Evaluation of Nilotinib In Patients With Advanced Gastrointestinal Stromal Tumor (GIST)

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of GIST that is unresectable and/or metastatic

• Radiological confirmation of disease progression or intolerance to imatinib therapy at a any dose

• At least one measurable site of disease on CT scan at Visit-2

• WHO Performance Status of 0, 1 or 2 at Visit-2

• Patients must have normal organ, electrolyte, and marrow function at Visit-1 and Visit-2

Exclusion Criteria:

• Prior treatment with nilotinib or any other tyrosine kinase inhibitors except imatinib.

• Treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks

• Prior or concomitant malignancies other than GIST

• Impaired cardiac function at Visit-1 or 2

• Patients with severe and/or uncontrolled concurrent medical disease

• Use of therapeutic coumarin derivatives

• Use of any medications that prolong the QT interval

• Use of CYP3A4 inhibitors

• Patients who have undergone major surgery ≤ 2 weeks prior to Visit-1 or who have not recovered from side effects of such surgery

• 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

Other protocol-defined inclusion/exclusion criteria may apply