EUCTR2004-001860-27-GR进行中（未招募）不适用
A TREATMENT PROTOCOL FOR PATIENTS WITH GASTROINTESTINAL STROMAL TUMOR WHO ARE INELIGIBLE FOR PARTICIPATION IN OTHER SU011248 PROTOCOLS AND ARE REFRACTORY TO OR INTOLERANT OF IMATINIB MESYLATE
Pfizer Hellas A.E.0 个研究点目标入组 500 人开始时间: 2006年7月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
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. Histopathologically proven diagnosis of malignant GIST that is not amenable to
- •standard therapy with curative intent.
- •2. Must have undergone screening and found to be ineligible for participation in
- •ongoing SU011248 clinical studies such as the A6181004 Phase 3 trial.
- •3. Judged to have the potential to derive clinical benefit from SU011248 treatment
- •by the treating physician.
- •4. Failed prior treatment with imatinib mesylate, defined either by progression of
- •disease, or by significant toxicity during treatment with imatinib mesylate that
- •precluded further treatment. Intolerance to prior imatinib mesylate therapy will
- •be defined as follows:
- •- Life-threatening adverse events (ie, Grade 4 according to NCI CTCAE Version
- •3.0) at any dose (attempt to dose reduce or rechallenge not required) or
- •- Unacceptable toxicity induced by a moderate dose (eg, 400 mg/day).
- •Specifically, major/equal to Grade 2 toxicity that is unacceptable to the patient
- •(such as nausea) that persists despite standard countermeasures
- •5. Male or female, 18 years of age or older.
- •6. Resolution of all acute toxic effects of prior systemic therapy (including imatinib
- •mesylate), radiotherapy or surgical procedure to NCI CTCAE Version 3.0 grade
- •minor/equal to 1.
- •7. Adequate organ function as defined by the following criteria:
- •- Total serum bilirubin minor/equal to 2 x ULN (patients with Gilbert’s disease
- •- Serum transaminases <5 x ULN
- •- Absolute neutrophil count (ANC): major/equal to 1000/mL
- •- Platelets: major/equal75,000/mL
- •- Hemoglobin major/equal 8.0 g/dL
- •8. Signed and dated informed consent document indicating that the patient (or
- •legally acceptable representative) has been informed of all the pertinent aspects
- •of the trial prior to enrollment.
- •9. Willingness and ability to comply with scheduled visits, treatment plans and
- •laboratory tests and other study 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
- •Subjects presenting with any of the following will not be included in the trial:
- •1. Current treatment in another clinical trial
- •2. Symptomatic CNS metastases
- •3. Symptomatic congestive heart failure, myocardial infarction or coronary artery
- •bypass graft in the previous six months, ongoing severe or unstable angina or
- •any unstable arrhythmia requiring medication
- •4. Pregnancy or breastfeeding (see Section 4.4 for further details)
- •5. Other severe acute or chronic medical or psychiatric condition, or laboratory
- •abnormality that would impart, in the judgment of the investigator, excess risk
- •associated with study participation or study drug administration, or which, in the
- •judgment of the investigator, would make the patient inappropriate for entry into this study
研究者
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