Who is sponsoring NCT01253447?

NCT01253447 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT01253447?

Interventions in NCT01253447: Akt inhibitor MK2206, laboratory biomarker analysis.

What condition does NCT01253447 study?

NCT01253447 studies Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a), Adult Acute Monocytic Leukemia (M5b), Adult Acute Myeloblastic Leukemia With Maturation (M2), Adult Acute Myeloblastic Leukemia Without Maturation (M1), Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Acute Myelomonocytic Leukemia (M4), Adult Erythroleukemia (M6a), Adult Pure Erythroid Leukemia (M6b), Recurrent Adult Acute Myeloid Leukemia.

Is NCT01253447 still recruiting?

NCT01253447 is currently completed. Last updated 27 July 2018.

Are results published for NCT01253447?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-07-27 · How we verify

NCT01253447

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 2 Study of the AKT Kinase Inhibitor MK-2206 in Patients With Relapsed Refractory Acute Myelogenous Leukemia

Completed Phase 2 Results posted Last updated 27 July 2018

What this trial tests

Phase 2 trial testing Akt inhibitor MK2206 in Adult Acute Megakaryoblastic Leukemia (M7) in 19 participants. Completed in 1 April 2014.

Timeline

1 October 2010

Primary endpoint
1 October 2013

1 April 2014

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	1 October 2010
Primary completion	1 October 2013
Estimated completion	1 April 2014
Sites	2 locations across United States

Drugs / interventions tested

Akt inhibitor MK2206 — full drug profile →
laboratory biomarker analysis — full drug profile →

Conditions studied

Adult Acute Megakaryoblastic Leukemia (M7) — all drugs for Adult Acute Megakaryoblastic Leukemia (M7) →
Adult Acute Minimally Differentiated Myeloid Leukemia (M0) — all drugs for Adult Acute Minimally Differentiated Myeloid Leukemia (M0) →
Adult Acute Monoblastic Leukemia (M5a) — all drugs for Adult Acute Monoblastic Leukemia (M5a) →
Adult Acute Monocytic Leukemia (M5b) — all drugs for Adult Acute Monocytic Leukemia (M5b) →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Adult Acute Megakaryoblastic Leukemia (M7) or Adult Acute Minimally Differentiated Myeloid Leukemia (M0). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of Participants With a Response of CR, CRp, or PR
Time frame: 12 weeks of treatment
Responses defined by International Working Group (IWG) 2003 Response Criteria: Morphologic Complete Response (CR): Peripheral blood counts: No circulating blasts, Neutrophil count \>/= 1.0 x10\^9/L, Platelet count \>/= 100 x10\^9/L; Bone marrow aspirate and biopsy: \</= 5% blasts, No detectable Auer rods, No extramedullary leukemia. Partial Response (PR): No circulating blasts, Neutrophil count \>
Number of Participants With Treatment-related Non-hematological Toxicity
Time frame: Up to 30 days post-treatment
Toxicity assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, version 4.0 (CTCAEv4.0)

Sponsor's own description

This phase II trial is studying how well AKT inhibitor MK-2206 works in treating patients with relapsed or refractory acute myeloid leukemia (AML). AKT inhibitor MK-2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Role of PI3K/AKT pathway in cancer: the framework of malignant behavior.
Jiang N, Dai Q, Su X, Fu J, et al · · 2020 · cited 419× · PMID 32333246 · DOI 10.1007/s11033-020-05435-1
Maximising the potential of AKT inhibitors as anti-cancer treatments.
Brown JS, Banerji U. · · 2017 · cited 184× · PMID 27919797 · DOI 10.1016/j.pharmthera.2016.12.001
The Warburg effect: evolving interpretations of an established concept.
Chen X, Qian Y, Wu S. · · 2015 · cited 177× · PMID 25277420 · DOI 10.1016/j.freeradbiomed.2014.08.027
Targeting the RAS oncogene.
Takashima A, Faller DV. · · 2013 · cited 95× · PMID 23360111 · DOI 10.1517/14728222.2013.764990
Targeting PI3K/Akt/mTOR in AML: Rationale and Clinical Evidence.
Darici S, Alkhaldi H, Horne G, Jørgensen HG, et al · · 2020 · cited 87× · PMID 32932888 · DOI 10.3390/jcm9092934
Preclinical and early clinical evaluation of the oral AKT inhibitor, MK-2206, for the treatment of acute myelogenous leukemia.
Konopleva MY, Walter RB, Faderl SH, Jabbour EJ, et al · · 2014 · cited 71× · PMID 24583795 · DOI 10.1158/1078-0432.ccr-13-1978
Understanding of leukemic stem cells and their clinical implications.
Wang X, Huang S, Chen JL. · · 2017 · cited 56× · PMID 28137304 · DOI 10.1186/s12943-016-0574-7
Inhibitors of Chemoresistance Pathways in Combination with Ara-C to Overcome Multidrug Resistance in AML. A Mini Review.
Fajardo-Orduña GR, Ledesma-Martínez E, Aguiñiga-Sánchez I, Mora-García ML, et al · · 2021 · cited 27× · PMID 34066940 · DOI 10.3390/ijms22094955

Verify or expand the search:

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01253447 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 27 July 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01253447.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing