2024-516180-85-00招募中3 期
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).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 4
- 主要终点
- Progression-free survival (PFS) based on investigator judgement
研究概览
简要总结
To demonstrate the superiority of S 95005 in combination with bevacizumab over capecitabine in combination with bevacizumab in terms of progression-free survival (PFS) based on Investigator assessment in first-line treatment of patients with unrespectable metastatic colorectal cancer who are not candidate for intensive therapy.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Comparing S95005 combination with bevacizumab versus capecitabine in combination with bevacizumab
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Has definitive histologically confirmed adenocarcinoma of the colon or rectum (all other histological types are excluded). Primary tumour localisation must be known.
- •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).
- •Patient is not a candidate for standard full dose combination chemotherapy with irinotecan or oxaliplatin
- •Patient is not a candidate for curative resection of metastatic lesions
- •No previous systemic anticancer therapy for unresectable metastatic colorectal cancer
- •ECOG (Eastern Cooperative Oncology Group) performance status ≤
- •Adequate organ function (renal, haematological, hepatic, coagulation) as described in the study protocol'
排除标准
- •Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
- •Participation in another interventional study within 4 weeks prior to the randomisation .
- •Patients who have not recovered from clinically relevant non-hematologic CTCAE grade ≥ 3 toxicity of previous anticancer therapy prior to the randomisation.
- •Symptomatic central nervous system metastases.
- •Major surgery within 4 weeks prior to the randomisation.
- •Exclusion criteria related to S 95005 administration: History of allergic reactions attributed to compounds of similar composition to S 95005 or any of its excipients.
- •Any contraindication present in the SmPC of trifluridine/tipiracil
- •Exclusion criteria related to bevacizumab administration: Any contraindication present in the SmPC of bevacizumab
- •Exclusion criteria related to capecitabine administration: Any contraindication present in the SmPC of capecitabine
结局指标
主要结局
Progression-free survival (PFS) based on investigator judgement
Progression-free survival (PFS) based on investigator judgement
次要结局
- Overall survival (OS)
- Overall response rate (ORR)
- Disease control rate (DCR)
- Duration of response (DoR)
- Time to treatment failure (TTF)
- Safety and tolerability assessed by incidence of adverse events (AE), laboratory tests, physical examination and performance status (ECOG), vital signs, 12-leads ECG parameters
- Quality of life (QoL)
研究者
Clinical Studies Department
Scientific
Institut De Recherches Internationales Servier IRIS
研究点 (4)
Loading locations...
相似试验
招募中
2 期
BEACON: A randomised phase IIb trial of BEvACizumab added to Temozolomide ± IrinOtecan for children with refractory/relapsed NeuroblastomaNeuroblastoma2024-518931-12-00The University Of Birmingham122
尚未招募
不适用
Chimiothérapie à base de bevacizumab adaptée à la pharmacocinétique du bevacizumab en 1ère ligne de traitement du cancer colorectal métastatique non résécable : étude de phase 3 randomisée multicentrique en double aveugle.2023-507873-16-00Centre Hospitalier Regional Universitaire De Tours122
招募中
3 期
An open-label clinical trial evaluating enfortumab vedotin in combination with pembrolizumab versus chemotherapy alone in previously untreated locally advanced or metastatic urothelial cancer2023-503421-19-00Seagen Inc.703
已完成
3 期
Pembrolizumab with Lenvatinib versus Docetaxel for Metastatic NSCLC after Platinum Doublet Chemotherapy and Immunotherapy2022-501439-18-00Merck Sharp & Dohme LLC206
招募中
3 期
Phase III Study of Rilvegostomig in Combination withBevacizumab with or without Tremelimumab as First-lineTreatment of Hepatocellular Carcinoma2024-518210-81-00AstraZeneca AB273