nab-paclitaxel,LDE225-600mg', 'Phase I-Gem,nab-paclitaxel,LDE225-800mg', 'Phase II-Arm A:Gem,nab-paclitaxel,LDE225', 'Phase II-Arm B:Gem,nab-paclitaxel']}, {'name': 'LDE225-400mg', 'type': 'DRUG', 'otherNames': ['Sonidegib'], 'description': 'Phase I: oral LDE225 (Sonidegib), 400mg daily.', 'armGroupLabels': ['Phase I-Gem,nab-paclitaxel,LDE225-400mg', 'Phase II-Arm A:Gem,nab-paclitaxel,LDE225']}, {'name': 'LDE225-800mg', 'type': 'DRUG', 'otherNames': ['Sonidegib'], 'description': 'Phase I: oral LDE225 (Sonidegib), 800mg daily.', 'armGroupLabels': ['Phase I-Gem,nab-paclitaxel,LDE225-800mg', 'Phase II-Arm A:Gem,nab-paclitaxel,LDE225']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Ana De Jesus-Acosta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sidney Kimmel Comprehensive Cancer Center JHMI'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, {'name': 'The Skip Viragh Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}