EUCTR2010-019683-37-IT进行中（未招募）1 期
PHASE II STUDY OF EVEROLIMUS IN PATIENTS WITH THYMOMA AND THYMIC CARCINOMA PREVIOUSLY TREATED WITH CHEMOTHERAPY - ND
ISTITUTO CLINICO HUMANITAS0 个研究点目标入组 51 人开始时间: 2011年2月8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
- 51
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.Signed and dated IRB/IEC-approved Informed Consent
- •2.Histological diagnosis of invasive recurrent or metastatic thymoma or thymic carcinoma confirmed by pathologist.
- •3.Patients must have had at least one prior platinum-containing chemotherapy regimen. There is no limit to the number of prior chemotherapy regimens received. Progressive disease should have been documented before entry into the study.
- •4.Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than 20 mm with conventional techniques or as greater than 10 mm with spiral CT scan.
- •5.Patients must have recovered from toxicity related to prior therapy to at least to grade 1 (defined by CTCAE 3.0).
- •6.Patients must not have had major surgery, radiation therapy, chemotherapy, biologic therapy (including any investigational agents), or hormonal therapy (other than replacement), within 4 weeks prior to entering the study.
- •7.Age ? 18 years.
- •8.Life expectancy ? 3 months.
- •9.Performance status (ECOG) ? 2.
- •10.Negative pregnancy test (if female in reproductive years)
- •11.Patients must have adequate organ and marrow function (as defined below). Patients must have returned to baseline or grade 1 from any acute toxicity related to prior therapy:
- •12.Leukocytes ?3,000/mm
- •13.Absolute neutrophil count ?1,500/mm
- •14.Hemoglobin ? 9 g/dL
- •15.Platelets ?100,000/mm
- •16.Total bilirubin ? 1.5 x institutional upper limit of normal (ULN)
- •17.AST(SGOT)/ALT(SGPT) ? 3 x institutional ULN (5x if LFT elevations due to liver metastases)
- •18.Creatinine 1?.5 xinstitutional ULN
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients with symptomatic brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. However, patients who have had treatment for their brain metastases and whose brain metastatic disease status has remained stable for at least 3 months without steroids may be enrolled at the discretion of the investigator.
- •2.Major surgery, other than diagnostic surgery, within 4 weeks prior to treatment
- •3.Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
- •4.Pregnant or breast feeding women
- •5.Previous (within the last 5 years) or current malignancies at other sites, except for adequately treated basal cell or squamous cell skin cancer or in situ carcinoma of the cervix uteri
- •6.Current enrollment in or participation in another therapeutic clinical trial within 4 weeks preceeding treatment start.
- •7.Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgement of the Investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
研究者
相似试验
招募中
Unknown
Clinical effects of everolimus in the subjects with autism spectrum disprders (ASD) in relation to tuberous sclerosis.there are a few individuals with TSC with SEGA who exhibite ASD symptoms.JPRN-jRCT1090220258Kunio Yui20
已完成
2 期
A phase 2 trial of EVERolimus alternating with SUNitinib as first line therapy for advanced renal cell carcinomaRenal Cell CarcinomaACTRN12609000643279The University of Sydney55
进行中（未招募）
1 期
/AAdvanced hormone - and chemotherapy - resistant prostate cancerEUCTR2011-002087-24-GRHellenic Oncology Research Group (HORG)
已完成
不适用
Therpeutic drug monitoring of Everolimus in patients with renal cell carcinoma and tuberous sclerosisJPRN-UMIN000011559Department of Urology, Keio University School of Medicine43
未知
2 期
Phase II clinical study of TY-0201 in patients with chronic heart failureChronic heart failureJPRN-jRCT2080222593TOA EIYO LTD.40