EUCTR2018-004623-36-SE进行中（未招募）1 期
A MolEcularly Guided Anti-Cancer Drug Off-Label Trial – a multicenter, basket and umbrella explorative trial on the efficacy and safety of molecular profile selected commercially available targeted anti-cancer drugs in patients with advanced cancers progressive on standard therapy - MEGALiT
ppsala University Hospital0 个研究点目标入组 154 人开始时间: 2019年10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
- 154
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
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •1. Adult (age >18 years)
- •2. Patients with histologically-proven, locally advanced or metastatic solid tumor (part 1; hematological malignancies also eligible in part 2) progressive while on last line established therapy considered available for the patient. For re-recruitment (part 2, defined by section 7.8 of the protocol) patients must be progressive while on trial defined treatment or off-protocol treatment.
- •3. Fresh tumor sampling by biopsy must be possible, except for patients with CNS malignancy who can be included based on molecular analysis of archived tumor material.
- •4. ECOG performance status 0-2.
- •5. Patients must have acceptable organ function as defined below. However, specific inclusion/exclusion criteria specified in main protocol will take precedence:
- •a. Absolute neutrophil count = 1.5 x 10^9/L
- •b. Hemoglobin > 90 g/L
- •c. Platelets > 75 x 10^9/L
- •d. Total bilirubin < 2 x ULN
- •e. ASAT (SGOT) and ALAT (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
- •6. Patients must have objectively measurable disease (by physical or radiographic examination).
- •7. Ability to understand and the willingness to sign a written informed consent document.
- •8. For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome.
- •9. Negative pregnancy test in women of childbearing potential (premenopausal or <12 months of amenorrhea post-menopause and who have not undergone surgical sterilization). Women of childbearing potential must use highly effective method of contraception, i.e. combined hormonal contraception, or progestogen-only hormonal contraception, or intrauterine device, or intrauterine hormone-releasing system, or bilateral tubal occlusion, or vasectomized partner, or sexual abstinence for the duration of participation in the study, and four months following completion of study therapy.
- •10. Selected tumor types might have disease-specific inclusion criteria as defined by disease-specific study appendix (section 17.6 of the protocol).
- •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 this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •1. Ongoing treatment-related toxicity > grade 2.
- •2. Patients 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, somatostatin analogues and prednisone, or equivalent). These medications must have been started = 1 week prior to the screening visit on this study. Radiotherapy to non-target lesions is allowed.
- •3. Patients pregnant or nursing.
- •4. Patients of childbearing potential and sexually active and not willing to use highly effective contraceptive.
- •5. Patients with known active progressive CNS metastases. Patients with previously treated CNS 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 inclusion. All patients with previously treated CNS metastases must be stable for at least 1 month after completion of treatment and off steroid treatment prior to inclusion.
- •6. Some concomitant diseases qualified for exclusion as detailed in main protocol.
- •7. Other serious underlying medical conditions, which, in the Investigator’s judgment, could impair the ability of the patient to participate in the trial.
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