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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...

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ClinicalTrials.gov Identifier: NCT01229150
Recruitment Status : Completed
First Posted : October 27, 2010
Results First Posted : October 29, 2014
Last Update Posted : May 23, 2017
Sponsor:
Collaborators:
University of California, Davis
University of Chicago
University of Southern California
City of Hope Medical Center
Information provided by (Responsible Party):
Arun Rajan, M.D., National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Non Small Cell Lung Carcinoma
Interventions: Drug: AZD6244
Drug: Erlotinib
Drug: AZD6244 + Erlotinib

  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
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

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 
Overall Participants Analyzed 
[Units: Participants]
 30   11   19   19   79 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      16  53.3%      5  45.5%      11  57.9%      10  52.6%      42  53.2% 
>=65 years      14  46.7%      6  54.5%      8  42.1%      9  47.4%      37  46.8% 
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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      16  53.3%      7  63.6%      9  47.4%      6  31.6%      38  48.1% 
Male      14  46.7%      4  36.4%      10  52.6%      13  68.4%      41  51.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      1   3.3%      2  18.2%      2  10.5%      3  15.8%      8  10.1% 
Not Hispanic or Latino      25  83.3%      9  81.8%      15  78.9%      12  63.2%      61  77.2% 
Unknown or Not Reported      4  13.3%      0   0.0%      2  10.5%      4  21.1%      10  12.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      1   3.3%      1   9.1%      0   0.0%      1   5.3%      3   3.8% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      3  10.0%      2  18.2%      4  21.1%      4  21.1%      13  16.5% 
White      26  86.7%      8  72.7%      14  73.7%      13  68.4%      61  77.2% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      1   5.3%      1   5.3%      2   2.5% 
Region of Enrollment 
[Units: Participants]
Count of Participants
         
United States   30   11   19   19   79 
Histology 
[Units: Participants]
Count of Participants
         
Lung Cancer Adenocarcinoma   30   11   15   15   71 
Squamous cell   0   0   4   4   8 
Mutational Status [1] 
[Units: Participants]
Count of Participants
         
EGFR Mutated (L858R)   30   11   1   1   43 
EGFR Wild Type   0   0   18   18   36 
KRAS G12A   6   0   0   0   6 
KRAS G12C   8   4   0   0   12 
KRAS G12D   1   1   0   0   2 
KRAS G12K   1   1   0   0   2 
KRAS G12R   0   1   0   0   1 
KRAS G12S   1   0   0   0   1 
KRAS G12V   9   4   0   0   13 
KRAS Q61H   2   0   0   0   2 
KRAS Q61L   2   0   0   0   2 
KRAS   0   0   0   0   0 
[1] EGFR (epidermal growth factor receptor); KRAS (Kirsten Rat Sarcoma Viral Oncogene homolog). KRAS G12A (e.g. G is glycine, 12 is the codon or position and A is amino acid alanine); C is cysteine, D is aspartic acid, K is lysine, R is arginine, S is serine, V is valine, Q is glutamine, H is histidine, and L is leucine.
Eastern Cooperative Oncology Group (ECOG) [1] 
[Units: Participants]
Count of Participants
         
 3   1   2   2   8 
 14   5   11   7   37 
 13   5   6   10   34 
[1] ECOG Performance Status criteria: Grade 0 is normal activity. Fully active, able to carry on all pre-disease performance without restriction. Grade 1 is symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work). Grade 2 is in bed <50% of the time. Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.
No. of Prior Regimens 
[Units: Participants]
Count of Participants
         
 12   6   10   8   36 
 18   5   9   11   43 
Smoking 
[Units: Participants]
Count of Participants
         
Current   9   0   0   0   9 
Former   21   11   13   16   61 
Never-smoker   0   0   6   3   9 


  Outcome Measures

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

Measure Type Primary
Measure Title Progression Free Survival
Measure Description Time between the first day of treatment to the day of disease progression. Progressive disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that's the smallest on study). In addition to the relative increase of 20% of at least 5mm. (Note: the appearance of one or more lesions is also considered progression).
Time Frame 2.1 to 4 months  

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.


