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 — DRUGGiven PO
- Laboratory Biomarker Analysis — OTHERCorrelative studies
- Trametinib — DRUGGiven 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | - |
| University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | 21201 | - |
| M D Anderson Cancer Center | Houston | Texas | 77030 | - |
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