EUCTR2008-004758-34-DE进行中（未招募）不适用
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
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 736
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 =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
- •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 (e.g. 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
- •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 rescreened
- •History or signs of prior myocardial infarction (during the last 12
- •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
- •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-text supplement 4 for a
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研究者
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