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

Phase 2

Completed

• Conditions: Gastrointestinal Stromal Tumor
• Interventions: Drug: Nilotinib

• Registration Number: NCT01110668
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2010-04-22
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-27
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-24
• Last Update Posted: 2017-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nilotinib	Nilotinib	-

Primary Outcome Measures

Name	Time	Method
To evaluate time-to-disease progression in patients with advanced gastrointestinal stromal tumor (GIST) previously treated with imatinib ≥600 mg.	every 8 weeks

Secondary Outcome Measures

Name	Time	Method
To determine progression-free survival and the response rate of nilotinib in patients with advanced GIST previously treated with imatinib ≥600 mg.	6 months

Trial Locations

Locations (1)

Novartis Investigative Site; 🇹🇷 Izmir, Turkey