EUCTR2006-002267-11-BE进行中（未招募）1 期
A randomized, open-label,multi-center study to evaluate the efficacy of nilotinib versus imatinib in adult patients with gastrointestinal stromal tumors resistant to imatinib and resistant/intolerant to sunitinib - A2201
ovartis Pharma Services0 个研究点目标入组 237 人开始时间: 2007年3月19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
- 237
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
- •Age : older than 18 years at Visit 1
- •Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic
- •and therefore not amenable to surgery or combined modality with curative intent
- •prior to or at Visit 1
- •Radiological (CT/MRI) confirmation of disease progression (RECIST criteria) during imatinib therapy at dose of at least 400 mg daily and radiological confirmation of disease progression (RECIST criteria) during sunitinib therapy that was started at 50 mg daily dose (even if progression of disease occurred at a reduced dose) OR documented intorlerance (defined above in population) to imatinib and/or sunitinib.
- •At least one measurable site of disease on CT/MRI scan at Visit 1, as defined by
- •RECISTcriteria (see Post Text Suppl 3 for details)
- •WHO Performance Status of 0, 1 or 2 at Visit 1 and 2
- •Patients must have normal organ, electrolyte, and marrow function at Visit 1 and
- •Ability to understand and willingness to sign a written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Prior treatment with nilotinib or any other tyrosine kinase inhibitors or targeted agents with exception of imatinib and sunitinib.
- •Treatment with any cytotoxic and/or investigational cytotoxic drug = 4 weeks (6
- •weeks for nitrosurea or mitomycin C) prior to Visit 1 with the exception of imatinib
- •and sunitinib targeted therapy
- •Prior or concomitant malignancies (primary tumor or a relapse diagnosed and treated in the last 5 years) other than GIST with the exception of previous or concomitant basal cell skin cancer or previous cervical carcinoma in situ
- •Impaired cardiac function at Visit 1or 2
- •Use of therapeutic coumarin derivatives
- •Patients who are currently receiving treatment with medications that have the
- •potential to prolong the QT interval
- •Patients who have undergone major surgery = 2 weeks prior to Visit 1 or who
- •have not recovered from side effects of such therapy
- •Patients who have received wide field radiotherapy = 4 weeks or limited field
- •radiation for palliation < 2 weeks prior to Visit 1 or who have not recovered from
- •side effects of such therapy
- •Women who are pregnant, breast feeding or adults of reproductive potential not employing an effective method of birth control. Post menopausal women must be amenorrheic for at least 12 months to be considered of nonchildbearing potential. Male and female patients must agree to employ an effective method of contraception during the study and for up to three months following discontinuation from the study. Effective methods of contraception are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly.
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