Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Acute Myeloid Leukemia

Part of paid clinical trials in Chicago, Illinois.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT01907815
Phase
PHASE2
Status
Terminated

Conditions

  • Recurrent Adult Acute Myeloid Leukemia
  • Untreated Adult Acute Myeloid Leukemia

Eligibility Criteria

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

Interventions

  • Akt Inhibitor GSK2141795 — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Trametinib — DRUG
    Given PO

Study Details

This phase II trial studies how well trametinib and protein kinase B (Akt) inhibitor GSK2141795 work in treating patients with acute myeloid leukemia. Trametinib and Akt inhibitor GSK2141795 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key Dates

Start date
Oct 31, 2013
Status verified
Apr 2018
Primary completion
Jan 31, 2016
Completion
Jan 31, 2016

Study Design

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

Arms

  • Experimental: Treatment (trametinib, Akt inhibitor GSK2141795)
    Trametinib orally once daily (PO QD) and Akt inhibitor GSK2141795 PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Complete Response Rate (CRR, Defined as CR+CRp) Assessed by AML 2003 Response Criteria [ Time Frame: First four cycles (16 weeks) of therapy, with evaluation after one full cycle of therapy (28 days) and up to 16 weeks for response ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
University of Maryland/Greenebaum Cancer CenterBaltimoreMaryland21201-
M D Anderson Cancer CenterHoustonTexas77030-

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