Measured Values
   KRAS Mut 2   KRAS Mut 1   WT KRAS 1   WT KRAS 2 
Participants Analyzed   30   11   19   19 
Progression Free Survival 
[Units: Months]
Median (95% Confidence Interval)
 2.3 
 (2.0 to 4.6) 
 4.0 
 (2.9 to 7.8) 
 2.4 
 (1.3 to 3.7) 
 2.1 
 (1.8 to 5.1) 


Statistical Analysis 1 for Progression Free Survival
Groups [1] KRAS Mut 2 vs. KRAS Mut 1
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Log Rank
P Value [4] 0.24
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Progression Free Survival
Groups [1] WT KRAS 1 vs. WT KRAS 2
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Log Rank
P Value [4] 0.75
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



2.  Primary:   Objective Response   [ Time Frame: Up to 37 months ]

Measure Type Primary
Measure Title Objective Response
Measure Description Objective response is complete response + partial response. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame Up to 37 months  

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.
There were no partial or complete responses in the KRAS mut 1 arm.

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.


Measured Values
   KRAS Mut 2   KRAS Mut 1   WT KRAS 1   WT KRAS 2 
Participants Analyzed   30   11   19   19 
Objective Response 
[Units: Participants]
 3   0   1   2 

No statistical analysis provided for Objective Response



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

Measure Type Secondary
Measure Title Number of Participants With Adverse Events
Measure Description Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
Time Frame 42 months  

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.
The combination of toxicities allows for a more robust understanding of the combined therapy toxicities. The dosage of the combination of erlotinib plus AZD6244 was the same whether the pt has a KRAS mutation versus KRAS wild type. KRAS is a molecular mutation and does not change whether or not a pt has toxicities to the combination of therapies.

Reporting Groups
  Description
KRAS Mut 2 & WT KRAS 2

KRAS Mutant patients randomized to combination therapy arm

AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS 2 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


Measured Values
   KRAS Mut 2 & WT KRAS 2   KRAS Mut 1   WT KRAS 1 
Participants Analyzed   49   11   19 
Number of Participants With Adverse Events 
[Units: Participants]
 49   9   18 

No statistical analysis provided for Number of Participants With Adverse Events



4.  Secondary:   Percentage of Participants With Disease Control/Stabilization   [ Time Frame: 3 cycles or up to 84 days ]

Measure Type Secondary
Measure Title Percentage of Participants With Disease Control/Stabilization
Measure Description Disease control/stabilization is the percentage of participants with partial response (PR) + complete response (CR) + stable disease (SD). Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10mm. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions.), taking as reference the smallest sum diameters.
Time Frame 3 cycles or up to 84 days  

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.


Measured Values
   KRAS Mut 2   KRAS Mut 1   WT KRAS 1   WT KRAS 2 
Participants Analyzed   30   11   19   19 
Percentage of Participants With Disease Control/Stabilization 
[Units: Percentage of participants]
Number (95% Confidence Interval)
 43 
 (25.5 to 52.6) 
 89 
 (51.8 to 99.7) 
 47 
 (24.4 to 71.1) 
 35.3 
 (14.2 to 61.7) 

No statistical analysis provided for Percentage of Participants With Disease Control/Stabilization



5.  Secondary:   Overall Survival   [ Time Frame: Up to 26 months ]

Measure Type Secondary
Measure Title Overall Survival
Measure Description Time between the first day of treatment to the time of death.
Time Frame Up to 26 months  

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.


Measured Values
   KRAS Mut 2   KRAS Mut 1   WT KRAS 1   WT KRAS 2 
Participants Analyzed   30   11   19   19 
Overall Survival 
[Units: Months]
Median (95% Confidence Interval)
 21.8 [1] 
 (5.7 to N/A) 
 10.5 [1] 
 (5.7 to N/A) 
 6.3 
 (2.6 to 19.5) 
 12.9 
 (3.5 to 25.4) 
[1] The upper end of the confidence interval is undefined because there were too few events to calculate.


