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Randomized Phase II Study of AZD6244 (Mitogen-activated Protein Kinase Inhibitor) MEK-Inhibitor With Erlotinib in KRAS Wild Type Advanced Non-Small Cell Lung Cancer (NSCLC) and a Randomized Phase II Study of AZD6244 With Erlotinib in Mutant KRAS Adva...

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of California, Davis
University of Chicago
University of Southern California
Beckman Research Institute
Information provided by (Responsible Party):
Arun Rajan, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01229150
First received: October 26, 2010
Last updated: October 23, 2014
Last verified: October 2014
Results First Received: October 23, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non Small Cell Lung Carcinoma
Interventions: Drug: AZD6244
Drug: Erlotinib
Drug: AZD6244 + Erlotinib

  Participant Flow
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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
89 participants were enrolled and 79 participants started. 10 patients should be classified as screen failures. Of the 10, one died during the screening process, and one patient withdrew during the screening process.

Reporting Groups
  Description
KRAS Mut 2

KRAS Mutant patients randomized to combination therapy arm

AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd.

KRAS Mut 1

KRAS Mutant patients randomized to monotherapy arm

AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day).

WT KRAS 1

Wild-Type KRAS patients randomized to monotherapy arm

Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd

WT KRAS 2

Wild-Type KRAS patients randomized to combination therapy arm

AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd.


Participant Flow:   Overall Study
    KRAS Mut 2     KRAS Mut 1     WT KRAS 1     WT KRAS 2  
STARTED     30     11     19     19  
COMPLETED     28     9     19     19  
NOT COMPLETED     2     2     0     0  
Toxicity                 2                 2                 0                 0  



  Baseline Characteristics
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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
KRAS Mut 2

KRAS Mutant patients randomized to combination therapy arm

AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd.

KRAS Mut 1

KRAS Mutant patients randomized to monotherapy arm

AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day).

WT KRAS 1

Wild-Type KRAS patients randomized to monotherapy arm

Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd

WT KRAS 2

Wild-Type KRAS patients randomized to combination therapy arm

AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd.

Total Total of all reporting groups

Baseline Measures
    KRAS Mut 2     KRAS Mut 1     WT KRAS 1     WT KRAS 2     Total  
Number of Participants  
[units: participants]
  30     11     19     19     79  
Age  
[units: years]
Mean ± Standard Deviation
  66.05  ± 9.648     64.31  ± 13.76     63.75  ± 13.6     64.84  ± 8.10     65.22  ± 9.46  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     16     5     11     10     42  
>=65 years     14     6     8     9     37  
Gender  
[units: participants]
         
Female     16     7     9     6     38  
Male     14     4     10     13     41  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     0     0     0     0  
Asian     1     1     0     1     3  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     3     2     4     4     13  
White     26     8     14     13     61  
More than one race     0     0     0     0     0  
Unknown or Not Reported     0     0     1     1     2  
Ethnicity (NIH/OMB)  
[units: participants]
         
Hispanic or Latino     1     2     2     3     8  
Not Hispanic or Latino     25     9     15     12     61  
Unknown or Not Reported     4     0     2     4     10  
Region of Enrollment  
[units: participants]
         
United States     30     11     19     19     79  



  Outcome Measures
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1.  Primary:   Progression Free Survival   [ Time Frame: 2.1 to 4 months ]

2.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 42 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Arun Rajan
Organization: National Cancer Institute
phone: 301-594-5322
e-mail: rajana@mail.nih.gov


Publications:

Responsible Party: Arun Rajan, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT01229150     History of Changes
Obsolete Identifiers: NCT01239290
Other Study ID Numbers: 100218, 10-C-0218
Study First Received: October 26, 2010
Results First Received: October 23, 2014
Last Updated: October 23, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration