A randomized, open-label, multi-center study to evaluate the efficacy of nilotinib versus best supportive care with or without a tyrosine kinase inhibitor (investigator´s choice) in adult patients with gastrointestinal stromal tumors resistant to both imatinib and sunitinib

ovartis Pharma Services AG0 个研究点目标入组 237 人开始时间: 2008年7月4日最近更新: 2012年5月1日

适应症

试验速览

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 (CT/MRI) confirmation of disease progression (RECIST criteria) during imatinib therapy
•At least one measurable site of disease on CT/MRI scan at Visit 2, 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) yes
•F.1.3.1 Number of subjects for this age range

•Prior treatment with nilotinib or any other tyrosine kinase inhibitors or targeted agents with exception of imatinib and sunitinib
•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 (primary tumor or a relapse diagnosed and treated in the last 5 years) 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 1 or 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