Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-30 @ 2:20 AM
Study NCT ID:
NCT04604132
Status:
TERMINATED
Last Update Posted:
2024-04-04
First Post:
2020-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D000168', 'term': 'Acrocephalosyndactylia'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D003398', 'term': 'Craniosynostoses'}, {'id': 'D013580', 'term': 'Synostosis'}, {'id': 'D004413', 'term': 'Dysostoses'}, {'id': 'D001848', 'term': 'Bone Diseases, Developmental'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013576', 'term': 'Syndactyly'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D017880', 'term': 'Limb Deformities, Congenital'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000621805', 'term': 'derazantinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'manuel.haeckl@basilea.com', 'phone': '+41 76 302 53 10', 'title': 'Manuel Häckl, MD', 'organization': 'Basilea Pharmaceutica International Ltd, Allschwil'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months", 'description': 'Treatment emergent adverse events (TEAEs) were defined as AEs that started or worsened in severity on or after the first dose of study treatment and until safety follow-up visit (inclusive).', 'eventGroups': [{'id': 'EG000', 'title': 'Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily', 'description': 'Patients with FGFR2 fusions or amplifications were treated with 300 mg Derazantinib monotherapy once daily', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 12, 'seriousNumAtRisk': 13, 'deathsNumAffected': 10, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily', 'description': 'Patients with FGFR1-3 mutations were treated with 300 mg Derazantinib monotherapy once daily', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 6, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily', 'description': 'Patients with FGFR fusions, amplifications or mutations were treated with 200 mg Derazantinib monotherapy twice daily', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 13, 'seriousNumAtRisk': 13, 'deathsNumAffected': 10, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'Substudy 2: Derazantinib 200 mg Once Daily +Paclitaxel+ Ramucirumab', 'description': 'Patients with FGFR fusions, amplifications or mutations were treated with 200 mg Derazantinib once daily in combination with Paclitaxel and Ramucirumab\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 4, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab', 'description': 'Patients with FGFR fusions, amplifications or mutations were treated with 300 mg Derazantinib once daily in combination with Paclitaxel and Ramucirumab\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood albumin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood phosphorus increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Blood potassium increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 14, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Platelet count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Protein total decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 15, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 1, 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hepatic cytolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 13, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate (ORR) in Substudy 1 (in Cohorts 1.1 and 1.2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily', 'description': 'Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.'}, {'id': 'OG001', 'title': 'Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily', 'description': 'Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '20.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '31.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose and up to 18 months', 'description': 'ORR was defined by the percentage of patients with confirmed complete response (CR, which means disappearance of all target lesions) or partial response (PR, which means \\>=30% decrease in the sum of the longest diameter of target lesions) by blinded independent central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST 1.1). Overall Response (OR) = CR + PR.\n\nThe patients in Cohort 1.1 had FGFR2 fusions or amplification gastric adenocarcinoma (GAC) and FGFR1-3 mutations GAC in Cohort 1.2.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: all patients who received at least one dose of derazantinib and had at least one post-baseline imaging assessment in accordance with RECIST 1.1 or documented clinical progression or died from any cause on or after the first dose of study treatment and until safety follow-up visit (inclusive).'