Trametinib With or Without GSK2141795 in Treating Patients With Metastatic Uveal Melanoma

Conditions

• Recurrent Uveal Melanoma
• Stage IV Uveal Melanoma AJCC v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Pharmacological Study — OTHER
  Correlative studies
• Trametinib — DRUG
  Given PO
• Uprosertib — DRUG
  Given PO

Study Details

This randomized phase II trial studies how well trametinib with or without Akt inhibitor GSK2141795 (GSK2141795) works in treating patients with uveal melanoma that has spread to other parts of the body (metastatic). Trametinib and GSK2141795 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether trametinib is more effective with or without GSK2141795 in treating patients with metastatic uveal melanoma.

Key Dates

Start date

Nov 21, 2013

Status verified

Jan 2026

Primary completion

Sep 1, 2017

Completion

Jul 2, 2026

Study Design

Enrollment

42 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A (trametinib)
  Patients receive trametinib PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who experience objective disease progression may crossover to Arm B. (no patients will be enrolled to Arm B or Crossover therapy as of 11/6/2015)
• Experimental: Arm B (trametinib, Akt inhibitor GSK2141795)
  Patients receive trametinib PO QD and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Time to Progression (Progression-free Survival [PFS]), Defined From the Date of Randomization to the Date of Documented Progression or Death Per RECIST [ Time Frame: from randomization to the earlier date of objective disease progression or death ]

Locations (5)

Find similar trials in Atlanta, GA