EUCTR2005-004837-16-DE进行中（未招募）不适用
Multicenter, single-arm, two-stage phase II trial of RAD001 (everolismus) with Glivec® in Glivec®-resistant patients with progressive GIST
ovartis Pharma GmbH0 个研究点目标入组 53 人开始时间: 2006年9月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 53
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 >= 18 years
- •2.Histologically proven diagnosis of GIST
- •3.Objectively documented evidence of progressive disease according to the RECIST criteria despite at least 2 months' continuous treatment with Glivec® at a dosage of 400 mg/day. A treatment period of 2 weeks before study entry with an increased dosage of Glivec due to progression is allowed.
- •4.Clinical evidence of resistance to Glivec® on treatment with 400 mg/day Glivec®
- •5.Progression must be documented on CT or MRI scans. The scans on which progression is documented should be at maximum 2 weeks old. New scans are only required as baseline scans if they are older then approx. 2 weeks
- •6.At least one measurable lesion (longest diameter >= 20 mm on conventional CT or MRI scan; >= 10 mm on spiral CT)
- •7.ECOG Performance Status 0-2
- •8.Adequate bone marrow, liver and renal function on Glivec® treatment
- •9.Patients must be at least 4 weeks since prior major surgery and recovered, at least 2 weeks since prior minor surgery and recovered
- •10.Written informed consent must be obtained prior to any screening procedures
- •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.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 must have a negative serum pregnancy test <= 48 hours prior to the administration of study medication
- •2.Patients presenting with known or symptomatic CNS metastases or leptomeningeal involvement
- •3.Use of other investigational cancer therapies within 28 days prior to enrollment or which are currently being or planned to be received during the course of the study
- •4.Patients who previously received rapamycin in combination with Glivec®
- •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 infections including abscess or fistulae, etc.)
- •6.Patients with a history of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or in-situ cervical cancer
- •7.Patients receiving glucocorticoids (only if the p70s6 kinase-1 assay is being performed), since glucocorticoids have been shown to inhibit p70s6 kinase-1 activity
- •8.Patients unwilling to or unable to comply with the protocol
研究者
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