}, {'type': 'PRIMARY', 'title': 'Progression-free Survival at 4 Months (PFS4) in Substudy 1 in Cohort 1.3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily', 'description': 'Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '31.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose and up to 4 months', 'description': 'PFS4 was defined by the percentage of patients alive and free of disease progression (defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions) by BICR per RECIST. 1.1. Patients in this Cohort had FGFR fusions, amplifications or mutations GAC', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all patients who received at least one dose of derazantinib and had at least one post-baseline imaging assessment in accordance with RECIST 1.1 or documented clinical progression or died from any cause on or after the first dose of study treatment and until safety follow-up visit (inclusive).'}, {'type': 'PRIMARY', 'title': 'Recommended Phase 2 Dose (RP2D) in Substudy 2 (Derazantinib-paclitaxel-ramucirumab in Combination)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Substudy 2 Combined: Derazantinib +Paclitaxel+ Ramucirumab', 'description': 'Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of either 200 mg or 300 mg once daily in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.'}], 'classes': [{'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose and up to 18 months', 'description': 'RP2D was determined from safety and tolerability according to the aggregate of dose-limiting toxicity criteria and adverse event (AE) data, and considering further pharmacokinetic and efficacy data of the derazantinib-paclitaxel-ramucirumab combination in patients with FGFR fusions, amplifications or mutations GAC.', 'unitOfMeasure': 'mg', 'reportingStatus': 'POSTED', 'populationDescription': 'The Maximum Tolerated Dose (MTD)-determining population comprised all patients enrolled in Substudy 2 who meet the minimum criteria during the first 28-day treatment cycle (Cycle 1):\n\n* received at least one dose of derazantinib-paclitaxel-ramucirumab in combination and has experienced a DLT\n* or\n* received ≥ 80% of the derazantinib-paclitaxel-ramucirumab dose, respectively, in Cycle 1 and, had been observed for ≥ 28 days following the first dose, and had been evaluated for safety.'}, {'type': 'SECONDARY', 'title': 'ORR in Substudy 1 in Cohort 1.3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily', 'description': 'Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '20.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose and up to 9 months', 'description': 'ORR was defined by the percentage of patients with CR or PR by BICR according to RECIST Version 1.1.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all patients who received at least one dose of derazantinib and had at least one post-baseline imaging assessment in accordance with RECIST 1.1 or documented clinical progression or died from any cause on or after the first dose of study treatment and until safety follow-up visit (inclusive).'}, {'type': 'SECONDARY', 'title': 'Disease Control Rate (DCR) in Substudy 1: Cohort 1.1, 1.2 and 1.3 and Combined Cohorts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily', 'description': 'Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.'}, {'id': 'OG001', 'title': 'Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily', 'description': 'Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.'}, {'id': 'OG002', 'title': 'Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily', 'description': 'Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.'}, {'id': 'OG003', 'title': 'Substudy 1 Combined: Derazantinib 300 mg Once Daily or 200 mg Twice Daily', 'description': 'Derazantinib was administered orally at a dose of either 300 mg once daily or at a dose of 200 mg twice daily as monotherapy in Substudy 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000', 'lowerLimit': '11.3', 'upperLimit': '57.3'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '60.0'}, {'value': '15.4', 'groupId': 'OG002', 'lowerLimit': '2.8', 'upperLimit': '41.0'}, {'value': '23.5', 'groupId': 'OG003', 'lowerLimit': '12.3', 'upperLimit': '38.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose and up to 18 months', 'description': 'Defined as the percentage of patients with confirmed CR, PR or stable disease (SD) by BICR per RECIST version 1.1.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all patients who received at least one dose of derazantinib and had at least one post-baseline imaging assessment in accordance with RECIST 1.1 or documented clinical progression or died from any cause on or after the first dose of study treatment and until safety follow-up visit (inclusive).'