CTIS2023-510092-62-00招募中1 期
An open-label single arm interventional phase 2 study to investigate outcome of individualized treatment based on pharmacogenomic profiling and ex vivo drug sensitivity testing of patient-derived organoids in patients with metastatic colorectal cancer - 2020-01-v2
Oslo University Hospital HF0 个研究点目标入组 45 人开始时间: 2024年4月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 45
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Pre-screeining: Has a histologically-proven locally advanced or metastatic adenocarcinoma from colon or rectum, Main study: Has measurable or evaluable disease (per RECIST v1.1), main Study: ECOG performance status 0 or 1, Main study: For orally administered drugs, the participant must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome., Main study: Because of the risks of drug treatment to a developing fetus, women of child-bearing potential and men must agree to use adequate contraception in accordance with the respective SmPC, Main study: Has acceptable organ function as defined below. However, as noted below (exclusion criteriom 16), drug-specific inclusion/exclusion criteria specified in the Appendix 16/respective SmPC for each agent will take precedence for this and all inclusion criteria:, Pre-screening: Has received or is receiving systemic treatment for mCRC, Pre-screening: Has non-resectable metastases and eligible to undergo a radiological-guided core biopsy from at least one metastasis, Pre-screening: ECOG performance status 0 or 1, Pre-screening: Has measurable or evaluable disease (per RECIST v1.1), Pre-screening: Is capable of giving signed informed consent, as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, Main studiy: Has a histologically-proven locally advanced or metastatic adenocarcinoma from colon or rectum (mCRC), Main studiy: Has received at least two lines of SOC chemotherapy for mCRC, Main study: Has full combined pharmacogenomic profile (genomic and transcriptomic profile of the patients tumor and ex vivo drug sensitivity testing of PDOs from the patient’s own tumors cells) from which the MTB suggests a treatment with one of the defined targeted anti-cancer therapies provided this study
排除标准
- •Pree-screening: Has other clinically significant medical conditions which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements., Main study: Has had a stroke (including TIA) or an acute myocardial infarction within 6 months before the first dose of study treatment., Main study: Has had acute gastrointestinal bleeding within 1 month of start of treatment, Main study: Has other clinically significant medical conditions which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements., Main study: Meets any of the assigned drug contraindications or other drug-specific exclusion criteria as described in the respective SmPC and in Appendix 16, Main study: Has ongoing toxicity > CTCAE grade 2, other than peripheral neuropathy and alopecia, related to anti-tumor treatment that was completed within 4 weeks prior to registration. Patients with ongoing peripheral neuropathy of = CTCAE grade 3 will be excluded., Main Study: Has received previous treatment with the selected study drug for the same malignancy, Main study: Has a tumor with a genomic variant known to confer resistance to an anti-cancer agent available in this study, the patient will not be eligible to receive that agent but will be eligible to receive other drugs available in this study if all inclusion and exclusion criteria are met for that drug., Main study: Is receiving any other anti-cancer therapies (cytotoxic, biologic, radiation, or hormonal other than for replacement). Participants may be on warfarin, low molecular weight heparin or direct factor Xa inhibitors, unless such therapies are prohibited by drugspecific exclusion criteria (please consult the corresponding SmPC and Appendix 16 for prohibited medication and contraindication/precautions)., Main study: Is pregnant or breastfeeding or refusing any type of required contraception methods., Main study: Has known CNS metastases., Main study: Has preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure., Main study: Has left ventricular ejection fraction (LVEF) known to be < 40%.
研究者
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