EUCTR2018-001295-37-BE进行中（未招募）1 期
CILOSTAZOL AS IMATINIB SYNERGISER IN PATIENTS WITH UNRESECTABLE OR METASTATIC GIST TREATED BY GLIVEC® - CILOGIST
CUB HOPITAL ERASME0 个研究点目标入组 10 人开始时间: 2018年8月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
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
- 性别
- All
入选标准
- •Inclusion Criteria:
- •-histologically proven metastatic or locally advanced histologically proven non resectable GIST ( any primary tumor site) already treated by Glivec® (at any dose) for at least 12 months in first line therapy, or patients who will start Glivec® (at any dose) in first line therapy or after failure of all TKIs
- •-exon 11, exon 9 or other kit mutations
- •-written signed informed consent
- •-ability to take oral medication
- •-metabolic positivity of the tumor at the first PET-CT (positivity is defined as High 18F-FDG uptake by a lesion more than the surrounding tissue)
- •-at least one measurable lesion by CT scanner
- •-no contraindication to cilostazol
- •-ECOG performance status 0 /1 at study entry
- •-effective contraception for both male and female patients must be used for at least 8 weeks after the last study drug administration if the risk of conception exists
- •-age > 18 years old
- •-life expectancy at least 12 weeks
- •- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment:
- •oSerum creatinine <1.5x upper reference range
- •oTotal bilirubin <1.5x ULN
- •oAlanine transaminase (ALT) and aspartate aminotransferase (AST) < 2.5x ULN (<5x ULN for patients with liver involvement of their cancer).
- •oAmylase and lipase <1.5x ULN.
- •oINR<1.5x ULN
- •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 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Exclusion Criteria:
- •-PDGFR&D842V mutation
- •-Wild-type tumors
- •-unability to take oral medication
- •-any malabsorption condition
- •-previous exposure to cilostazol or PDE3 inhibitor or any other phosphodiesterase inhibitor
- •-known hypersensitivity to any of the components of study treatments
- •-previous malignancy in the last past 5 years except basal cell cancer of the skin or preinvasive cancer of the cervix
- •-pregnancy or breast feeding
- •-medical or psychological conditions that would not permit the patient to complete the study or sign inform consent
- •-patients receiving or having received any investigational treatment within 4 weeks prior to study entry, or participating to another clinical study
- •- history of organ allograft
- •-ongoing infection HIV infection
- •-liver failure, cirrhosis Child Pugh B or C
- •-active chronic hepatitis B or C with a need for antiviral treatment
- •-heart failure any NYHA class
- •-grapefruit juice consumption
- •-hemodialysis
- •-active bleeding disorder or coagulation disorder
- •-uncontrolled concurrent CNS, cardiac, infectious diseases
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