}, {'type': 'SECONDARY', 'title': 'PFS in Substudy 1 in Cohort 1.3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily', 'description': 'Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '1.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose and up to 9 months', 'description': 'PFS was calculated from patient enrollment to progressive disease (PD) date by BICR per RECIST version 1.1', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all patients who received at least one dose of derazantinib and had at least one post-baseline imaging assessment in accordance with RECIST 1.1 or documented clinical progression or died from any cause on or after the first dose of study treatment and until safety follow-up visit (inclusive).'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) in Substudy 1 in Cohort 1.3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily', 'description': 'Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in Substudy 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '3.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose and up to 9 months', 'description': 'OS was measured from patient enrollment to time of death.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population comprised all patients enrolled and allocated to treatment, regardless of the administration of the study treatment.'}, {'type': 'SECONDARY', 'title': 'OS in Substudy 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Substudy 2: Derazantinib 200 mg Once Daily +Paclitaxel+ Ramucirumab', 'description': 'Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 200 mg in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.'}, {'id': 'OG001', 'title': 'Substudy 2: Derazantinib 300 mg Once Daily + Paclitaxel + Ramucirumab', 'description': 'Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'comment': 'Not evaluable due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not evaluable due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose and up to 15 months', 'description': 'OS was measured from patient enrollment to time of death', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population comprised all patients enrolled and allocated to treatment, regardless of the administration of the study treatment.'}, {'type': 'SECONDARY', 'title': 'ORR in Substudy 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Substudy 2: Derazantinib 200 mg Once Daily +Paclitaxel+ Ramucirumab', 'description': 'Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 200 mg once daily in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.'}, {'id': 'OG001', 'title': 'Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab', 'description': 'Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '81.1'}, {'value': '57.1', 'groupId': 'OG001', 'lowerLimit': '22.5', 'upperLimit': '87.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose and up to 15 months', 'description': 'ORR was defined by the percentage of patients with CR or PR by BICR per RECIST version 1.1.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all patients who received at least one dose of derazantinib and had at least one post-baseline imaging assessment in accordance with RECIST 1.1 or documented clinical progression or died from any cause on or after the first dose of study treatment and until safety follow-up visit (inclusive).'}, {'type': 'SECONDARY', 'title': 'DCR in Substudy 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Substudy 2: Derazantinib 200 mg Once Daily +Paclitaxel+ Ramucirumab', 'description': 'Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 200 mg once daily in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.'}, {'id': 'OG001', 'title': 'Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel + Ramucirumab', 'description': 'Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.'}, {'id': 'OG002', 'title': 'Substudy 2 Combined: Derazantinib +Paclitaxel+ Ramucirumab', 'description': 'Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of either 200 mg or 300 mg once daily in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.'}], 'classes': [{'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '34.3', 'upperLimit': '99.0'}, {'value': '71.4', 'groupId': 'OG001', 'lowerLimit': '34.1', 'upperLimit': '94.7'}, {'value': '75.0', 'groupId': 'OG002', 'lowerLimit': '47.3', 'upperLimit': '92.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first dose and up to 15 months', 'description': 'Defined as the percentage of patients with confirmed CR, PR or SD by BICR per RECIST version 1.1.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all patients who received at least one dose of derazantinib and had at least one post-baseline imaging assessment in accordance with RECIST 1.1 or documented clinical progression or died from any cause on or after the first dose of study treatment and until safety follow-up visit (inclusive).'