Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT03501368
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Melanoma
  • Melanoma
  • Unresectable Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 27, 2018
Status verified
Feb 2026
Primary completion
Oct 28, 2022
Completion
Dec 30, 2024

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Trametinib + Ceritinib Treatment
    Study treatment will be given in cycles. Each cycle will be 4 weeks (28 days). Post-Treatment (follow-up) Period: Participants will return to the study site between 30-40 days after the last dose of trametinib + ceritinib for an end-of-treatment assessment. Additional follow-up will occur for related Adverse Events (AEs) that are not resolved by this time and related Serious Adverse Events (SAEs) that occur after the time of this visit. Participants will be followed for survival every 3 months for the first year following end of treatment, and then every 6 months for up to 5 years after end of treatment.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) and recommended Phase 2 Dose (RP2D) [ Time Frame: Up to 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

Find similar trials in Tampa, FL

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FL

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