Statistical Analysis 1 for Overall Survival
Groups [1] WT KRAS 1 vs. WT KRAS 2
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Log Rank
P Value [4] 0.51
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Overall Survival
Groups [1] KRAS Mut 2 vs. KRAS Mut 1
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Log Rank
P Value [4] 0.81
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



6.  Secondary:   Percentage of Th17 in Cluster of Differentiation 4 (CD4)+T Cells at Baseline in Relation to Response   [ Time Frame: Pretreatment - Cycle 1 Day 1 ]

Measure Type Secondary
Measure Title Percentage of Th17 in Cluster of Differentiation 4 (CD4)+T Cells at Baseline in Relation to Response
Measure Description First the number of T cells that are CD4+ is determined by staining with an antibody to CD4 and measured in a flow cytometer. Then the number of Th17+ cells is determined by staining with an antibody to IL-17 and measured in a flow cytometer. Then the percentage of CD4+ cells that are also Th17 cells is determined as a simple ratio, i.e. Th17cells/CD4 cells. This ratio is reported here for each category of KRAS mutation status for whom we had patients.
Time Frame Pretreatment - Cycle 1 Day 1  

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 participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. For all other cohorts, the numbers analyzed indicates some samples were either not drawn or could not be located.

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 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.


Measured Values
   KRAS Mut 2   KRAS Mut 1   WT KRAS 2 
Participants Analyzed   15   4   9 
Percentage of Th17 in Cluster of Differentiation 4 (CD4)+T Cells at Baseline in Relation to Response 
[Units: Percentage of Th17 in CD4+T Cells]
Mean (Standard Deviation)
 0.19  (0.18)   0.11  (0.05)   0.34  (0.27) 

No statistical analysis provided for Percentage of Th17 in Cluster of Differentiation 4 (CD4)+T Cells at Baseline in Relation to Response



7.  Secondary:   Number of Participants With a Reduction in Phosphorylated Extracellular Signal-Regulated Kinases (p-ERK) in Lymphocytes   [ Time Frame: Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment) ]

Measure Type Secondary
Measure Title Number of Participants With a Reduction in Phosphorylated Extracellular Signal-Regulated Kinases (p-ERK) in Lymphocytes
Measure Description Level of p-ERK was measured by the median channel cumber of fluorescence intensity. Data are relative to the level before therapy begins(C1D1).Then we see what the level was after therapy & compare. Every value after therapy is compared to pre-therapy, & every patient is their own control. To do that, we make C1D1 equal to 1 for every patient & then compare the pERK level after therapy by looking at the fold change in pERK level.
Time Frame Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)  

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.
Re: number of participants analyzed: Samples were either not drawn or could not be located. WT KRAS 1/WT KRAS 2 are missing because the effect of treatment on the Ras-Raf-MEK-ERK pathway as measured by a reduction in phosphorylated extracellular signal-regulated kinases (p-ERK) in lymphocytes was evaluated in patients with KRAS-mutated tumors only.

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).


Measured Values
   KRAS Mut 2   KRAS Mut 1 
Participants Analyzed   17   4 
Number of Participants With a Reduction in Phosphorylated Extracellular Signal-Regulated Kinases (p-ERK) in Lymphocytes 
[Units: Participants]
   
Cycle 1 Day 1   NA [1]   NA [1] 
Cycle 1 day 2   17   4 
Cycle 1 day 14   14   2 
[1] C1D1 is NA because every other time point, pERK level was normalized against C1D1; all the C1D1 values were set to 1.


Statistical Analysis 1 for Number of Participants With a Reduction in Phosphorylated Extracellular Signal-Regulated Kinases (p-ERK) in Lymphocytes
Groups [1] KRAS Mut 1
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Wilcoxon matched-pairs signed rank test
P Value [4] <0.0007
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  P-value was determined by comparison by the level of p-ERK at cycle 1 day 1 to cycle 1 day 2.

