Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2026-03-19 @ 7:15 AM
Study NCT ID:
NCT03869892
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2018-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.
Sponsor:
Organization:
Raw JSON
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For functional scores, a higher score represents an increase in functioning. For symptom scores, a higher score represents an increase in symptoms.'}, {'measure': 'Quality of life as assessed by EQ-5D-5L', 'timeFrame': 'Up to 8 years', 'description': 'The 5-level EQ-5D version questionnaire scores range from 5 to 25 with a higher score representing a worse health status.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metastatic', 'Cancer', 'Colorectal', 'Colorectal Cancer', 'Colon', 'Rectum', 'Metastasis'], 'conditions': ['Metastatic Colorectal Cancer']}, 'referencesModule': {'availIpds': [{'url': 'https://clinicaltrials.servier.com/', 'type': 'Individual Participant Data Set'}, {'url': 'https://clinicaltrials.servier.com/', 'type': 'Study Protocol'}, {'url': 'https://clinicaltrials.servier.com/', 'type': 'Statistical Analysis Plan'}, {'url': 'https://clinicaltrials.servier.com/', 'type': 'Informed Consent Form'}, {'url': 'https://clinicaltrials.servier.com/', 'type': 'Clinical Study Report'}, {'url': 'https://clinicaltrials.servier.com/', 'type': 'study-level clinical trial data'}], 'references': [{'pmid': '36470291', 'type': 'BACKGROUND', 'citation': 'Andre T, Falcone A, Shparyk Y, Moiseenko F, Polo-Marques E, Csoszi T, Campos-Bragagnoli A, Liposits G, Chmielowska E, Aubel P, Martin L, Fougeray R, Amellal N, Saunders MP. Trifluridine-tipiracil plus bevacizumab versus capecitabine plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer ineligible for intensive therapy (SOLSTICE): a randomised, open-label phase 3 study. Lancet Gastroenterol Hepatol. 2023 Feb;8(2):133-144. doi: 10.1016/S2468-1253(22)00334-X. Epub 2022 Dec 2.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Has definitive histologically confirmed adenocarcinoma of the colon or rectum (all other histological types are excluded). Primary tumour localisation must be known.\n2. RAS status based on local biological assessment of tumour biopsy must be available. If RAS status is not available at the time of randomisation, tumour biopsy must be available for RAS status determination (based on local biological assessment).\n3. Patient is not a candidate for standard full dose combination chemotherapy with irinotecan or oxaliplatin\n4. Patient is not a candidate for curative resection of metastatic lesions.\n5. No previous systemic anticancer therapy for unresectable metastatic colorectal cancer.\n6. ECOG (Eastern Cooperative Oncology Group) performance status ≤2.\n7. Adequate organ function (renal, haematological, hepatic, coagulation) as described in the study protocol'\n\n Exclusion Criteria:\n8. Pregnancy, breastfeeding or possibility of becoming pregnant during the study.\n9. Participation in another interventional study within 4 weeks prior to the randomisation .\n10. Patients who have not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to the randomisation.\n11. Symptomatic central nervous system metastases.\n12. Major surgery within 4 weeks prior to the randomisation.\n\n Exclusion criteria related to S 95005 administration:\n13. History of allergic reactions attributed to compounds of similar composition to S 95005 or any of its excipients.\n14. Any contraindication present in the SmPC of trifluridine/tipiracil\n\n Exclusion criteria related to bevacizumab administration:\n15. Any contraindication present in the SmPC of bevacizumab\n\n Exclusion criteria related to capecitabine administration:\n16. Any contraindication present in the SmPC of capecitabine"}, 'identificationModule': {'nctId': 'NCT03869892', 'acronym': 'SOLSTICE', 'briefTitle': 'Phase III Study in First-line Treatment of Patients With Metastatic Colorectal Cancer Who Are Not Candidate for Intensive Therapy.