}, {'type': 'SECONDARY', 'title': 'DOR in Substudy 2 (Separate and Combined Cohorts)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Substudy 2: Derazantinib 200 mg Once Daily +Paclitaxel+ Ramucirumab', 'description': 'Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 200 mg once daily in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.'}, {'id': 'OG001', 'title': 'Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab', 'description': 'Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of either 300 mg once daily or 200 mg twice daily in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.'}, {'id': 'OG002', 'title': 'Substudy 2 Combined: Derazantinib +Paclitaxel+ Ramucirumab', 'description': 'Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of either 200 mg or 300 mg once daily in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'comment': 'Only a low number of patients with CR or PR (2 patients) and low number of related events (high number of censoring and time of censoring) could be considered for the evaluation. As such, some parameters are impossible to be estimated or to be evaluated by the statistical method used (Kaplan-Meier).', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Only a low number of patients with CR or PR (4 patients) and low number of related events (high number of censoring and time of censoring) could be considered for the evaluation. As such, some parameters are impossible to be estimated or to be evaluated by the statistical method used (Kaplan-Meier).', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': 'NA'}, {'value': '9.2', 'comment': 'Only a low number of patients with CR or PR (2 and 4 patients from the 200 mg and 300 mg arm, respectively) and low number of related events (high number of censoring and time of censoring) could be considered for the evaluation. As such, some parameters are impossible to be estimated or to be evaluated by the statistical method used (Kaplan-Meier).', 'groupId': 'OG002', 'lowerLimit': '3.3', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose and up to 15 months', 'description': 'DOR was calculated from the first date of documented tumor response to disease progression by BICR per RECIST version 1.1 (or death if no documentation of PD is obtained).', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all patients who received at least one dose of derazantinib and had at least one post-baseline imaging assessment in accordance with RECIST 1.1 or documented clinical progression or died from any cause on or after the first dose of study treatment and until safety follow-up visit (inclusive).\n\nWithin the mITT, only patients with confirmed CR or PR have been considered for this endpoint (2 and 4 patients from the 200 mg and 300 mg arm, respectively)'}, {'type': 'SECONDARY', 'title': 'PFS in Substudy 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Substudy 2: Derazantinib 200 mg Once Daily +Paclitaxel+ Ramucirumab', 'description': 'Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 200 mg once daily in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.'}, {'id': 'OG001', 'title': 'Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab', 'description': 'Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'comment': 'Not evaluable due to the low number of events.', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not evaluable due to the low number of events.', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From first dose and up to 15 months', 'description': 'PFS was calculated from patient enrollment to progressive disease (PD) date by BICR per RECIST version 1.1.', 'unitOfMeasure': 'months', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT population: all patients who received at least one dose of derazantinib and had at least one post-baseline imaging assessment in accordance with RECIST 1.1 or documented clinical progression or died from any cause on or after the first dose of study treatment and until safety follow-up visit (inclusive).'}, {'type': 'SECONDARY', 'title': 'Number of Patients With at Least Grade 3 Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily', 'description': 'Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.'}, {'id': 'OG001', 'title': 'Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily', 'description': 'Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.'}, {'id': 'OG002', 'title': 'Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily', 'description': 'Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.'}, {'id': 'OG003', 'title': 'Substudy 2: Derazantinib 200 mg Once Daily +Paclitaxel+ Ramucirumab', 'description': 'Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 200 mg in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.'}, {'id': 'OG004', 'title': 'Substudy 2: Derazantinib 300 mg Once Daily +Paclitaxel+ Ramucirumab', 'description': 'Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.'}], 'classes': [{'title': 'Number of patients with only unrelated TEAEs of Grade 3 or above', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Number of patients with related TEAEs of Grade 3 or above', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Number of patients without TEAEs of Grade 3 or above', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': "TEAEs defined as AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months", 'description': 'Number of patients experiencing TEAE of Grade 3 and above according to Common Terminology Criteria for Adverse Events (CTCAE). CTCAE are a set of criteria for the standardized classification of TEAEs of drugs used in cancer therapy. It uses a range of grades from 1 to 5 describing increasing levels of severity of the TEAEs.', 'unitOfMeasure': 'Counts of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population comprises all patients who received at least one dose of study treatment (derazantinib, paclitaxel or ramucirumab).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily', 'description': 'Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.'}, {'id': 'FG001', 'title': 'Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily', 'description': 'Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.'}, {'id': 'FG002', 'title': 'Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily', 'description': 'Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.'}, {'id': 'FG003', 'title': 'Substudy 2: Derazantinib 200 mg Once Daily +Paclitaxel+ Ramucirumab', 'description': 'Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 200 mg in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.'}, {'id': 'FG004', 'title': 'Substudy 2: Derazantinib 300 mg Once Daily + Paclitaxel + Ramucirumab', 'description': 'Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'comment': 'One patient still received derazantinib while the study was early terminated and was transferred to a post-trial access program.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Progressive disease: Clinical progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Progressive disease: Radiological progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'From 6 Oct. 2020 to 10 Jun. 2022, 919 patients (pt.) had molecular pre-screening. 66 had clinical screening, and 47 were treated.\n\nIn Substudy 2, pt. were allocated to 1 of 3 dose levels using a dose escalation scheme: Derazantinib at a dose of 200 mg once daily, 300 mg once daily, or 200 mg twice daily, all in combination with paclitaxel and ramucirumab. However, no pt. received the highest dose, therefore only the 200 and 300 mg once daily dose levels are presented in the results section.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '47', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Substudy 1: Cohort 1.1 Derazantinib 300 mg Once Daily', 'description': 'Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.'}, {'id': 'BG001', 'title': 'Substudy 1: Cohort 1.2 Derazantinib 300 mg Once Daily', 'description': 'Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1.'}, {'id': 'BG002', 'title': 'Substudy 1: Cohort 1.3 Derazantinib 200 mg Twice Daily', 'description': 'Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1.'}, {'id': 'BG003', 'title': 'Substudy 2: Derazantinib 200 mg Once Daily +Paclitaxel+ Ramucirumab', 'description': 'Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 200 mg in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.'}, {'id': 'BG004', 'title': 'Substudy 2: Derazantinib 300 mg Once Daily+Paclitaxel+ Ramucirumab', 'description': 'Derazantinib-paclitaxel-ramucirumab combination: Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.5', 'spread': '10.77', 'groupId': 'BG000'}, {'value': '66.1', 'spread': '9.39', 'groupId': 'BG001'}, {'value': '54.8', 'spread': '13.43', 'groupId': 'BG002'}, {'value': '55.2', 'spread': '10.53', 'groupId': 'BG003'}, {'value': '52.0', 'spread': '11.34', 'groupId': 'BG004'}, {'value': '59.3', 'spread': '12.43', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '33', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}]}, {'title': 'Black/African American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '36', 'groupId': 'BG005'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-21', 'size': 14661394, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-21T05:40', 'hasProtocol': True}, {'date': '2022-12-12', 'size': 20955856, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-21T05:39', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'whyStopped': 'Terminated prematurely for administrative reasons not related to patient safety.