EUCTR2015-004398-33-NL进行中（未招募）1 期
The Drug Rediscovery Protocol (DRUP trial) A Dutch National Study on behalf of the Center for Personalized Cancer Treatment (CPCT) to Facilitate Patient Access to Commercially Available, Targeted Anti-cancer Drugs to determine the Potential Efficacy in Treatment of Advanced Cancers with a Known Molecular Profile - DRUP
etherlands Cancer Institute0 个研究点目标入组 950 人开始时间: 2015年12月2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
- 950
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
入选标准
- •1. Adult (age >18 years) patient with a histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma who is no longer benefitting from standard anti-cancer treatment or for whom no such treatment is available or indicated.
- •2. ECOG performance status 0-2
- •3. Patients must have acceptable organ function as defined below. However, specific inclusion/exclusion criteria specified in the appendix for each agent will take precedence:
- •a. Absolute neutrophil count = 1.5 x 109/l
- •b. Hemoglobin > 5.6 mmol/l
- •c. Platelets > 75 x 109/l
- •d. Total bilirubin < 2 x ULN
- •e. AST (SGOT) and ALT (SGPT) < 2.5 x institutional ULN (or < 5 x ULN in patients with known hepatic metastases)
- •f. Serum creatinine = 1.5 × ULN or calculated or measured creatinine clearance = 50 mL/min/1.73 m2
- •4. Patients must have objectively evaluable or measurable disease (by physical or radiographic examination, according to RECIST v1.1 for patients with solid tumors and / or GCIG criteria in case of CA125-based evaluation for ovarian cancer, or according to IMWG, Lugano or RANO criteria, resp., for patients with multiple myeloma, non-Hodgkin lymphoma, glioblastoma.
- •5. Results must be available from a tumor genomic or protein expression test. Eligible tests may include any of the following technologies: fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), comparative genomic hybridization (CGH), next generation sequencing (NGS) or immunohistochemistry (IHC). The test may have been performed on the primary tumor or a metastatic deposit, or on a new fresh frozen tumor biopsy specimen (see inclusion criterion 7), and must reveal a potentially actionable variant as defined in the study protocol.
- •6. Have a tumor molecular profile for which treatment with one of the EMA approved targeted anti-cancer drugs included in this study has potential clinical benefit based on preclinical data or clinical information (see section 5).
- •7. A new (obtained =2 months before inclusion, and without any type of anti-cancer therapy within those =2 months ) fresh frozen tumor biopsy specimen for extensive biomarker testing is mandatory before the start of treatment with a targeted agent included in the protocol.
- •8. Ability to understand and the willingness to sign a written informed consent document.
- •9. For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
- •10. Because of the risks of drug treatment to the developing fetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for four months following completion of study therapy. Male patients should avoid impregnating a female partner.
- •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 thi
排除标准
- •1. Ongoing toxicity > grade 2, other than alopecia.
- •2. Patient is receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g., megestrol acetate, bisphosphonates). These medications must have been started = 1 week prior to enrollment on this study.
- •3. Patient is pregnant or nursing.
- •4. Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the 3 months prior to registration. All patients with previously treated brain metastases must be stable for at least 1 month after completion of treatment and off steroid treatment prior to study enrollment.
- •Additional exclusion criteria specific for glioblastoma patients:
- •a. Patients who require anti-convulsant therapy must be taking non-enzyme inducing antiepileptic drugs (non-EIAED). EIAED are prohibited. Patients previously on EIAED must be switched to non-EIAED at least 2 weeks prior to randomization.
- •b. No radiotherapy within the three months prior to the diagnosis of progression.
- •c. No radiotherapy with a dose over 65 Gy, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven.
- •5. Patients with clinically relevant preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure are not eligible.
- •6. Patients with known left ventricular ejection fraction (LVEF) < 40% are not eligible
- •7. Patients with stroke (including TIA) or acute myocardial infarction within 2 months before the first dose of study treatment are not eligible
- •8. Patients with any other clinically significant medical condition 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 including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness/social situations.
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