NL-OMON54670招募中2 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
ederlands Kanker Instituut0 个研究点目标入组 1,550 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •INCLUSION CRITERIA:
- •1. Adult (age >18 years) patient with a histologically-proven locally advanced
- •or metastatic solid tumor, multiple myeloma or non-Hodgkin lymphoma with
- •symptomatic disease progression or progression according to RECIST-criteria
- •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.
- •2. ECOG performance status 0-2
- •3. 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
- •4. Patients must have objectively evaluable or 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, glioblastoma or ovarian
- •cancer in case of CA125-based evaluation (please refer to appendices for
- •further details) [15, 16].
- •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, in a diagnostic laboratory or within the context of another CPCT
- •study, and must reveal a potentially actionable variant as defined in Section
- •5. The test results (full pathology or molecular diagnostics report) must be
- •uploaded in the eCRF.
- •6. 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 (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. 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.
- 另有 4 项未显示
排除标准
- •EXCLUSION CRITERIA:
- •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). Required wash out period
- •prior to starting study treatment is at least two weeks. An exception is made
- •Patients suffering from CRPC are allowed to continue androgen deprivation
- •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 GBM 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 significant preexisting cardiac conditions,
- •including uncontrolled or symptomatic angina, uncontrolled atrial or
- •ventricular arrhythmias, or symptomatic congestive heart failure are not
- •6. Patients with known left ventricular ejection fraction (LVEF) < 40% are not
- •7. Patients with stroke (including TIA) or acute myocardial infarction within 3
- •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.
- •For each drug included in this protocol, specific inclusion and exclusion
- •criteria (based on the Package Insert or manufacturers recommendations) may
- •also apply. These can be found in the supplemental information about each agent
- •included in the drug-specific study manuals. Drug-specific inclusion and
- •exclusion criteria will take precedence over the inclusion/exclusion criteria
- •listed above.
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