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MK2206 and Erlotinib Hydrochloride in Treating Patients With Advanced Non-Small Cell Lung Cancer Who Have Progressed After Previous Response to Erlotinib Hydrochloride Therapy

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ClinicalTrials.gov Identifier: NCT01294306
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : October 17, 2016
Last Update Posted : November 29, 2016
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: Adenosquamous Lung Carcinoma
Bronchioloalveolar Carcinoma
Large Cell Lung Carcinoma
Lung Adenocarcinoma
Recurrent Non-Small Cell Lung Carcinoma
Squamous Cell Lung Carcinoma
Interventions: Drug: Akt Inhibitor MK2206
Drug: Erlotinib Hydrochloride
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
EGFR-Mutated Tumors Patients with EGFR-mutated tumors.
EGFR Wild-Type Tumors Patients with EGFR wild-type tumors.

Participant Flow:   Overall Study
    EGFR-Mutated Tumors   EGFR Wild-Type Tumors
STARTED   45   35 
COMPLETED   45   35 
NOT COMPLETED   0   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.
No text entered.

Reporting Groups
  Description
EGFR-Mutated Tumors Patients with EGFR-mutated tumors.
EGFR Wild-Type Tumors Patients with EGFR wild-type tumors.
Total Total of all reporting groups

Baseline Measures
   EGFR-Mutated Tumors   EGFR Wild-Type Tumors   Total 
Overall Participants Analyzed 
[Units: Participants]
 45   35   80 
Age 
[Units: Years]
Median (Full Range)
 64 
 (44 to 86) 
 63 
 (40 to 83) 
 64 
 (40 to 86) 
Gender 
[Units: Participants]
     
Female   31   20   51 
Male   14   15   29 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   21   6   27 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   1   1   2 
White   20   27   47 
More than one race   0   0   0 
Unknown or Not Reported   3   1   4 
Region of Enrollment 
[Units: Participants]
     
United States   45   35   80 


  Outcome Measures

1.  Primary:   Disease-control Rate   [ Time Frame: At 12 weeks ]

2.  Primary:   Objective Response   [ Time Frame: Up to 2 years ]

3.  Secondary:   Median Progression-free Survival   [ Time Frame: Up to 2 years ]

4.  Secondary:   Toxicity of Akt Inhibitor MK2206 Plus Erlotinib Hydrochloride   [ Time Frame: Time Frame: Up to 2 years ]

5.  Secondary:   Median Overall Survival   [ Time Frame: Up to 2 Years ]


  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: DCC Project Administrator
Organization: California Cancer Consortium
phone: 626-256-4673 ext 60094
e-mail: CCCP@coh.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01294306     History of Changes
Other Study ID Numbers: NCI-2011-02578
NCI-2011-02578 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000695056
CHNMC-PHII-108
PhII-108 ( Other Identifier: City of Hope Comprehensive Cancer Center )
8698 ( Other Identifier: CTEP )
N01CM00038 ( U.S. NIH Grant/Contract )
N01CM00071 ( U.S. NIH Grant/Contract )
N01CM62209 ( U.S. NIH Grant/Contract )
P30CA033572 ( U.S. NIH Grant/Contract )
First Submitted: February 10, 2011
First Posted: February 11, 2011
Results First Submitted: August 23, 2016
Results First Posted: October 17, 2016
Last Update Posted: November 29, 2016