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

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ClinicalTrials.gov Identifier: NCT01907815
Recruitment Status : Terminated (Lack of efficacy.)
First Posted : July 25, 2013
Results First Posted : April 6, 2018
Last Update Posted : April 6, 2018
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: Recurrent Adult Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Interventions: Drug: Akt Inhibitor GSK2141795
Other: Laboratory Biomarker Analysis
Drug: Trametinib

  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 9, 2013 to January 25, 2016. All recruitment done within medical clinic settings at The University of Texas MD Anderson Cancer Center, The University of Chicago and The University of Maryland Greenebaum Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study was terminated early, stopped due to lack of efficacy.

Reporting Groups
  Description
Trametinib 2.0 mg + GSK2141795 25 mg Trametinib 2.0 mg orally once daily (PO QD) and Akt inhibitor GSK2141795 25 mg PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Trametinib 1.5 mg + GSK2141795 50 mg Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity

Participant Flow:   Overall Study
    Trametinib 2.0 mg + GSK2141795 25 mg   Trametinib 1.5 mg + GSK2141795 50 mg
STARTED   17   7 
COMPLETED   16   7 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                0 



  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.
One participant withdrew prior to treatment so is included in baseline demographics but not in study analysis.

Reporting Groups
  Description
Trametinib 2.0 mg + GSK2141795 25 mg Trametinib 2.0 mg PO QD + GSK2141795 25 mg PO QD on days 1-28.
Trametinib 1.5 mg + GSK2141795 50 mg Trametinib 1.5 mg PO QD + GSK2141795 50 mg PO QD on days 1-28.
Total Total of all reporting groups

Baseline Measures
   Trametinib 2.0 mg + GSK2141795 25 mg   Trametinib 1.5 mg + GSK2141795 50 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   7   24 
Age 
[Units: Years]
Median (Full Range)
 68 
 (22 to 80) 
 69 
 (61 to 80) 
 69 
 (22 to 80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6  35.3%      3  42.9%      9  37.5% 
Male      11  64.7%      4  57.1%      15  62.5% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   17   7   24 


  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Most Frequently Reported Adverse Events (AE)   [ Time Frame: AE collected continuously over 28-day cycles and up to 28 days after last dose of study drug. ]

3.  Secondary:   Overall Survival of Participants Achieving CR/CRp   [ Time Frame: Up to 12 weeks ]

4.  Secondary:   Progression Free Survival of Participants Achieving CR/CRp   [ Time Frame: Up to 12 weeks ]

5.  Secondary:   Time to Progression for Participants Achieving CR/CRp   [ Time Frame: Up to 12 weeks ]

6.  Other Pre-specified:   Maximum Percentage Change in Total and Phospho-proteins   [ Time Frame: Baseline to 12 weeks post therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Other Pre-specified:   Percentage Change in Cellular Proteins   [ Time Frame: Baseline to day 28 post treatment ]
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: Nitin Jain, MD, Assistant Professor, Leukemia
Organization: The University of Texas MD Anderson Cancer Center
phone: 713-792-7734
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01907815     History of Changes
Other Study ID Numbers: NCI-2013-01354
NCI-2013-01354 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NCI 9443
2013-0001 ( Other Identifier: MD Anderson Cancer Center )
9443 ( Other Identifier: CTEP )
N01CM39 ( Other Grant/Funding Number: Federal Funding, NIH )
N01CM71 ( Other Grant/Funding Number: Federal Funding, NIH )
P30CA016672 ( U.S. NIH Grant/Contract )
First Submitted: July 22, 2013
First Posted: July 25, 2013
Results First Submitted: August 2, 2017
Results First Posted: April 6, 2018
Last Update Posted: April 6, 2018