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AKT Inhibitor MK-2206 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01253447
Recruitment Status : Completed
First Posted : December 3, 2010
Results First Posted : January 7, 2015
Last Update Posted : January 7, 2015
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: 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
Interventions: Drug: Akt inhibitor MK2206
Other: laboratory biomarker analysis

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: October 27, 2010 to October 30, 2012. All recruitment done in medical clinics, either UT MD Anderson Cancer Center or Fred Hutchinson Cancer Research Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Akt Inhibitor MK2206) Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle

Participant Flow:   Overall Study
    Treatment (Akt Inhibitor MK2206)
STARTED   19 
COMPLETED   17 
NOT COMPLETED   2 
Adverse Event                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment (Akt Inhibitor MK2206) Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle

Baseline Measures
   Treatment (Akt Inhibitor MK2206) 
Overall Participants Analyzed 
[Units: Participants]
 19 
Age 
[Units: Years]
Mean (Full Range)
 72 
 (31 to 86) 
Gender 
[Units: Participants]
 
Female   7 
Male   12 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   1 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   1 
White   16 
More than one race   0 
Unknown or Not Reported   1 
Region of Enrollment 
[Units: Participants]
 
United States   19 


  Outcome Measures

1.  Primary:   Number of Participants With a Response of CR, CRp, or PR   [ Time Frame: 12 weeks of treatment ]

2.  Primary:   Treatment-related Non-hematological Toxicity   [ Time Frame: Up to 30 days post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Maximum Percentage Change in Apoptosis   [ Time Frame: Baseline to 12 courses ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Marina Konopleva, MD, PHD / Professor
Organization: The University of Texas (UT) MD Anderson Cancer Center
e-mail: CR_Study_Registration@mdanderson.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01253447     History of Changes
Obsolete Identifiers: NCT01654978
Other Study ID Numbers: NCI-2010-02186
NCI-2010-02186 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2010-0243 ( Other Identifier: M D Anderson Cancer Center )
8731 ( Other Identifier: CTEP )
N01CM00039 ( U.S. NIH Grant/Contract )
First Submitted: December 1, 2010
First Posted: December 3, 2010
Results First Submitted: December 23, 2014
Results First Posted: January 7, 2015
Last Update Posted: January 7, 2015