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

Novartis

Status and phase

Completed

Phase 2

Conditions

Gastrointestinal Stromal Tumor

Treatments

Drug: Nilotinib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01110668

CAMN107DTR01T

Details and patient eligibility

About

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

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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