EUCTR2017-004509-42-GB进行中（未招募）1 期
A Phase Ib/ II Trial to Assess the Safety and Efficacy of CXD101 in Combination with the PD-1 Inhibitor Nivolumab in Patients with Metastatic, Previously-Treated, Microsatellite-Stable Colorectal Carcinoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-Written informed consent
- •-Biopsy-confirmed MSS, Mismatch Repair proficient (MMR-P) CRC
- •-Previous first and second line treatment/adjuvant therapy, including use of oxaliplatin and irinotecan unless documented intolerance of these
- •-Measurable disease: longest diameter=10mm (short axis =15mm for nodal lesions)
- •-Age >= 18 years
- •-Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
- •-Predicted life expectancy > 3 months
- •-Adequate organ and bone marrow function: Hb> 10.0g/dL (may be transfused to this level), neutrophils> 1.5x10^9/L and platelets> 100x10^9/L
- •-Female patients with reproductive potential must have a negative urine and serum pregnancy test prior to starting treatment.
- •-Both women of reproductive potential and men must agree to use a medically acceptable method of contraception throughout the treatment period and for 5 months after discontinuation of treatment
- •-All males with partners of childbearing potential or whose partners are pregnant must use barrier contraception for the duration of dosing and for 5 months post-dosing.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 26
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 29
排除标准
- •-Pregnant or breast feeding
- •-Pre-existing auto-immune conditions
- •-Medical conditions requiring systemic immunosuppression
- •-Previous treatment with an HDAC inhibitor or PD1/PDL1 inhibitor
- •-Other chemotherapy, radiotherapy, or investigational therapy within 4 weeks prior to the Screening /Baseline Assessment
- •-Unresolved clinically significant toxicity from a previous treatment
- •-History of recent active chronic inflammatory bowel disease and/or bowel obstruction
- •-Renal function: Serum creatinine >= 1.5 x ULN, or creatinine clearance < 60mL/min (Cockcroft-Gault formula)
- •-Liver function: AST > 3.0; OR total bilirubin >1.5 x ULN. For subjects with involvement of metastatic liver disease: AST > 5.0 x ULN; OR total bilirubin > 3.0 x ULN
- •-Clinically significant myocardial infarction, severe/unstable angina pectoris, congestive heart failure NYHA Class III or IV, or pulmonary disease within 6 months
- •-Symptomatic brain metastasis, uncontrolled seizure disorder, spinal cord compression, or carcinomatous meningitis
- •-Clinically significant active infection requiring antibiotic or antiretroviral therapy
- •-History of malignancy other than MSS CRC, unless there is the expectation that the malignancy has been cured, and tumour specific treatment for the malignancy has not been administered within the previous 5 years
- •-History of pneumonitis, immune hepatitis or myocarditis, or current uncontrolled thyroid disease
- •-Current positive serology for Hepatitis B or C virus
- •-History of any allergy to excipients of the Investigational Medicinal Products (sodium citrate dihydrate, sodium chloride, mannitol, pentetic acid, Polysorbate 80, sodium hydroxide, hydrochloric acid, hydroxypropyl methylcellulose)
- •-Receipt of any live vaccine 30 days or fewer prior to administration of first dose IMP
- •-Inability to comply with the study protocol
研究者
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