Selumetinib and Akt Inhibitor MK2206 in Treating Patients With Stage III or Stage IV Melanoma Who Failed Prior Therapy With Vemurafenib or Dabrafenib

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01519427
Phase
PHASE2
Status
Terminated

Conditions

  • Recurrent Melanoma
  • Stage IIIA Melanoma
  • Stage IIIB Melanoma
  • Stage IIIC Melanoma
  • Stage IV Melanoma

Eligibility Criteria

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

Interventions

  • Akt inhibitor MK2206 — DRUG
    Given PO
  • selumetinib — DRUG
    Given PO
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

This phase II trial studies how well selumetinib and Akt inhibitor MK2206 works in treating patients with stage III or stage IV melanoma who failed prior therapy with vemurafenib or dabrafenib. Selumetinib and Akt inhibitor MK2206 stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether giving selumetinib and Akt inhibitor MK2206 together is an effective treatment for advanced melanoma.

Key Dates

Start date
Jan 31, 2012
Status verified
Jan 2014
Primary completion
May 31, 2013
Completion
May 31, 2013

Study Design

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

Arms

  • Experimental: Treatment (selumetinib and Akt inhibitor MK2206)
    Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.

Primary Outcome Measure

Objective Response [ Time Frame: On-treatment date to date of progressive disease (assessed up to 30 days after end of treatment) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322-
Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
Virginia Commonwealth University/Massey Cancer CenterRichmondVirginia23298-

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