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-06', 'studyFirstSubmitDate': '2020-10-21', 'resultsFirstSubmitDate': '2023-11-21', 'studyFirstSubmitQcDate': '2020-10-21', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-06', 'studyFirstPostDateStruct': {'date': '2020-10-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate (ORR) in Substudy 1 (in Cohorts 1.1 and 1.2)', 'timeFrame': 'From first dose and up to 18 months', 'description': 'ORR was defined by the percentage of patients with confirmed complete response (CR, which means disappearance of all target lesions) or partial response (PR, which means \\>=30% decrease in the sum of the longest diameter of target lesions) by blinded independent central review (BICR) using the internationally recognized criteria for the radiological assessment in tumor response of solid tumors (RECIST 1.1). Overall Response (OR) = CR + PR.\n\nThe patients in Cohort 1.1 had FGFR2 fusions or amplification gastric adenocarcinoma (GAC) and FGFR1-3 mutations GAC in Cohort 1.2.'}, {'measure': 'Progression-free Survival at 4 Months (PFS4) in Substudy 1 in Cohort 1.3', 'timeFrame': 'From first dose and up to 4 months', 'description': 'PFS4 was defined by the percentage of patients alive and free of disease progression (defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions) by BICR per RECIST. 1.1. Patients in this Cohort had FGFR fusions, amplifications or mutations GAC'}, {'measure': 'Recommended Phase 2 Dose (RP2D) in Substudy 2 (Derazantinib-paclitaxel-ramucirumab in Combination)', 'timeFrame': 'From first dose and up to 18 months', 'description': 'RP2D was determined from safety and tolerability according to the aggregate of dose-limiting toxicity criteria and adverse event (AE) data, and considering further pharmacokinetic and efficacy data of the derazantinib-paclitaxel-ramucirumab combination in patients with FGFR fusions, amplifications or mutations GAC.'}], 'secondaryOutcomes': [{'measure': 'ORR in Substudy 1 in Cohort 1.3', 'timeFrame': 'From first dose and up to 9 months', 'description': 'ORR was defined by the percentage of patients with CR or PR by BICR according to RECIST Version 1.1.'}, {'measure': 'Disease Control Rate (DCR) in Substudy 1: Cohort 1.1, 1.2 and 1.3 and Combined Cohorts', 'timeFrame': 'From first dose and up to 18 months', 'description': 'Defined as the percentage of patients with confirmed CR, PR or stable disease (SD) by BICR per RECIST version 1.1.'}, {'measure': 'PFS in Substudy 1 in Cohort 1.3', 'timeFrame': 'From first dose and up to 9 months', 'description': 'PFS was calculated from patient enrollment to progressive disease (PD) date by BICR per RECIST version 1.1'}, {'measure': 'Overall Survival (OS) in Substudy 1 in Cohort 1.3', 'timeFrame': 'From first dose and up to 9 months', 'description': 'OS was measured from patient enrollment to time of death.'}, {'measure': 'OS in Substudy 2', 'timeFrame': 'From first dose and up to 15 months', 'description': 'OS was measured from patient enrollment to time of death'}, {'measure': 'ORR in Substudy 2', 'timeFrame': 'From first dose and up to 15 months', 'description': 'ORR was defined by the percentage of patients with CR or PR by BICR per RECIST version 1.1.'}, {'measure': 'DCR in Substudy 2', 'timeFrame': 'From first dose and up to 15 months', 'description': 'Defined as the percentage of patients with confirmed CR, PR or SD by BICR per RECIST version 1.1.'}, {'measure': 'DOR in Substudy 2 (Separate and Combined Cohorts)', 'timeFrame': 'From first dose and up to 15 months', 'description': 'DOR was calculated from the first date of documented tumor response to disease progression by BICR per RECIST version 1.1 (or death if no documentation of PD is obtained).'}, {'measure': 'PFS in Substudy 2', 'timeFrame': 'From first dose and up to 15 months', 'description': 'PFS was calculated from patient enrollment to progressive disease (PD) date by BICR per RECIST version 1.1.'}, {'measure': 'Number of Patients With at Least Grade 3 Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': "TEAEs defined as AEs which were assessed per patient from the patient's first dose and until 90 days after the last dose, which corresponded up to 19 months", 'description': 'Number of patients experiencing TEAE of Grade 3 and above according to Common Terminology Criteria for Adverse Events (CTCAE). CTCAE are a set of criteria for the standardized classification of TEAEs of drugs used in cancer therapy. It uses a range of grades from 1 to 5 describing increasing levels of severity of the TEAEs.