Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
NCT ID:
NCT01110668
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01110668
Study Brief:
Protocol Section:
NCT01110668