Gastrointestinal stromal tumors (GIST)
Conditions
Interventions
Product Name: nilotinib
Product Code: AMN107
Pharmaceutical Form: Capsule, hard
Trade Name: Glivec
Pharmaceutical Form: Capsule, hard
Sponsors
Novartis Pharma Services
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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 therapy •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 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) 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
Exclusion criteria
Exclusion criteria: •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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 modified RECIST criteria to assess response •To compare overall survival of nilotinib with imatinib •To assess the safety and tolerability of nilotinib as measured by rate and severity of adverse events ;Primary end point(s): Progression free survival (PFS) | — |
Countries
Belgium, Czech Republic, France, Germany, Italy, Netherlands, Spain
Outcome results
None listed