EUCTR2004-002231-92-BE进行中（未招募）1 期
A Phase II Study of AP23573, an mTOR Inhibitor, in Patients with Advanced Sarcoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 176
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.Patients =15 years of age with metastatic and/or unresectable sarcomas of the following histological subgroups:
- •·Bone sarcomas, such as osteosarcoma and Ewings sarcoma
- •·Leiomyosarcoma
- •·Liposarcomas*
- •·Any other soft tissue sarcoma* except GIST
- •* Patients with well-differentiated liposarcoma or desmoid tumors must have demonstrated progressive disease within the previous 6 months.
- •2.Presence of at least one measurable lesion that:
- •·Can be accurately measured in at least one dimension with longest diameter =20 mm using conventional techniques or =10 mm with spiral CT scan (or otherwise at least twice the reconstruction interval for CT or MRI scans).
- •·Previously irradiated lesions may be considered to be measurable provided: 1) there has been documented progression of the lesion(s) since completion of radiotherapy, and 2) the criteria for measurability as outlined above are met.
- •3.ECOG performance status =1
- •4.Minimum life expectancy of 3 months
- •5.Adequate renal and hepatic function, defined as:
- •·Total serum bilirubin = 1.5 x ULN for the institution
- •·AST and/or ALT = 3 x ULN for the institution (= 5 x ULN if liver metastases are present)
- •·Serum albumin = 2.5 g/dL
- •·Serum Creatinine =1.5 x ULN for the institution (or a calculated creatinine clearance = 50 mL/min/1.73m2)
- •6.Adequate bone marrow function, defined as:
- •·ANC = 1.5 x 10^9/L
- •·Platelet count = 100 x 10^9/L
- •7.Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL
- •8.Male and female patients who are not surgically sterile or postmenopausal must agree to use reliable methods of birth control for the duration of the study until 30 days after the last dose of study drug
- •9.Able to understand and give written informed consent
- •Are the trial subjects under 18? yes
- •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.Women who are pregnant or lactating
- •2.Presence of brain metastases
- •3.Prior therapy with rapamycin, rapamycin analogues or tacrolimus
- •4.Prior anticancer treatment (chemotherapy, radiotherapy, hormonal, immunotherapy, biologoical response modifiers, signal transduction inhibitors, etc) within 4 weeks prior to the first dose of AP23573; the interval is = 2 weeks for signal transduction inhibitors with a half-life known to be <24 hours, and is = 6 weeks for nitrosourea or mitomycin. The following exceptions are allowed:
- •·hormonal therapy (e.g., Megace) for appetite stimulation
- •·nasal, ophthalmic, and topical glucocorticoid preparations
- •·a stable dose of corticosteroids for at least two weeks
- •·low dose maintenance steroid therapy for other conditions
- •·physiologic hormone replacement therapy (e.g., thyroid supplementation for thyroid deficiency or oral replacement glucocorticoid therapy for adrenal insufficiency)
- •5.Ongoing toxicity associated with prior anticancer therapy (except peripheral neuropathy of = grade 1 by NCI toxicity criteria)
- •6.Another primary malignancy within the past three years (except for non-melanoma skin cancer and cervical carcinoma in situ)
- •7.Known or suspected hypersensitivity to drugs formulated with polysorbate 80 (Tween) or any other excipient contained in the study drug
- •8.Known Grade 3 or 4 hypersensitivity to macrolide antibiotics (e.g., clarithromycin, erythromycin, azithromycin)
- •9.Significant uncontrolled cardiovascular disease
- •10.Active infection requiring systemic therapy
- •11.Known HIV infection
- •12.Treatment with any investigational agent within 4 weeks prior to the first dose of AP23573
- •13.Concurrent treatment with immunosuppressive agents other than prescribed corticosteroids at stable doses for = 2 weeks prior to first planned dose of study drug
- •14.Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to the first dose of AP23573
- •·Patients having undergone recent placement of a central venous access port will be considered eligible if they have recovered
- •15.Presence of any other life-threatening illness or organ system dysfunction which, in the opinion of the Investigator, would either compromise the patient’s safety or interfere with evaluating the safety of the study drug
研究者
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