EUCTR2021-002632-23-IT进行中（未招募）1 期
A proof-of-concept, biomarker-driven, phase-II clinical trial to explore the activity of decitabine repurposing against advanced, refractory, KRAS-dependent pancreatic ductal adenocarcinoma (PDAC): The ORIENTATE (tailOred dRug repurposIng of dEcitabine in KRAS-dependeNt refracTory pAncreaTic cancEr) trial. - ORIENTATE
ISTITUTI FISIOTERAPICI OSPITALIERI0 个研究点目标入组 17 人开始时间: 2021年9月7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
- 17
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
- •1.Age = 18 years;
- •2.Histologically or cytologically proven, advanced, inoperable (metastatic or locally advanced), PDAC;
- •3.Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2;
- •4.Life expectancy of at least 12 weeks;
- •5.At least one and no more than two lines of systemic treatment for advanced disease;
- •6.At least one metastatic lesion(s) and/or primary tumor amenable to pre-treatment biopsy;
- •7.KRAS dependency, as assessed by molecular analysis of RNA isolated from a fresh tumor biopsy;
- •8.Imaging-documented progressive disease (PD), according to modified RECIST 1.1 criteria;
- •9.Imaging-documented measurable disease, according to modified RECIST 1.1 criteria;
- •10.Adequate organ and marrow function;
- •11.Postmenopausal status or evidence of non-childbearing status (negative urine or serum pregnancy test) for women of childbearing potential;
- •12.Women of childbearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization) and fertile men must agree to use two highly effective forms of contraception while they are receiving study treatment and for 3 months after last dose of study drug. Male subjects must agree to refrain from sperm donation during the study and for 30 days after the last dose of study drugs;
- •13.Ability to understand and willingness to sign an appropriate written informed consent form (ICF). Signed informed consent form must be obtained prior to initiation of study-related activities.
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •Exclusion criteria
- •1.Uncontrolled intercurrent illness(es);
- •2.Pregnancy or lactation;
- •3.Active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy;
- •4.Major surgical intervention within 4 weeks prior to enrollment;
- •5.Radiotherapy, surgery, chemotherapy, or an investigational therapy within 2 weeks prior to signing the treatment ICF;
- •6.Any previous treatment with DEC;
- •7.Patients with second primary cancers, except for adequately treated non- melanoma skin cancer, curatively treated in-situ cancer of the cervix, stage 1 grade 1 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) treated with curative intent and with no evidence of active disease at >1 year from the completion of curative treatment prior to study entry;
- •8.Persistent toxicities (=CTCAE grade 2) caused by previous cancer therapy, excluding alopecia;
- •9.Serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug;
- •10.Serious psychiatric or medical conditions that could interfere with a valid informed consent.
研究者
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