2023-509152-33-00招募中2 期
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: The Drug Rediscovery Protocol (DRUP trial)
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting36 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2024年3月26日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 36
- 主要终点
- Treatment-related grade≥3 and serious adverse events
研究概览
简要总结
- To describe the anti-tumor activity and toxicity of commercially available, targeted anti-cancer drugs used for treatment of patients with an advanced solid tumor, multiple myeloma, non-Hodgkin lymphoma or T-cell prolymphocytic leukemia that harbors 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 solid tumor, multiple myeloma, non-Hodgkin lymphoma or T-cell prolymphocytic leukemia that harbors a genomic or protein expression variant known to be a drug target or to predict sensitivity to a drug.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adult (age >18 years) patient with a histologically-proven locally advanced or metastatic solid tumor, multiple myeloma, non-Hodgkin lymphoma or T-cell prolymphocytic leukemia with symptomatic or radiological disease progression after standard anti-cancer treatment or for whom no such treatment is available or indicated. For patients with a primary brain tumor: Histologically confirmed recurrent or de novo primary brain tumor, with unequivocal progression after prior therapy, at least 3 months after radiotherapy (either first line chemo-radiotherapy or re-irradiation), and with stable or decreasing dosage of steroids for at least 7 days prior to the baseline MRI scan.
- •Because of the risks of drug treatment to the developing foetus, 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. Male patients, even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or completely abstain from sexual intercourse.
- •ECOG performance status 0-2
- •Patients must have acceptable organ function as defined below. However, specific inclusion/exclusion criteria specified in the drug-specific study manual 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
- •Patients must have objectively measurable disease (by physical or radiographic examination, according to RECIST v1.1 for patients with solid tumors, or according to IMWG, Lugano, RANO or GCIG criteria, resp., for patients with multiple myeloma, non-Hodgkin lymphoma, and T-cell prolymphocytic leukemia, primary brain tumors or ovarian cancer in case of CA125-based evaluation
- •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), immunohistochemistry (IHC) or RNA sequencing (RNAseq). The test may have been performed on the primary tumor or a metastatic deposit, in a diagnostic laboratory or within the context of another CPCT study, and must reveal a potentially actionable variant as defined in Section
- •The test results (full pathology or molecular diagnostics report) must be uploaded in the eCRF.
- •Patients must have a tumor profile for which treatment with one of the FDA and / or EMA approved (or under revision for approval) targeted anti-cancer drugs included in this study has potential clinical benefit based on preclinical data or clinical information
- •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. Alternatively, fresh frozen tumor tissue acquired in the context of a standard care procedure may be used, provided that no systemic anti-cancer treatment was given between the procedure and start of study treatment within DRUP. Exceptions are made for: a) patients with a primary brain tumor or other tumor types with only intracerebral lesions, only if the mandatory DRUP pre-treatment biopsy for biomarker analysis cannot safely be obtained; b) In case WGS is performed on tumor tissue outside the context of a clinical trial before inclusion, and without any type of anti-cancer therapy between the collection of tissue and inclusion in DRUP, this can replace the DRUP pre-treatment biopsy; c) patients that underwent an allogeneic hematopoietic stem cell transplantation prior to study enrollment, since this will prevent a correct WGS analysis due to a mismatch between the biopsy specimen and the required blood sample
- •Ability to understand and the willingness to sign a written informed consent document
- •For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
排除标准
- •Ongoing toxicity > grade 2, other than alopecia or grade 2 peripheral neuropathy.
- •Patient is receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement). Required wash out period prior to starting study treatment is at least two weeks. An exception is made for patients suffering from CRPC are allowed to continue androgen deprivation therapy
- •Patient is pregnant or nursing
- •Patients with 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. Specific exclusion criteria for patients with primary brain tumors: 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.
- •Patients with clinically significant preexisting cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure
- •Patients with known left ventricular ejection fraction (LVEF) < 40%
- •Patients with stroke (including TIA) or acute myocardial infarction within 3 months before the first dose of study treatment
- •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
结局指标
主要结局
Treatment-related grade≥3 and serious adverse events
Treatment-related grade≥3 and serious adverse events
Disease control, defined as Stable Disease (SD) at 16 weeks after treatment initiation
Disease control, defined as Stable Disease (SD) at 16 weeks after treatment initiation
Percentage of patients that are treated based on their molecular tumor profile
Percentage of patients that are treated based on their molecular tumor profile
Objective tumor response
Objective tumor response
次要结局
- Progression-free and overall survival
- Duration of treatment on study (time on drug)
研究者
Prof. dr. E.E. Voest
Scientific
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
研究点 (36)
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