Statistical Analysis 2 for Number of Participants With a Reduction in Phosphorylated Extracellular Signal-Regulated Kinases (p-ERK) in Lymphocytes
Groups [1] KRAS Mut 1
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Wilcoxon matched-pairs signed rank test
P Value [4] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  P-value was determined by comparison by the level of p-ERK at cycle 1 day 1 to cycle 1 day 14.

Statistical Analysis 3 for Number of Participants With a Reduction in Phosphorylated Extracellular Signal-Regulated Kinases (p-ERK) in Lymphocytes
Groups [1] KRAS Mut 1
Statistical Test Type [2] Superiority or Other
Statistical Method [3] Wilcoxon matched-pairs signed rank test
P Value [4] 0.0209
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  4 patients in this group; statistically underpowered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  No text entered.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[4] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  P-value was determined by comparison by the level of p-ERK at cycle 1 day 2 and cycle 1 day 14.



8.  Other Pre-specified:   Number of Participants With Changes in a Tumor's MIB-1 (Ki-67) Rate   [ Time Frame: At enrollment ]

Measure Type Other Pre-specified
Measure Title Number of Participants With Changes in a Tumor's MIB-1 (Ki-67) Rate
Measure Description Changes in a tumor's MIB-1 (Ki-67) rate was to be assessed by immunohistochemistry.
Time Frame At enrollment  

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.
Tumor MIB-1 (Ki-67) rate testing was not done because it was too costly.

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.


Measured Values
   KRAS Mut 2   KRAS Mut 1   WT KRAS 1   WT KRAS 2 
Participants Analyzed   0   0   0   0 
Number of Participants With Changes in a Tumor's MIB-1 (Ki-67) Rate             

No statistical analysis provided for Number of Participants With Changes in a Tumor's MIB-1 (Ki-67) Rate



9.  Other Pre-specified:   Change in T Cell Immunoglobulin Mucin 3 (TIM-3) on Tregs   [ Time Frame: Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment) ]

Measure Type Other Pre-specified
Measure Title Change in T Cell Immunoglobulin Mucin 3 (TIM-3) on Tregs
Measure Description Fold change from cycle 1 day 1 was determined by TIM-3 expression level on Tregs measured by the median channel number of fluorescence intensity.
Time Frame Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)  

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.
These are exploratory results and a normal range has not been defined for fold change. No participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. Missing numbers in the other cohorts were either not drawn, misplaced or the samples were not viable.

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 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.


Measured Values
   KRAS Mut 2   KRAS Mut 1   WT KRAS 2 
Participants Analyzed   17   4   8 
Change in T Cell Immunoglobulin Mucin 3 (TIM-3) on Tregs 
[Units: Fold change]
Mean (Standard Deviation)
     
Cycle 1 Day 2   1.01  (0.09)   1.01  (0.12)   1.11  (0.13) 
Cycle 1 Day 14   0.98  (0.10)   0.84  (0.07)   0.96  (0.11) 

No statistical analysis provided for Change in T Cell Immunoglobulin Mucin 3 (TIM-3) on Tregs



10.  Other Pre-specified:   Change in Cytotoxic T-lymphocyte Associated Protein 4 (CTLA-4) Expression on Tregs   [ Time Frame: Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment) ]

Measure Type Other Pre-specified
Measure Title Change in Cytotoxic T-lymphocyte Associated Protein 4 (CTLA-4) Expression on Tregs
Measure Description The fold change from cycle 1 day 1 was determined by the level of CTLA-4 expression on Tregs measured by the median channel number of fluorescence intensity.
Time Frame Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)  

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.
These are exploratory results and a normal range has not been defined for fold change. No participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. Missing numbers in the other cohorts were either not drawn, misplaced or the samples were not viable.

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 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.