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric cancer', 'gastro-esophageal adenocarcinoma', 'adenocarcinoma of the stomach or gastro-esophageal junction', 'fibroblast growth factor receptor', 'FGFR genetic aberration', 'targeted therapy', 'derazantinib', 'atezolizumab', 'Tecentriq', 'paclitaxel', 'ramucirumab', 'Cyramza', 'solid tumor'], 'conditions': ['Gastric Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the efficacy of derazantinib monotherapy or derazantinib in combination with paclitaxel and ramucirumab in patients with gastric adenocarcinoma (GAC) i.e. with human epidermal growth factor receptor 2 (HER2)-negative adenocarcinoma of the stomach or gastro-esophageal junction harboring fibroblast growth factor receptor 2 (FGFR2) genetic aberrations (GA).', 'detailedDescription': 'The study comprised two open-label substudies in patients with HER2-negative adenocarcinoma of the stomach or gastro-esophageal junction harboring FGFR2 gene translocations, FGFR2 gene amplifications, or FGFR1-3 mutations.\n\nIn Substudy 1, GAC patients with specified FGFR GAs, after either first- or second-line treatment, and no approved treatment alternative were treated with derazantinib 300 mg once daily or 200 mg twice daily, with the aim of evaluating the safety, tolerability, and efficacy of derazantinib monotherapy in this patient population.\n\nIn Substudy 2, GAC patients with specified FGFR GAs after standard first-line treatment, were treated with a derazantinib-paclitaxel-ramucirumab combination with the aim of evaluating the safety, tolerability, and efficacy of the combination therapy and determining the recommended phase 2 dose (RP2D).\n\nThe study originally planned to include three substudies but was prematurely terminated for administrative reasons before the third substudy (including combination therapy with derazantinib plus atezolizumab) was initiated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main inclusion criteria\n\nPatients meeting all of the inclusion criteria at screening were eligible for enrollment in the study, including:\n\n1. Histologically-confirmed adenocarcinoma of the gastro-esophageal junction or stomach.\n2. Negative HER2 status obtained from the most recent available tissue sample.\n3. Inoperable recurrent, locally advanced adenocarcinoma or progressing stage IV adenocarcinoma of the gastro-esophageal junction or stomach, and prior anti-tumor treatment as specified for each Substudy. Patients were required to be staged as inoperable at the time of screening in order to avoid interference of any potentially planned surgery with RECIST requirements during the study:\n\n Substudy 1: Patients with radiographically documented disease progression after either standard first- or second-line treatment, and no approved and/or tolerable treatment alternative.\n\n Substudy 2: Patients with radiographically documented disease progression after standard first-line treatment, and per Investigator assessment considered suitable to tolerate the treatment regimen.\n4. Eligible FGFRfus/amp/mt positive test result. For Substudy 1 Cohort 1.1, FGFR2fus/amp; for Cohort 1.2, FGFR1-3mt; for Cohort 1.3, FGFRfus/amp/mt. For Substudy 2, FGFRfus/amp/mt.\n5. Measurable disease as defined by the Investigator using RECIST 1.1 criteria\n6. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1\n7. Adequate organ functions as indicated by Screening visit laboratory values.\n\nMain exclusion criteria\n\nPatients meeting any of the following exclusion criteria at screening were not eligible to be enrolled in the study:\n\n* Receipt of prior cancer treatment within specific interval periods.\n* For patients enrolled in Substudy 1, prior treatment with FGFR inhibitors.\n* For patients enrolled in Substudy 2, prior treatment with:\n\n * Taxanes within 6 months prior to randomization\n * FGFR inhibitors or pathway-targeting agents\n * Anti-VEGF(R) therapeutic antibody or pathway-targeting agents\n* Concurrent evidence of clinically significant corneal or retinal disorder likely to increase the risk of eye toxicity, including but not limited to bullous/band keratopathy, keratoconjunctivitis (unless keratoconjunctivitis sicca), corneal abrasion (unless related to trauma), inflammation/ulceration, confirmed by ophthalmological examination.\n* History of clinically significant cardiac disorders, including myocardial infarction, or New York Heart Association Class II to IV congestive heart failure, within 6 months of the first dose of study drug, and/or any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months of the first dose of study drug, and/or concurrent and clinically significant abnormalities on ECG at Screening, including QTcF \\> 450 ms for males or \\> 460 ms for females (mean values from triplicate ECGs).