2023-507894-16-00招募中2 期
Improving public cancer care by implementing precision medicine in Norway A multi-cohort phase 2 treatment clinical study investigating efficacy of approved drugs outside indication in patients with advanced cancer. IMPRESS-Norway
Oslo University Hospital HF18 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年8月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 18
- 主要终点
- Percentage of patients that are included and treated based on their molecular tumour profile;
研究概览
简要总结
To describe the anti-tumour activity and toxicity of commercially available, targeted anti-cancer drugs used for treatment of patients with advanced malignancy that harbours a genomic- or protein expression variant known to be a drug target or to predict sensitivity to a drug.
To facilitate patient access to commercially available, targeted anti-cancer drugs of potential efficacy for treatment of an advanced malignancy that harbours a genomic or protein expression variant known to be a drug target or to predict sensitivity to a drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •ECOG performance status 0-2
- •Life expectancy minimum 3 months
- •Patient with a pathology-proven locally advanced or metastatic malignant disease who is no longer benefitting from standard anti-cancer treatment or for whom, in the opinion of the investigator, no such treatment is available or indicated.
- •Patients must have acceptable organ function as defined below (exceptions for haematological diagnoses): a) Absolute neutrophil count ≥ 1.5 x109 / L b) Hemoglobin > 9 g/dl c) Platelets > 75,000/µl d) Total bilirubin < 1.5 x institutional upper limit of normal (ULN) e) AST (SGOT) and ALT(SGPT) < 2.5 x institutional upper limit of normal (ULN) (or < 5 x ULN in patients with known hepatic metastases) f) Calculated or measured creatinine clearance ≥ 40 mL/min/1.73 m2
- •For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
- •Results must be available from a genomic / molecular test performed in a preapproved laboratory (Section 10.1). The test used to qualify a patient for participation in IMPRESS-Norway may have been performed on any specimen of the patient’s tumour obtained at any point during the patient’s care at the discretion of the patient’s treating physician. Genomic assays performed on cell-free DNA in plasma (“liquid biopsies”) will also be acceptable if the genomic analysis is performed as defined in Section 10.
- •NGS analyses will be performed on a newly sampled biopsy if possible. Information from these analyses might be used upon progression, for evaluation of possible new cohort-inclusion.
- •Have a genomic profile for which treatment with one of the approved targeted anti-cancer therapies included in this study has potential clinical benefit
排除标准
- •Patients eligible to enter other ongoing trials which have the potential to benefit the patients equally or more than a IMPRESS-Norway cohort, and for
- •Ongoing toxicity > CTCAE grade 2, other than peripheral neuropathy, related to anti-tumour treatment that was completed within 4 weeks prior to treatment initiation. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3.Patients with known allergy/hypersensitivity to the study drug (active substance or to any of the excipients).
- •Patients with acute gastrointestinal bleeding within 1 month of start of treatment
- •Patients with stroke (including TIA) or acute myocardial infarction within 4 months before the first dose of study treatment
结局指标
主要结局
Percentage of patients that are included and treated based on their molecular tumour profile;
Percentage of patients that are included and treated based on their molecular tumour profile;
Treatment-related grade ≥3 and serious adverse events
Treatment-related grade ≥3 and serious adverse events
次要结局
- Progression-free and overall survival
- Duration of time on drug
研究者
Åslaug Helland
Scientific
Oslo University Hospital HF
研究点 (18)
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