EUCTR2015-004240-19-DK进行中（未招募）1 期
A randomized double-blind placebo-controlled study with ASA treatment incolorectal cancer patients with mutations in the PI3K signaling pathway
Karolinska University Hospital, Department of Molecular medicine and Surgery Karolinska Institutet, Gastrocentrum0 个研究点目标入组 600 人开始时间: 2017年2月23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
- 600
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
- •Tumor with somatic alterations in PIK3CA, PIK3R1 or PTEN
- •- Colon or rectal cancer tumor stage II-III
- •- Patient between18-80 years (including)
- •- Radical surgery according to surgeon and pathologist
- •- Karnofsky performance status =70%
- •- Platelets = 100 x 109 / L
- •- Clean Colonoscopy or Computed Tomography (CT) colon within 3
- •months preoperatively or postoperatively but before randomization
- •- Patient able to swallow tablets
- •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 240
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 360
排除标准
- •Hereditary colorectal cancer linked to familial colonic polyposis or
- •Lynch syndrome
- •- Inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- •- Distant metastases
- •- Other cancers (excluding colorectal cancer or other skin cancer than
- •melanoma) within 3 years from screening
- •- Known bleeding diathesis (such as hemophilia)
- •- Concomitant antiplatelet therapy (eg clopidrogrel or ticlopidine) or
- •anticoagulant therapy (warfarin or low molecular weight heparin).
- •Postoperative
- •treatment with low molecular weight heparin must be
- •withdrawn before administration of study treatment
- •- Active gastritis or peptic ulcer, or significant surgical post-op bleeding,
- •within the previous three months assessed at screening and
- •randomization
- •- Ongoing regular use of corticosteroids, Nonsteroidal Anti-Inflammatory
- •Drug (NSAID)
- •- Uncontrolled hypertension according to Investigator's judgment
- •- Clinically significant liver impairment according to Investigators
- •- Existing renal failure according to Investigator's judgment. Renal
- •failure with decreased creatinine clearance <60 should lead to
- •consultation with a nephrologist.
- •- Significant medical illness that would interfere with study participation
- •- Pregnancy or breastfeeding females
- •- Known allergy to NSAIDs or ASA
- •- Current participation in another clinical trial that will be in conflict with
- •the present study
- •- Patients who are unlikely to comply with the protocol (e.g.
- •uncooperative attitude, inability to return for subsequent visits) and/or
- •otherwise considered by the Investigator to be unlikely to complete the
- •Patients with regular administration of ASA, defined as >3 doses/week,
- •will be included in the observation group. Other additional regular use of
- •ASA must be withdrawn before randomization.
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