Regorafenib, C-kit Mutated Malignant Melanoma, 2nd Line Therapy

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase II trial of regorafenib in patients with metastatic melanoma harboring c-Kit mutations and/or amplifications of c-Kit gene copy number. The primary end point is disease control rate (DCR), and the secondary end points are safety, response rate (RR), progression free survival (PFS), and overall survival (OS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University

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