NCT03501368

Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma

Phase 1 Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to determine the risks and benefits of ceritinib (ZYKADIA) given in combination with trametinib (MEKINIST) in patients who have progressed on prior melanoma therapy.

Detailed description

Ceritinib that has been approved for patients with metastatic non-small cell lung cancer (NSCLC) by the US Food and Drug Administration (FDA). While ceritinib is not currently FDA-approved specifically in melanoma, researchers believe ceritinib may also help keep melanoma cancer cells from growing and therefore potentially help patients with melanoma as well. Trametinib is currently FDA-approved for melanoma with a BRAFV600-mutation.

Conditions

• Melanoma
• Unresectable Melanoma
• Advanced Melanoma

Interventions

Type	Name	Description
DRUG	Ceritinib	Participants will take ceritinib by mouth (PO) once daily at a dose of up to 450 mg (3 capsules of 150 mg)
DRUG	Trametinib	Participants will take trametinib by mouth at a dose of 2 mg daily

Timeline

• Start date: 2018-06-27
• Primary completion: 2022-10-28
• Completion: 2024-12-30
• First posted: 2018-04-18
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study