EUCTR2014-002876-10-IT进行中（未招募）不适用
A PHASE II STUDY OF THE COMBINATION OF GEMCITABINE AND IMATINIB MESYLATE IN PEMETREXED-PRETREATED PATIENTS WITH MALIGNANT PLEURAL MESOTHELIOMA
Istituto Clinico Humanitas0 个研究点开始时间: 2014年9月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- 性别
- All
入选标准
- •1) Age of > 18 years.
- •2) Patients with a histologically proven malignant
- •mesothelioma of the pleura, expressing PDFGR-beta
- •and/or C-Kit by immunochemistry (ICH).
- •3) Locally advanced disease, unsuitable for curative surgical
- •resection, or metastatic disease.
- •4) Confirmed progression of the disease according to
- •modified RECIST-criteria, documented after a
- •pemetrexed-based chemotherapy.
- •5) ECOG Performance Status of 0, 1 or 2.
- •6) Life expectancy of at least 3 months.
- •7) Written informed consent.
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Co-existing tumors of different histologic origin, except
- •non melanomatous localized skin cancer and/or in situ
- •cervical carcinoma.
- •2) A history of earlier tumors of different histologic origin
- •being in complete remission since less than 5 years.
- •3) Unresolved toxicity from prior antitumor treatment(s).
- •4) Primary peritoneal mesothelioma.
- •5) Any of the following abnormal baseline hematological
- •a. Hb < 9 g/dL
- •b. WBC < 3 x 10^9/L
- •c. Neutrophils < 1.5 x 10^9/L
- •d. Platelets < 100 x 10^9/L
- •e. Serum bilirubin > 2.5 mg/dL
- •f. ALAT and ASAT > 3 x UNL (unless due to liver
- •metastases)
- •g. Serum creatinine > 1.5 mg/dL.
- •6) Symptomatic and/or unstable pre-existing brain
- •metastases. To be enrolled in the study, subjects must
- •have confirmation of stable disease by MRI or computer tomography (CT) scan within 4 weeks from day 1 of cycle 1 of treatment and have CNS metastases well controlled by steroids, anti – epileptics or other symtom-relieving medications.
- •7)Clinically relevant cardiovascular disease, i.e., myocardial infarction or other severe coronary artery diseases within the prior 6 months, cardiac arrythmia requiring medication, uncontrolled hypertension, overt cardiac failure or non compensated chronic heart disease in NYHA class II or more.
- •8)History of psychiatric disabilities, potentially interfering with the capability of giving adequate informed consent.
- •9)Pregnant or lactating women or inability/unwillingness to practice a medically approved method of contraception during study period (including 3 months following the end of treatment)
- •10)Uncontrolled active infections.
- •11)Any condition which, in the judgement of the Investigator, would place the patient at undue risk or interfere with the results of the study.
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