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 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT00633295
Eligibility Criteria:
Inclusion criteria:
* Age ≥ 18 years at Visit 1
* Radiological confirmation of disease progression (CT scan PET-CT, or MRI) during imatinib therapy, on 600- 800 mg per day for at least 6 weeks.
* Radiological confirmation of disease progression (CT scan or MRI and PET-CT) during 2nd line TK inhibitor therapy.
* Patients who were intolerant to Imatinib or second line TK inhibitor (like :sunitinib). Intolerance (at any dose and/or duration), is defined as patients who did not progress on imatinib or sunitinib and have discontinued imatinib and or sunitinib therapy due to any ≥ Grade 3 adverse events that persist in spite of optimal supportive care. Patients with Grade 2 adverse events related to imatinib or sunitinib therapy, in spite of optimal supportive care measures, that persist for ≥ one month or that recurs for more than 3 times whether the dose is reduced or discontinued will also qualify patients as intolerant
Exclusion criteria:
* Prior treatment with nilotinib
* Treatment with any investigational drug ≤ 4 weeks prior to Visit 1 with the exception of imatinib and sunitinib therapy .
Other protocol-defined inclusion/exclusion criteria may apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00633295
Study Brief:
Protocol Section:
NCT00633295