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Servier'}, 'officialTitle': 'An Open-label, Randomised, Phase III Study cOmparing trifLuridine/Tipiracil (S 95005) in Combination With Bevacizumab to Capecitabine in Combination With Bevacizumab in firST-line Treatment of Patients With metastatIC Colorectal Cancer Who Are Not candidatE for Intensive Therapy (SOLSTICE Study)', 'orgStudyIdInfo': {'id': 'CL3-95005-006'}, 'secondaryIdInfos': [{'id': '2017-004059-22', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1206-3198', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'S95005 + Bevacizumab', 'interventionNames': ['Drug: Trifluridine/tipiracil hydrochloride (S95005)', 'Biological: Bevacizumab experimental']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Capecitabine + Bevacizumab', 'interventionNames': ['Drug: Capecitabine', 'Biological: Bevacizumab control']}], 'interventions': [{'name': 'Trifluridine/tipiracil hydrochloride (S95005)', 'type': 'DRUG', 'description': 'Film-coated tablets of S 95005 (35 mg/m²/dose) will be administered orally twice a day (BID), within 1 hour after completion of morning and evening meals, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest; This treatment cycle will be repeated every 4 weeks.', 'armGroupLabels': ['S95005 + Bevacizumab']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'Film-coated tablets, Capecitabine (1250 mg/m²/dose) will be administered orally BID on Days 1-14 of each cycle. This treatment cycle will be repeated every 3 weeks.', 'armGroupLabels': ['Capecitabine + Bevacizumab']}, {'name': 'Bevacizumab experimental', 'type': 'BIOLOGICAL', 'description': 'Concentrate for solution for infusion, Bevacizumab (5 mg/kg, IV) administered every 2 weeks (Day 1 and Day 15). This treatment cycle will be repeated every 4 weeks.', 'armGroupLabels': ['S95005 + Bevacizumab']}, {'name': 'Bevacizumab control', 'type': 'BIOLOGICAL', 'description': 'Concentrate for solution for infusion, Bevacizumab (7.5 mg/kg, IV) will be administered on Day 1 of each cycle.This treatment cycle will be repeated every 3 weeks.', 'armGroupLabels': ['Capecitabine + Bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B1884BBF', 'city': 'Berazategui', 'country': 'Argentina', 'facility': 'Centro de Oncología e Investigación de Buenos Aires COIBA', 'geoPoint': {'lat': -34.76531, 'lon': -58.21278}}, {'zip': '1264', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital de Gastroenterología Dr. Carlos Borino Udaondo Oncology Unit', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1093AAS', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Fundación Favaloro Oncology Unit', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1426ANZ', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Instituto Alexander Fleming', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1431FWO', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital Universitario CEMIC Servicio de Oncología, Unidad de tumores gastrointestinales', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'F5300COE', 'city': 'La Rioja', 'country': 'Argentina', 'facility': 'Centro Oncológico Riojano Integral CORI Fundación CORI para la Investigación y Prevención del Cáncer', 'geoPoint': {'lat': -29.41328, 'lon': -66.85637}}, {'zip': '5500', 'city': 'Mendoza', 'country': 'Argentina', 'facility': 'Fundación COIR Centro Oncológico de Interación Regional', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'zip': 'T4000IAK', 'city': 'San Miguel de Tucumán', 'country': 'Argentina', 'facility': 'Centro Médico San Roque', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': 'S2000KZE', 'city': 'Santa Fe', 'country': 'Argentina', 'facility': 'Instituto de Oncología de Rosario', 'geoPoint': {'lat': -31.64881, 'lon': -60.70868}}, {'zip': 'S3000FFU', 'city': 'Santa Fe', 'country': 'Argentina', 'facility': 'ISIS Centro especializado', 'geoPoint': {'lat': -31.64881, 'lon': -60.70868}}, {'zip': '2148', 'city': 'Blacktown', 'country': 'Australia', 'facility': 'Blacktown Hospital Cancer and Haematology Centre', 'geoPoint': {'lat': -33.76667, 'lon': 150.91667}}, {'zip': '3199', 'city': 'Frankston', 'country': 'Australia', 'facility': 'Frankston Private Peninsula and Southeast Oncology Group', 'geoPoint': {'lat': -38.14458, 'lon': 145.12291}}, {'zip': '2290', 'city': 'Gateshead', 'country': 'Australia', 'facility': 'Lake Macquarie Private Hospital', 'geoPoint': {'lat': -32.98208, 'lon': 151.69188}}, {'zip': '2217', 'city': 'Kogarah', 'country': 'Australia', 'facility': 'St George Hospital St George Hospital Cancer Care Centre', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '2076', 'city': 'Wahroonga', 'country': 'Australia', 'facility': 'Adventist HealthCare Integrated Cancer Centre', 'geoPoint': {'lat': -33.71816, 'lon': 151.11561}}, {'zip': '2500', 'city': 'Wollongong', 'country': 'Australia', 'facility': 'Southern Medical Day Care Centre', 'geoPoint': {'lat': -34.424, 'lon': 150.89345}}, {'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Med. 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