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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT02501551
Eligibility Criteria:
Inclusion Criteria:
1. Histologically or cytologically proven melanoma with stage IV or unresectable stage III disease
2. c-kit mutations
3. performance status of 0, 1, and 2
4. Have progressed after 1 previous systemic treatment containing dacarbazine, temozolomide, or immunotherapy for metastatic melanoma
5. Patients with central nervous system metastasis must have stable neurologic function without evidence of central nervous system progression within 8 weeks
6. Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumors v1.1
Exclusion Criteria:
1. Major surgery or radiation therapy within 4 weeks of starting the study treatment
2. History of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease
3. Have received greater than or equal to 2 previous chemotherapy-containing systemic treatment regimens
4. Patients with BRAF or NRAS mutation
5. Prior therapy with a c-kit inhibitor
6. Significant history of cardiac disease, myocardial infarction, or current cardiac ventricular arrhythmias requiring medication
7. Major surgery within 4 weeks before start of study treatment
8. Active gastrointestinal bleeding
9. Patients treated with co-administration of a strong CYP3A4 inducers
10. Adequate Hematologic, Biochemical, and Organ Function
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT02501551
Study Brief:
Protocol Section:
NCT02501551