A randomized, open-label,multi-center study to evaluate the efficacy of nilotinib versus imatinib in adult patients with gastrointestinal stromal tumors resistant to imatinib and resistant/intolerant to sunitinib - A2201

ovartis Pharma Services0 个研究点目标入组 210 人开始时间: 2006年10月4日最近更新: 2015年1月12日

研究概览

暂无简介。

•Age : older than 18 years at Visit 1
•Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic
•and therefore not amenable to surgery or combined modality with curative intent
•prior to or at Visit 1
•Radiological confirmation of disease progression (CT scan or MRI) during imatinib
•Radiological confirmation of disease progression (CT scan or MRI) during sunitinib
•therapy. For those patients who were intolerant to sunitinib, intolerance (at any
•dose and/or duration), is defined as patients who did not progress on sunitinib and
•have discontinued sunitinib therapy due to any = Grade 2 adverse events that
•persist in spite of optimal supportive care.
•At least one measurable site of disease on CT/MRI scan at Visit 1, as defined by
•RECISTcriteria (see Post Text Suppl 3 for details)
•WHO Performance Status of 0, 1 or 2 at Visit 1 and 2
•Patients must have normal organ, electrolyte, and marrow function at Visit 1 and
•Ability to understand and willingness to sign a written informed consent
•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) no
•F.1.3.1 Number of subjects for this age range

•Prior treatment with nilotinib
•Documented intolerance or history of allergy to imatinib
•Unable to tolerate imatinib run-in of 7 days minimum
•Treatment with any cytotoxic and/or investigational cytotoxic drug = 4 weeks (6
•weeks for nitrosurea or mitomycin C) prior to Visit 1 with the exception of imatinib
•and sunitinib targeted therapy
•Prior or concomitant malignancies (with a relapse in the last 5 years or receiving
•active treatment) other than GIST with the exception of previous or concomitant
•basal cell skin cancer or previous cervical carcinoma in situ
•Impaired cardiac function at Visit 1or 2
•Use of therapeutic coumarin derivatives
•Patients who are currently receiving treatment with medications that have the
•potential to prolong the QT interval
•Patients who have undergone major surgery = 2 weeks prior to Visit 1 or who
•have not recovered from side effects of such therapy
•Patients who have received wide field radiotherapy = 4 weeks or limited field
•radiation for palliation < 2 weeks prior to Visit 1 or who have not recovered from
•side effects of such therapy

发起方

ovartis Pharma Services