\n* Any unresolved (at the time of Screening) clinically significant CTCAE Grade ≥ 2 toxicity (except for alopecia, Grade ≤ 2 platinum-therapy related neuropathy, or Grade ≤ 2 anemia from previous anti-tumor treatment and/or from medical/surgical procedures/interventions).\n* Known central nervous system metastases.\n* Severe bacterial, fungal, viral and/or parasitic infections on therapeutic oral or IV medication at the time of first dose of study drug administration.\n* Significant gastrointestinal disorders that could interfere with the absorption, metabolism, or excretion of derazantinib.\n* History of additional malignancy that was progressing or required active treatment.'}, 'identificationModule': {'nctId': 'NCT04604132', 'acronym': 'FIDES-03', 'briefTitle': 'Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Basilea Pharmaceutica'}, 'officialTitle': 'A Phase 1b/2 Study of Derazantinib as Monotherapy and Combination Therapy With Paclitaxel, Ramucirumab or Atezolizumab in Patients With HER2-negative Gastric Adenocarcinoma Expressing FGFR2 Genetic Aberrations', 'orgStudyIdInfo': {'id': 'DZB-CS-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Substudy 1: Cohort 1.1 Derazantinib 300 mg once daily', 'description': 'Patients with FGFR2 fusions or amplifications were treated with 300 mg Derazantinib monotherapy once daily', 'interventionNames': ['Drug: Derazantinib']}, {'type': 'EXPERIMENTAL', 'label': 'Substudy 1: Cohort 1.2 Derazantinib 300 mg once daily', 'description': 'Patients with FGFR1-3 mutations were treated with 300 mg Derazantinib monotherapy once daily', 'interventionNames': ['Drug: Derazantinib']}, {'type': 'EXPERIMENTAL', 'label': 'Substudy 1: Cohort 1.3 Derazantinib 200 mg twice daily', 'description': 'Patients with FGFR fusions, amplifications or mutations were treated with 200 mg Derazantinib monotherapy twice daily', 'interventionNames': ['Drug: Derazantinib']}, {'type': 'EXPERIMENTAL', 'label': 'Substudy 2: Derazantinib 200 mg once daily +Paclitaxel+ Ramucirumab', 'description': 'Patients with FGFR fusions, amplifications or mutations were treated with 200 mg Derazantinib once daily in combination with Paclitaxel and Ramucirumab', 'interventionNames': ['Drug: Derazantinib-paclitaxel-ramucirumab combination']}, {'type': 'EXPERIMENTAL', 'label': 'Substudy 2: Derazantinib 300 mg once daily+Paclitaxel+ Ramucirumab', 'description': 'Patients with FGFR fusions, amplifications or mutations were treated with 300 mg Derazantinib once daily combination with Paclitaxel and Ramucirumab', 'interventionNames': ['Drug: Derazantinib-paclitaxel-ramucirumab combination']}], 'interventions': [{'name': 'Derazantinib', 'type': 'DRUG', 'description': 'Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1 (Cohort 1.1).', 'armGroupLabels': ['Substudy 1: Cohort 1.1 Derazantinib 300 mg once daily']}, {'name': 'Derazantinib-paclitaxel-ramucirumab combination', 'type': 'DRUG', 'description': 'Derazantinib was administered orally at a dose of 200 mg once daily in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.', 'armGroupLabels': ['Substudy 2: Derazantinib 200 mg once daily +Paclitaxel+ Ramucirumab']}, {'name': 'Derazantinib-paclitaxel-ramucirumab combination', 'type': 'DRUG', 'description': 'Derazantinib was administered orally at a dose of 300 mg once daily in combination with paclitaxel and ramucirumab.\n\nPaclitaxel was administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.\n\nRamucirumab was administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel.', 'armGroupLabels': ['Substudy 2: Derazantinib 300 mg once daily+Paclitaxel+ Ramucirumab']}, {'name': 'Derazantinib', 'type': 'DRUG', 'description': 'Derazantinib was administered orally at a dose of 200 mg twice daily as monotherapy in the Substudy 1 (Cohort 1.3).', 'armGroupLabels': ['Substudy 1: Cohort 1.3 Derazantinib 200 mg twice daily']}, {'name': 'Derazantinib', 'type': 'DRUG', 'description': 'Derazantinib was administered orally at a dose of 300 mg once daily as monotherapy in the Substudy 1 (Cohort 1.2).', 'armGroupLabels': ['Substudy 1: Cohort 1.2 Derazantinib 300 mg once daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Cancer Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': 'C1093AAS', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Fundación Favaloro para la Docencia e Investigación Médica', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'B1264AAA', 'city': 'Ciudad Autonoma Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo'}, {'zip': '3168', 'city': 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