EUCTR2007-005294-60-DE进行中（未招募）1 期
Multicenter, triple-arm, single-stage, phase II trialto determine the preliminary efficacy and safety of RAD001in patients with histological evidence of progressive or metastaticbone or soft tissue sarcomas
ovartis Pharma GmbH0 个研究点目标入组 60 人开始时间: 2008年1月21日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •Histological evidence of progressive or metastatic bone or soft tissue sarcoma.
- •The following tumor types are included:
- •? alveolar soft part sarcoma (ASPS)
- •?malignant fibrous histiocytoma;
- •?liposarcoma;
- •?synovial sarcoma;
- •?malignant paraganglioma;
- •?fibrosarcoma;
- •?leiomyosarcoma;
- •?angiosarcoma including haemangiopericytoma;
- •?malignant peripheral nerve sheath tumor;
- •?STS, not otherwise specified;
- •?miscellaneous sarcoma including mixed mesodermal tumors of the uterus;
- •?osteosarcoma;
- •?Ewing’s sarcoma;
- •?rhabdomyosarcoma;
- •?gastrointestinal stromal tumor (only after failure or intolerance of imatinib or sunitinib in 1st and 2nd line).
- •Objective progression of disease may be documented by RECIST criteria. Any of the following would be sufficient according to RECIST:
- •?a 20% increase in the sum of unidimensionally measured target lesions;
- •?a new lesion;
- •?unequivocal increase in non-measurable disease.
- •At baseline, a CT or MRI scan must demonstrate measurable disease by RECIST criteria, i.e. the presence of at least one measurable lesion. Measurable disease lesions must be accurately measured in at least one dimension with longest diameter ? 20mm using conventional techniques or ? 10mm with spiral CT scan (with minimum lesion size no less than double the slice thickness). (see post-text supplement 1).
- •At least one measurable lesion outside of the field of any prior radiation therapy (according to RECIST criteria). Prior radiotherapy to a single index lesion is not allowed.
- •Adult male or female patients (=18 years of age). In countries outside Germany patients at the age of = 16 can also be included into the trial.
- •Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent.
- •Adequate bone marrow function as shown by: absolute neutrophil count (ANC) > 1,500/µl, Platelets = 100,000/µl, Hb > 9g/dL.
- •Adequate renal function as shown by: a serum creatinine value < 1.5 x upper limit of normal (ULN).
- •Adequate liver function as shown by:
- •serum bilirubin = 1.5 x ULN;
- •INR < 1.3 x ULN (or < 3 on anticoagulants);
- •ALT and AST = 2.5x ULN (= 5x ULN in patients with liver metastases).
- •ECOG performance status 0 – 2.
- •Fully recovered from any previous surgery, prior chemotherapy or radiation therapy (at least 4 weeks since major surgery or prior myelosuppressive chemotherapy). Prior radiotherapy to a single index lesion is not allowed. With the exception of alopecia, patients must have resolution of all acute toxic effects of any prior surgery, radiotherapy, or chemotherapy to NCI CTC (Version 3.0) grade = 1.
- •Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks by the investigator (or his/her designee) with the aid of written information.
- •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
- •Anticancer therapy within 3 weeks of enrollment including chemotherapy, hormonal therapy, immunotherapy, or radiotherapy.
- •The following tumor types will not be included:
- •?gastrointestinal stromal tumor (except for patients after treatment with imatinib or sunitinib in 1st and 2nd line);
- •?chondrosarcoma;
- •?malignant mesothelioma;
- •?neuroblastoma.
- •Prior therapy with RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus).
- •neurotoxicity = grade 2 CTC.
- •Radiation of the lung.
- •Patients taking drugs known to inhibit or induce isoenzyme CYP3A (Table 6-4) are excluded unless the drugs are medically necessary and no substitutes are available. If there are no acceptable substitutes, special precautions should be taken in these patients (section 6.3.5).
- •Patients with any concurrent major medical condition liable to compromise the patient's participation in the study (e.g. known HIV infection, uncontrolled diabetes, serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure, myocardial infarction within 6 months, unstable angina, chronic or acute renal or liver disease, uncontrolled serious infections including abscess or fistulae, etc.).
- •Patients with a history of another malignancy prior to study entry, except curatively treated non-melanotic skin cancer or carcinoma in-situ cervical cancer unless in complete remission or no evidence of disease and off all therapy for that disease for a minimum of 5 years.
- •No symptomatic brain metastasis. Patients with asymptomatic brain metastases can be entered, if this is deemed to be in the best interest of the patient by the responsible physician. Previously radiated brain lesions will be defined non evaluable for response.
- •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- •History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures.
- •Patients committed to an institution by order of the authorities or court decision.
- •Female patients who are pregnant or breast feeding or patients of reproductive potential not employing an effective method of birth control. Because oral, implantable or injectable contraceptives may be affected by cytochrome P450 interactions, an appropriate method of birth control should be used throughout the trial in both sexes. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 48 hours prior to the administration of study medication.
- •Definition of women of child-bearing potential (WOCBP): all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: Acceptable methods of contraception may include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensures compliance. Appropriate contraception is defined as surgical sterilization (e.g. bilateral tubal lig
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