Measured Values
   KRAS Mut 2   KRAS Mut 1   WT KRAS 2 
Participants Analyzed   17   4   10 
Change in Cytotoxic T-lymphocyte Associated Protein 4 (CTLA-4) Expression on Tregs 
[Units: Fold change]
Mean (Standard Deviation)
     
Cycle 1 Day 2   0.95  (0.17)   0.85  (0.10)   1.15  (0.28) 
Cycle 1 Day 14   1.25  (0.46)   0.89  (0.29)   1.49  (0.61) 

No statistical analysis provided for Change in Cytotoxic T-lymphocyte Associated Protein 4 (CTLA-4) Expression on Tregs



11.  Other Pre-specified:   Change in Programmed Cell Death-1 (PD-1) Expression on Tregs   [ Time Frame: Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment) ]

Measure Type Other Pre-specified
Measure Title Change in Programmed Cell Death-1 (PD-1) Expression on Tregs
Measure Description Fold change from cycle 1 day 1 was determined by the PD-1 expression level on Tregs measured by the median channel number of fluorescence intensity.
Time Frame Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)  

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.
These are exploratory results and a normal range has not been defined for fold change. No participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. Missing numbers in the other cohorts were either not drawn, misplaced or the samples were not viable.

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 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.


Measured Values
   KRAS Mut 2   KRAS Mut 1   WT KRAS 2 
Participants Analyzed   17   4   10 
Change in Programmed Cell Death-1 (PD-1) Expression on Tregs 
[Units: Fold change]
Mean (Standard Deviation)
     
Cycle 1 Day 2   0.99  (0.28)   0.96  (0.09)   1.33  (0.57) 
Cycle 1 Day 14   1.31  (0.42)   0.98  (0.04)   2.31  (1.77) 

No statistical analysis provided for Change in Programmed Cell Death-1 (PD-1) Expression on Tregs



12.  Other Pre-specified:   Change in Programmed Cell Death-1 (PD-1) Expression on Cluster of Differentiation 8 (CD8)+T Cells   [ Time Frame: Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment) ]

Measure Type Other Pre-specified
Measure Title Change in Programmed Cell Death-1 (PD-1) Expression on Cluster of Differentiation 8 (CD8)+T Cells
Measure Description Fold change from cycle 1 day 1 was determined by programmed cell death-1 (PD-1) expression on CD8+ T cells measured by the median channel number of fluorescence intensity.
Time Frame Cycle 1 Day 1 pre-treatment with Cycle 1 Day 2 (1 day after starting treatment), and Cycle 1 Day 14 (2 weeks after starting treatment)  

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.
These are exploratory results and a normal range has not been defined for fold change. No participants were analyzed in the WT KRAS 1 cohort because no samples were available for analysis. Missing numbers in the other cohorts were either not drawn, misplaced or the samples were not viable.

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 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.


Measured Values
   KRAS Mut 2   KRAS Mut 1   WT KRAS 2 
Participants Analyzed   17   4   10 
Change in Programmed Cell Death-1 (PD-1) Expression on Cluster of Differentiation 8 (CD8)+T Cells 
[Units: Fold change]
Mean (Standard Deviation)
     
Cycel 1 Day 2   1.05  (0.15)   1.09  (0.33)   1.19  (0.40) 
Cycle 1 Day 14   1.16  (0.27)   1.14  (0.34)   1.26  (0.25) 

No statistical analysis provided for Change in Programmed Cell Death-1 (PD-1) Expression on Cluster of Differentiation 8 (CD8)+T Cells



13.  Other Pre-specified:   Phospho-ERK (p-ERK), Phospho Protein Kinase B (p-AKt) and Phosphatase and Tensin Homolog (PTEN) Expression Testing   [ Time Frame: At enrollment ]

Measure Type Other Pre-specified
Measure Title Phospho-ERK (p-ERK), Phospho Protein Kinase B (p-AKt) and Phosphatase and Tensin Homolog (PTEN) Expression Testing
Measure Description p-ERK, p-AKt and PTEN protein expression testing was to be assessed by immunohistochemistry.
Time Frame At enrollment  

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.
Zero participants were analyzed because most of the immunohistochemistry (IHC) specialty assays (e.g. IHC, fluoresense in situ hybridization (FISH), polymerase chain reaction (PCR) were not available (still are not performed in path) and required funding for development that was not provided.

