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
- Conditions
- Gastrointestinal stromal tumors (GIST)
- Registration Number
- EUCTR2006-002267-11-BE
- Lead Sponsor
- ovartis Pharma Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 237
•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 dose of at least 400 mg daily and radiological confirmation of disease progression (RECIST criteria) during sunitinib therapy that was started at 50 mg daily dose (even if progression of disease occurred at a reduced dose) OR documented intorlerance (defined above in population) to imatinib and/or sunitinib.
•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
Visit 2
•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)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
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 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
•Women who are pregnant, breast feeding or adults of reproductive potential not employing an effective method of birth control. Post menopausal women must be amenorrheic for at least 12 months to be considered of nonchildbearing potential. Male and female patients must agree to employ an effective method of contraception during the study and for up to three months following discontinuation from the study. Effective methods of contraception are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate whether the efficacy of nilotinib is superior to imatinib as measured by progression free survival;Secondary Objective: •To compare the response rate and time to response of nilotinib with imatinib using<br> modified RECIST criteria to assess response<br><br>•To compare overall survival of nilotinib with imatinib<br> <br>•To assess the safety and tolerability of nilotinib as measured by rate and severity<br> of adverse events <br>;Primary end point(s): Progression free survival (PFS)
- Secondary Outcome Measures
Name Time Method