CTRI/2009/091/000506已完成2 期
A multi-center, single arm, Phase II study of adjuvant imatinib mesylate (glivec®) in patients following the resection of primary gastrointestinal stromal tumor (GIST)
Novartis India Ltd4 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2009年8月9日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- To assess Recurrence Free Survival Rate in patients with resected primary GIST who aretreated with adjuvant imatinib for a duration of 2 years
研究概览
简要总结
Number patients proposed to be recruited from India is 10. Tentative date of enrollment will in August.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
入选标准
- •Histologically proven diagnosis of primary GIST (without peritoneal or distant metastasis) with positive immunostaining for KIT (CD117);
- •Undergone complete gross resection of a primary GIST within 70 days prior to enrollment (includes R0 (negative microscopic margins) and R1 (positive microscopic margins);
- •Intermediate and high risk patients based on Corless criteria
- •Patient must be 18 years of age or older
- •Patient must have a post-operative CT scan with IV and PO contrast or MRI (optional) with contrast (if allergic to CT contrast) of abdomen and pelvis within 28 days prior to registration.
- •Patient must have the following post-operative laboratory values confirmed within 14 days prior to registration:a.
- •Creatinine ≤ 1.5 times the institution ULN (upper limit of normal)b.WBC ≥ 2,000/mm3c.Platelets ≥ 100,000/mm3d.Total Bilirubin ≤ 1.5 times the institution ULN.
- •NOTE:Patients with elevated bilirubin secondary to Gilbert?s disease are eligible to participate in the study.e.AST ≤ 2.5 times the institution ULNf.ALT ≤ 2.5 times the institution ULNg.Female of childbearing potential must have negative serum pregnancy test.NOTE:Post-menopausal women must be amenorrheic for at least 12 months to be deemed not of reproductive potential.
- •Patient or the patient?s legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.
- •Patient must provide written authorization to allow the use and disclosure of their protected health information.
- •NOTE: This may be obtained in either the study-specific informed consent or in a separate authorization form and must be obtained from the patient prior to study registration (non-US sites are exempt from HIPAA regulations).
- •If patient is a cancer survivor, ALL of the following criteria apply:a.Patient has undergone potentially curative therapy for all prior malignancies.b.No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone).c.
- •Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
排除标准
- •Patient has received post-operative chemotherapy.
- •Patient has received post-operative radiation therapy.
- •Patient has received post-operative investigational treatment.
- •Patient has received prior therapy with imatinib, or any other molecular targeted or biological therapy.
- •Patient has had an active infection requiring antibiotics within 14 days prior to registration.
- •Patient has objective evidence of residual disease on the postoperative CT scan or MRI (optional) of the abdomen or pelvis.
- •Patient, if female and breastfeeding.
- •NOTE: It is not known whether imatinib or its metabolites are excreted in human milk.
- •However, in lactating female rats administered 100mg/kg, a dose approximately equal to the maximum clinical dose of 800mg/day based on body surface area, imatinib and /or its metabolites were extensively excreted in milk.
- •It is estimated that approximately 1.5% of a maternal dose is excreted into milk, which is equivalent to a dose to the infant of 30% the maternal dose per unit body weight.
- •Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants, women should be advised against breastfeeding while taking imatinib.
- •Patient has New York Heart Association Class 3 or 4 cardiac disease (Appendix 3)
- •Patient is taking full dose warfarin.
- •NOTE: The use of mini-dose warfarin (1 mg orally per day) for prevention of central line-associated deep venous thrombosis is permitted.10.
结局指标
主要结局
To assess Recurrence Free Survival Rate in patients with resected primary GIST who aretreated with adjuvant imatinib for a duration of 2 years
时间窗: 2 Years
次要结局
- - To compare Recurrence Free Survival, Overall Survival, and Time toRecurrence of patients with resected primary GIST who are treatedwith adjuvant imatinib for a duration of 2 years with historical data- To assess the safety of imatinib given as adjuvant therapy for 2years in patients with resected primary GIST(2 Years)
研究者
研究点 (4)
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