NL-OMON52901已完成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
- 已完成
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- Written informed consent obtained
- •- Male or female participant aged >=18 years old at the time of ICF signature
- •(or legal age depending on local country regulation).
- •- Has definitive histologically confirmed adenocarcinoma of the colon or rectum.
- •- Has at least one measurable metastatic lesion.
- •- RAS status based on local biological assessment of tumour biopsy must be
- •- Patient is not a candidate for standard full dose combination chemotherapy
- •with irinotecan or oxaliplatin according to investigator*s judgment and
- •decision taken during a multidisciplinary meeting (if organised in the centre).
- •Reasons for non-eligibility to these standard treatments could be, but are not
- •limited to, age, performance status, low tumour burden, comorbidities or
- •non-clinical reasons.
- •- Patient is not a candidate for curative resection of metastatic lesions
- •according to investigator*s judgment and decision taken during a
- •multidisciplinary meeting (if organised in the centre).
- •- No previous systemic anticancer therapy for unresectable metastatic
- •colorectal cancer. Previous adjuvant or neoadjuvant chemotherapy is allowed
- •only if the patient has been disease free for at least 6 months after the
- •completion of the chemotherapy.
- •- Ability to swallow oral medication.
- •- Estimated life expectancy >=12 weeks.
- •- ECOG (Eastern Cooperative Oncology Group) performance status <=2.
- •- Adequate haematological, renal, hepatic and coagulation function.
- •- Women of childbearing potential must have been tested negative in a serum
- •pregnancy test. Within the frame of this study, female participants of
- •childbearing potential and male participants with partner of childbearing
- •potential must use an highly effective method of birth control as well as their
- •partners lasting at least 6 months after the last dose of IMP. Women using
- •hormonal contraceptive must also use a barrier method.
排除标准
- •- Unlikely to cooperate in the study.
- •- Pregnancy, breastfeeding or possibility of becoming pregnant during the study.
- •- Participation in another interventional study, major surgery, drainage for
- •ascites, pleural effusion or pericardial fluid, previous radiotherapy, within
- •the specified timeframes 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.
- •- Has certain serious illness or serious medical condition(s) described in the
- •- Hereditary problems of galactose intolerance, the Lapp lactase deficiency or
- •glucose-galactose malabsorption.
- •- Other malignancies excluding malignancies that are in remission for more than
- •5 years, cervix carcinoma-in-situ deemed cured by adequate treatment or basal
- •cell carcinoma.
- •- Treatment with systemic immunosuppressive therapy (except steroids given in
- •prophylactic setting or at a chronic low dose (<=20mg/day prednisone
- •equivalent)).
- •- Criteria related to S 95005 administration:
- •Has previously received S 95005.
- •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.
- •- Criteria related to bevacizumab administration:
- •History of allergic reactions or hypersensitivity to bevacizumab or any of its
- •excipients.
- •History of hypersensitivity to Chinese Hamster Ovary (CHO) cell products or
- •other recombinant human or humanised antibodies.
- •Serious non-healing wound, non-healing ulcer or non-healing bone fracture.
- •Deep venous thromboembolic event within 4 weeks prior to randomisation.
- •Known coagulopathy that increases risk of bleeding, bleeding diatheses. Any
- •other haemorrhage/bleeding event CTCAE grade >= 3 within 4 weeks prior to
- •randomisation.
- •Any contraindication present in the SmPC of bevacizumab.
- •- Criteria related to capecitabine administration:
- •History of allergic reactions or hypersensitivity to capecitabine or any of its
- •excipients or fluorouracil.
- •History of severe and unexpected reaction to fluoropyrimidine therapy.
- •Known complete absence of dihydropyrimidine dehydrogenase (DPD) activity or
- •partial deficiency of DPD preventing the administration of the starting dose of
- •capecitabine as defined per study protocol.
- •Treatment with sorivudine or its chemical related analogues, such as brivudine,
- •within 4 weeks prior to the randomisation.
- •Any contraindication present in the SmPC of capecitabine.
研究者
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