ISRCTN15566373已完成1 期
Phase I dose-escalation of S 95005 (TAS-102) in combination with oxaliplatin in metastatic colorectal cancer
Servier (France)0 个研究点目标入组 78 人开始时间: 2016年3月2日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 78
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
- 性别
- All
入选标准
- •Inclusion criteria as of 24/11/2016:
- •1. Age 18 years or older
- •2. Histologically confirmed metastatic colorectal cancer pretreated by at least one line of standard chemotherapy
- •3. Restaging scan within 28 days before the first study drug intake
- •4. During the dose-escalation part, patient must have at least one evaluable or measurable metastatic lesion; and during the expansion part, patient must have at least one measurable metastatic lesion
- •5. Life expectancy of more than 3 months
- •6. Performance status Eastern Cooperative Oncology Group (ECOG): 0-1
- •7. Adequate bone marrow, liver, and kidney function
- •8. For patient who will receive bevacizumab: coagulation parameters in normal limit or in therapeutic limit for patients treated with anticoagulant
- •9. Women of childbearing potential must have a negative pregnancy test. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use highly effective birth control method. Women and female partners using hormonal contraceptive must also use a barrier method.
- •10. Capacity to take oral tablet(s) without difficulty
- •11. Has provided written informed consent
- •12. Is willing and able to comply with scheduled visits and study procedures
- •Added 06/04/2017: For patients who will receive nivolumab: patients eligible for tumour biopsy and who agree to have two sequential biopsies during the study
- •Original inclusion criteria:
- •1. Age 18 years or older
- •2. Histologically confirmed metastatic colorectal cancer pretreated by at least one line of standard chemotherapy and naïve to oxaliplatin in the metastatic setting
- •3. Restaging scan within 28 days before the first study drug intake
- •4. During the dose-escalation part, patient must have at least one evaluable or measurable metastatic lesion; and during the expansion part, patient must have at least one measurable metastatic lesion
- •5. Life expectancy of more than 3 months
- •6. Performance status Eastern Cooperative Oncology Group (ECOG): 0-1
- •7. Adequate bone marrow, liver, and kidney function
- •8. For patient who will receive bevacizumab: coagulation parameters in normal limit and adequate proteinuria
- •9. Women of childbearing potential must have a negative pregnancy test
- •Both males and females must agree to use effective birth control method
- •10. Capacity to take oral tablet(s) without difficulty
- •11. Has provided written informed consent
- •12. Is willing and able to comply with scheduled visits and study procedures
排除标准
- •Exclusion criteria as of 05/04/2017:
- •1. Grade 2 or higher peripheral neuropathy
- •2. During expansion part, patients who had recurrence during or within 6 months of completion of the adjuvant chemotherapy with oxaliplatin
- •3. Patients with brain metastases or leptomeningeal metastasis
- •4. Other active malignancy within the last 3 years (except for basal cell carcinoma or a non-invasive/in situ cervical cancer)
- •5. Has had certain other recent treatment e.g. major surgery, field radiation, participation in another interventional study within the specified time frames prior to study drug administration
- •6. For patient who will receive bevacizumab: history of allergic reactions/hypersensitivity to bevacizumab to any components used in the formulation, to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies.
- •7. Grade 3 or higher hypersensitivity reaction to oxaliplatin, or grade 1-2 hypersensitivity reaction to oxaliplatin not controlled with premedication
- •8. Patient previously treated by S 95005 or history of allergic reactions attributed to compounds of similar or biologic composition to S 95005 or any of its excipient, or has rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
- •9. Certain serious illnesses or serious medical conditions
- •10. Any condition that, in the judgment of the Investigator, may affect the patient's ability to understand and sign the informed consent and fully comply with all study procedure
- •11. Pregnancy or breast feeding
- •12. For patients planned to receive nivolumab:
- •12.1. Patients with active autoimmune disease or history of clinically severe autoimmune disease.
- •12.2. Patients with a condition requiring systemic treatment with either corticosteroids (> 20 mg daily prednisone equivalent) or other immunosuppressive medications within the specified time frames prior to first study drugs intake.
- •12.3. Prior treatment with anti-PD-1, anti-PD-L1, anti-programmed cell death ligand-2, anti-CD137, anti-OX-40, anti-CD40, anti-cytotoxic T lymphocyte-associated antigen-4 antibodies (CTLA-4), or any other immune checkpoint inhibitors.
- •12.4. Prior events of immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis and renal dysfunction, immune-mediated rash, immune-mediated encephalitis.
- •12.5. Allergic reactions/hypersensitivity to nivolumab or any components used in its formulation or previous severe hypersensitivity reaction to treatment with another monoclonal antibody.
- •12.6. Has a known history of active tuberculosis (Bacillus Tuberculosis).
- •Exclusion criteria as of 24/11/2016:
- •1. Grade 2 or higher peripheral neuropathy
- •2. During expansion part, patients who had recurrence during or within 6 months of completion of the adjuvant chemotherapy with oxaliplatin
- •3. Patients with brain metastases or leptomeningeal metastasis
- •4. Other active malignancy within the last 3 years (except for basal cell carcinoma or a non-invasive/in situ cervical cancer)
- •5. Has had
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