EUCTR2004-001860-27-GB进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
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
入选标准
- •1. Histopathologically proven diagnosis of malignant GIST that is not amenable to
- •standard therapy with curative intent.
- •2. Must be ineligible for participation in ongoing SU011248 clinical studies ( if any Phase 1, 2 or 3 SU011248 protocols for patients having GIST are open to enrollment at the institution).
- •If there are no SU0011248 protocols open at the institution, patients may be entered if meeting the study entry criteria.
- •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. Administration of the last dose of imatinib mesylate =1 - week prior to start of treatment.
- •6. Male or female, 18 years of age or older.
- •7. 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.
- •8. 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
- •9. 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.
- •10. 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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