EUCTR2008-004758-34-GB进行中（未招募）1 期
A randomized, open-label, multi-center phase III study to evaluate the efficacy and safety of nilotinib versus imatinib in adult patients with unresectable or metastatic gastrointestinal stromal tumors (GIST). - N/A
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 644
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
- •Age =18 years
- •At least one measurable site of disease on CT/MRI scan as defined by RECIST criteria (refer to Post-text supplement 2) based on investigator’s assessment
- •Histologically confirmed diagnosis of GIST which is unresectable and/or metastatic and either:
- •have not received any prior anti-neoplastic therapy other than adjuvant imatinib. Note: newly diagnosed patients may have received up to 14 days of treatment with imatinib for disease management while awaiting entry to the study
- •had no clinical or radiological evidence of disease during the adjuvant treatment with imatinib, have recurrent GIST = 6 months after stopping adjuvant treatment with imatinib, and who have subsequently not received any other therapies,
- •For patients with recurrent GIST after stopping adjuvant imatinib two CT scans will be required prior to study entry: one demonstrating absence of disease following completion of adjuvant imatinib and another demonstrating recurrence of disease = 6 months after discontinuation of adjuvant imatinib.
- •WHO Performance Status of 0, 1 or 2
- •Patients must have normal organ, electrolyte, and marrow function as defined below:
- •Absolute Neutrophil Count (ANC) = 1.5 x 109/L
- •Hemoglobin = 9.0 g/dL
- •Platelets = 100 x 109/L
- •ALT and AST = 2.5 x upper limit of normal (ULN) or = 5.0 x ULN if considered due to liver metastases
- •Alkaline phosphatase = 2.5 x ULN or = 5.0 x ULN if considered due to liver metastases
- •Serum bilirubin = 1.5 x ULN
- •Serum lipase and amylase = 1.5 x ULN
- •Serum potassium within the normal limits or corrected to within normal limits with supplements
- •Total calcium (corrected for serum albumin) within the normal limits or corrected to within normal limits with supplements
- •Serum magnesium within the normal limits or corrected to within normal limits with supplements
- •Serum phosphorous within the normal limits or corrected to within normal limits with supplements
- •Serum creatinine = 1.5 x ULN
- •A written informed consent must be obtained
- •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
- •Any prior anti-neoplastic therapy (eg TKIs, chemotherapy, investigational therapy) with the exception of patients who have received adjuvant imatinib or patients with newly diagnosed metastatic/unresectable GIST whose disease requires therapy while awaiting entry to the study, up to 14 days of treatment with imatinib (a washout period of a minimum of 4 days will be required prior to the first dose of study medication).
- •History of active malignancy (other than GIST) within 10 years prior to study entry with the exception of previous or concomitant basal cell skin cancer, previous cervical carcinoma in situ
- •Impaired cardiac function, including any one of the following:
- •LVEF < 45% or below the institutional lower limit of the normal range (whichever is higher) as determined by echocardiogram or MUGA scan.
- •Inability to determine the QT interval on ECG.
- •Complete left bundle branch block.
- •Use of a ventricular-paced pacemaker.
- •Congenital long QT syndrome or a known family history of long QT syndrome.
- •History of or presence of clinically significant ventricular or atrial tachyarrhythmias.
- •Clinically significant resting bradycardia (< 50 beats per minute).
- •QTc > 450 msec (using the QTcF formula) as determined by central reading. If QTcF > 450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc.
- •History or signs of prior myocardial infarction (during the last 12 months).
- •History of unstable angina (during the last 12 months).
- •Other clinically significant heart disease (e.g. congestive heart failure or uncontrolled hypertension).
- •Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol e.g. uncontrolled diabetes, active or uncontrolled infection.
- •History of significant congenital or acquired bleeding disorder unrelated to cancer.
- •Known symptomatic brain metastases.
- •Major surgery within 4 weeks prior to randomization or who have not recovered from prior surgery.
- •History of non-compliance to medical regimens or inability to grant consent.
- •Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either safely discontinued or switched to a different medication prior to starting study drug administration. Please see torsades.org/medical-pros/drug-lists/printable-drug-list.cfm or http://www.arizonacert.org/medical-pros/drug-lists/drug-lists for a list of agents that prolong the QT interval. This list may not be comprehensive.
- •Patients actively receiving therapy with strong CYP3A4 inhibitors and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. See Post-text supplement 4 for a list of these medications. This list may not be comprehensive.
- •Patients actively receiving therapy with strong CYP3A4 inducers and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. See Post-t
研究者
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