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.


Measured Values
   KRAS Mut 2   KRAS Mut 1   WT KRAS 1   WT KRAS 2 
Participants Analyzed   0   0   0   0 
Phospho-ERK (p-ERK), Phospho Protein Kinase B (p-AKt) and Phosphatase and Tensin Homolog (PTEN) Expression Testing             

No statistical analysis provided for Phospho-ERK (p-ERK), Phospho Protein Kinase B (p-AKt) and Phosphatase and Tensin Homolog (PTEN) Expression Testing



14.  Other Pre-specified:   Number of Participants With Overexpression of Estimated Glomerular Filtration Rate (EGFR) and c-MET   [ Time Frame: At enrollment ]

Measure Type Other Pre-specified
Measure Title Number of Participants With Overexpression of Estimated Glomerular Filtration Rate (EGFR) and c-MET
Measure Description Number of participants with over expression of EGFR and c-MET was to be assessed by fluoresense in situ hybridization (FISH).
Time Frame At enrollment  

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.
Zero participants were analyzed because most of the immunohistochemistry (IHC) specialty assays (e.g. IHC, fluoresense in situ hybridization (FISH), polymerase chain reaction (PCR) were not available (still are not performed in path) and required funding for development that was not provided.

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) + erl (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 (every day)

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 (every day) + erl (erlotinib) mg qd.


Measured Values
   KRAS Mut 2   KRAS Mut 1   WT KRAS 1   WT KRAS 2 
Participants Analyzed   0   0   0   0 
Number of Participants With Overexpression of Estimated Glomerular Filtration Rate (EGFR) and c-MET             

No statistical analysis provided for Number of Participants With Overexpression of Estimated Glomerular Filtration Rate (EGFR) and c-MET



15.  Other Pre-specified:   Number of Participants Who Underwent Mutational Analysis for Estimated Glomerular Filtration Rate (EGFR), Mitogen-activated Protein Kinase 1 (MEK 1), Proto-oncogene B-Raf (BRAF), and LKB1   [ Time Frame: At enrollment ]

Measure Type Other Pre-specified
Measure Title Number of Participants Who Underwent Mutational Analysis for Estimated Glomerular Filtration Rate (EGFR), Mitogen-activated Protein Kinase 1 (MEK 1), Proto-oncogene B-Raf (BRAF), and LKB1
Measure Description Number of participants who underwent mutational analysis for EGFR, MEK 1, BRAF, and LKB1 was to be assessed by polymerase chain reaction (PCR).
Time Frame At enrollment  

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.
Zero participants were analyzed because most of the immunohistochemistry (IHC) specialty assays (e.g. IHC, fluoresense in situ hybridization (FISH), polymerase chain reaction (PCR) were not available (still are not performed in path) and required funding for development that was not provided.

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.


Measured Values
   KRAS Mut 2   KRAS Mut 1   WT KRAS 1   WT KRAS 2 
Participants Analyzed   0   0   0   0 
Number of Participants Who Underwent Mutational Analysis for Estimated Glomerular Filtration Rate (EGFR), Mitogen-activated Protein Kinase 1 (MEK 1), Proto-oncogene B-Raf (BRAF), and LKB1             

No statistical analysis provided for Number of Participants Who Underwent Mutational Analysis for Estimated Glomerular Filtration Rate (EGFR), Mitogen-activated Protein Kinase 1 (MEK 1), Proto-oncogene B-Raf (BRAF), and LKB1




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

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
First Submitted: October 26, 2010
First Posted: October 27, 2010
Results First Submitted: October 23, 2014
Results First Posted: October 29, 2014
Last Update Posted: May 23, 2017