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Trial record 54 of 78 for:    vismodegib

GDC-0449 in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT00980343
Recruitment Status : Completed
First Posted : September 21, 2009
Results First Posted : August 16, 2017
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Giant Cell Glioblastoma
Adult Glioblastoma
Adult Gliosarcoma
Recurrent Adult Brain Tumor
Interventions Drug: vismodegib
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Other: pharmacological study
Enrollment 44
Recruitment Details Subjects were enrolled from March 2010 to April 2011. Subjects were recruited from outpatient cancer centers but all patients needed surgery to participate in this study.
Pre-assignment Details  
Arm/Group Title Arm I (Pre-surgery Vismodegib) Arm II (no Vismodegib Pre-surgery)
Hide Arm/Group Description

Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study; laboratory biomarker analysis

vismodegib: Given orally

therapeutic conventional surgery: undergo surgery

laboratory biomarker analysis: correlative studies

pharmacological study: correlative studies

Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis

vismodegib: Given orally

therapeutic conventional surgery: undergo surgery

laboratory biomarker analysis: correlative studies

Period Title: Overall Study
Started 21 23
Completed 20 20
Not Completed 1 3
Reason Not Completed
no tumor at surgery - treatment effect             1             3
Arm/Group Title Arm I (Pre-surgery Vismodegib) Arm II (no Vismodegib Pre-surgery) Total
Hide Arm/Group Description

Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study; laboratory biomarker analysis

vismodegib: Given orally

therapeutic conventional surgery: undergo surgery

laboratory biomarker analysis: correlative studies

pharmacological study: correlative studies

Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis

vismodegib: Given orally

therapeutic conventional surgery: undergo surgery

laboratory biomarker analysis: correlative studies

Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
40 patients were evaluable for toxicities, demographics but only 39 for tissue evaluation
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
57
(42 to 79)
60
(37 to 74)
59
(37 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
11
  55.0%
10
  50.0%
21
  52.5%
Male
9
  45.0%
10
  50.0%
19
  47.5%
Karnofsky Performance Status Scale   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 20 participants 40 participants
80
(60 to 100)
90
(60 to 100)
80
(60 to 100)
[1]
Measure Description: Higher score better 100 normal no complaints/disease 90 capable normal activity few symptoms/disease 80 normal activity, some difficulty some symptoms/signs 70 caring for self not capable normal activity/work 60 requiring some help can take care of most personal requirements 50 requires help often requires frequent medical care 40 disabled requires special care/help 30 severely disabled hospital admission indicated but no risk of death 20 very ill urgently requiring admission requires supportive measures/treatment 10 moribund rapidly progressive fatal disease processes 0 death
Mini Mental State Exam (MMSE)   [1] 
Median (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 20 participants 40 participants
28
(16 to 30)
29
(16 to 30)
28
(16 to 30)
[1]
Measure Description: The higher the score the better Range 30 to 0
Measurable disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Yes 18 18 36
No 2 2 4
Number of Prior Treatments  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
1 Prior Treatment 12 15 27
2 Prior Treatments 6 5 11
4 Prior Treatments 2 0 2
1.Primary Outcome
Title 6 Months Progression-free Survival (PFS)
Hide Description Estimated using Kaplan Meier curves. six months calculated from date of treatment onset post-operatively. MRI scan at 6 months must be free of progression Progressive disease Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Pre-surgery Vismodegib) Arm II (no Vismodegib Pre-surgery)
Hide Arm/Group Description:

Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study; laboratory biomarker analysis

vismodegib: Given orally

therapeutic conventional surgery: undergo surgery

laboratory biomarker analysis: correlative studies

pharmacological study: correlative studies

Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis

vismodegib: Given orally

therapeutic conventional surgery: undergo surgery

laboratory biomarker analysis: correlative studies

Overall Number of Participants Analyzed 20 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
0
(0 to 16.8)
5
(0.1 to 24.9)
2.Secondary Outcome
Title Overall Survival Time
Hide Description The overall failure rate will be estimated along with 95% confidence intervals. A median time of survival will be estimated using standard methods.. Start date based on onset of treatment.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1(Pre-surgery Vismodegib) Arm II (no Vismodegib Pre-surgery)
Hide Arm/Group Description:

Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery.

Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis

vismodegib: Given orally

therapeutic conventional surgery: undergo surgery

laboratory biomarker analysis: correlative studies

Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis

vismodegib: Given orally

therapeutic conventional surgery: undergo surgery

laboratory biomarker analysis: correlative studies

Overall Number of Participants Analyzed 20 20
Median (95% Confidence Interval)
Unit of Measure: months
7.8
(3.7 to 10.2)
7.6
(5.0 to 13.1)
3.Secondary Outcome
Title Best Tumor Response Assessed by the Modified Macdonald Radiographic Response Criteria
Hide Description

The Macdonald criteria, roughly similarly to other systems, divides response into 4 types of response based on imaging (MRI) and clinical features

1: complete response; 2: partial response; 3:stable disease; 4:progression

Complete response imaging features: disappearance of all enhancing disease (measurable and non-measurable) sustained for at least 4 weeks; no new lesions clinical features; no corticosteroids; clinically stable or improved

Partial response imaging features: 50% or more decrease of all measurable enhancing lesions sustained for at least 4 weeks: no new lesions clinical features: stable or reduced corticosteroids; clinically stable or improved

Stable disease imaging features: does not qualify for complete response, partial response or progression clinical features: clinically stable

Progression imaging features: 25% of more increase in enhancing lesions; any new lesions clinical features: clinical deterioration

Time Frame evaluated every 8 weeks - 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
3 subjects not evaluable for radiographic response Arm 1 and 4 subjects not evaluable for radiographic response in Arm 2
Arm/Group Title Arm I (Pre-surgery Vismodegib) Arm II (no Vismodegib Pre-surgery)
Hide Arm/Group Description:

Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study; laboratory biomarker analysis

vismodegib: Given orally

therapeutic conventional surgery: undergo surgery

laboratory biomarker analysis: correlative studies

pharmacological study: correlative studies

Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis

vismodegib: Given orally

therapeutic conventional surgery: undergo surgery

laboratory biomarker analysis: correlative studies

Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
Progressive Disease Number Analyzed 17 participants 16 participants
13 11
Stable Disease Number Analyzed 20 participants 20 participants
4 5
4.Secondary Outcome
Title Toxicity Incidence Grade 3 or 4 According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0
Hide Description NCI CTCAE grade 3 or 4 possible, probable or definitely related events Grade 3 - severe Grade 4 - life threatening
Time Frame 30 days from last dose of drug treatment - 1.5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Pre-surgery Vismodegib) Arm II (no Vismodegib Pre-surgery)
Hide Arm/Group Description:

Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study; laboratory biomarker analysis

vismodegib: Given orally

therapeutic conventional surgery: undergo surgery

laboratory biomarker analysis: correlative studies

pharmacological study: correlative studies

Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis

vismodegib: Given orally

therapeutic conventional surgery: undergo surgery

laboratory biomarker analysis: correlative studies

Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: percent of participants
Lymphocyte count decrase gr3 10 0
Stroke gr3 5 0
abdominal infection gr3 5 0
abdominal pain gr3 5 0
atrial flutter gr3 5 0
5.Secondary Outcome
Title Incidence of CD133+ Neurospheres by Arm
Hide Description number of tumor-derived CD133 neurospheres undergoing proliferation and self-renewal
Time Frame 12 hours post-vismodegib administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Pre-surgery Vismodegib) Arm II (no Vismodegib Pre-surgery)
Hide Arm/Group Description:

Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study; laboratory biomarker analysis

vismodegib: Given orally

therapeutic conventional surgery: undergo surgery

laboratory biomarker analysis: correlative studies

pharmacological study: correlative studies

Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis

vismodegib: Given orally

therapeutic conventional surgery: undergo surgery

laboratory biomarker analysis: correlative studies

Overall Number of Participants Analyzed 20 19
Measure Type: Number
Unit of Measure: percent of CD133 Neuospheres
3 11
6.Secondary Outcome
Title Changes in Sonic Hedgehog Pathway Activation
Hide Description determined by Reverse transcription polymerase chain reaction (RT-PCR) and immunohistochemistry (IHC) (Gli-1, Gli-2, PATCH (PTCH-1b)
Time Frame Pre-tumor resection and post tumor resection (12 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
only small number of samples and thus not enough to give useful information. Samples not processed for outcome and analysis was not performed. No numerical data to report
Arm/Group Title Arm 1(Pre-surgery Vismodegib) Arm II (no Vismodegib Pre-surgery)
Hide Arm/Group Description:

Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery.

Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis

vismodegib: Given orally

therapeutic conventional surgery: undergo surgery

laboratory biomarker analysis: correlative studies

Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis

vismodegib: Given orally

therapeutic conventional surgery: undergo surgery

laboratory biomarker analysis: correlative studies

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Determine Drug Effect (Pharmacokinetics) in Plasma for Arm 1
Hide Description samples collected pre tumor resection (day of surgery) and post-tumor resection (day of surgery
Time Frame Day of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1(Pre-surgery Vismodegib)
Hide Arm/Group Description:

Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery.

Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis

vismodegib: Given orally

therapeutic conventional surgery: undergo surgery

laboratory biomarker analysis: correlative studies

Overall Number of Participants Analyzed 20
Median (Standard Deviation)
Unit of Measure: ng/ml
Plasma 7638  (1759)
Intra-tumoral level 3270  (1326)
Time Frame 1year
Adverse Event Reporting Description patients were treated pre and post surgery
 
Arm/Group Title Arm I (Pre-surgery Vismodegib) Arm II (no Vismodegib Pre-surgery)
Hide Arm/Group Description

Patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily for 7 days before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: pharmacological study; laboratory biomarker analysis

vismodegib: Given orally

therapeutic conventional surgery: undergo surgery

laboratory biomarker analysis: correlative studies

pharmacological study: correlative studies

Patients do not receive treatment before therapeutic conventional surgery. Beginning within 28 days after surgical resection, all patients receive oral Hedgehog antagonist GDC-0449 (vismodegib) once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Other: laboratory biomarker analysis

vismodegib: Given orally

therapeutic conventional surgery: undergo surgery

laboratory biomarker analysis: correlative studies

All-Cause Mortality
Arm I (Pre-surgery Vismodegib) Arm II (no Vismodegib Pre-surgery)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Pre-surgery Vismodegib) Arm II (no Vismodegib Pre-surgery)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (Pre-surgery Vismodegib) Arm II (no Vismodegib Pre-surgery)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/20 (100.00%)      20/20 (100.00%)    
Blood and lymphatic system disorders     
anemia * 1  3/20 (15.00%)  3 4/20 (20.00%)  4
Cardiac disorders     
atrial flutter * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Gastrointestinal disorders     
abdominal pain * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
constipation * 1  2/20 (10.00%)  2 3/20 (15.00%)  3
diarrhea * 1  3/20 (15.00%)  3 2/20 (10.00%)  2
gastroesophageal reflux disease * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
nausea * 1  2/20 (10.00%)  2 5/20 (25.00%)  5
General disorders     
fatigue * 1  7/20 (35.00%)  7 8/20 (40.00%)  8
non-cardiac chest pain * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Infections and infestations     
abdominal infection * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
urinary tract infection * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Investigations     
activated partial thromboplastin time prolonged * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
alanine aminotransferase increased * 1  4/20 (20.00%)  4 0/20 (0.00%)  0
aspartate aminotransferase increased * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
lymphocyte count decrease * 1  2/20 (10.00%)  2 1/20 (5.00%)  1
neutrophile count decrease * 1  1/20 (5.00%)  1 3/20 (15.00%)  3
platelet count decrease * 1  3/20 (15.00%)  3 1/20 (5.00%)  1
white blood cell decrease * 1  2/20 (10.00%)  2 4/20 (20.00%)  4
Metabolism and nutrition disorders     
anorexia * 1  4/20 (20.00%)  4 5/20 (25.00%)  5
hypocalcemia * 1  1/20 (5.00%)  1 1/20 (5.00%)  1
hypokalemia * 1  1/20 (5.00%)  1 1/20 (5.00%)  1
hyperglycemia * 1  0/20 (0.00%)  0 2/20 (10.00%)  2
hypermagnesemia * 1  0/20 (0.00%)  0 4/20 (20.00%)  4
hypophosphatemia * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders     
back pain * 1  1/20 (5.00%)  1 1/20 (5.00%)  1
musculoskeletal and connective tissue disorder * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Muscle weakness * 1 [1]  1/20 (5.00%)  1 0/20 (0.00%)  0
myalgia * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Nervous system disorders     
dysgeusia * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
dysphasia * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
dizziness * 1  0/20 (0.00%)  0 2/20 (10.00%)  2
facial muscle weakness * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
headache * 1  1/20 (5.00%)  1 3/20 (15.00%)  3
stroke * 1  1/20 (5.00%)  1 0/20 (0.00%)  0
Psychiatric disorders     
insomnia * 1  1/20 (5.00%)  1 1/20 (5.00%)  1
Renal and urinary disorders     
hematuria * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Proteinuria * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
urine discoloration * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
Skin and subcutaneous tissue disorders     
alopecia * 1  0/20 (0.00%)  0 2/20 (10.00%)  2
dry skin * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
pain of skin * 1  0/20 (0.00%)  0 1/20 (5.00%)  1
rash acneiform * 1  1/20 (5.00%)  1 1/20 (5.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
left side
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Charles J Nock, MD
Organization: Adult Brain Tumor Consortium (ABTC)
Phone: 410-955-8837
EMail: jfisher@jhmi.edu
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00980343     History of Changes
Other Study ID Numbers: NCI-2012-02922
NCI-2012-02922 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000654829
ABTC-0904 ( Other Identifier: Adult Brain Tumor Consortium )
ABTC-0904 ( Other Identifier: CTEP )
U01CA137443 ( U.S. NIH Grant/Contract )
First Submitted: September 18, 2009
First Posted: September 21, 2009
Results First Submitted: October 27, 2016
Results First Posted: August 16, 2017
Last Update Posted: August 16, 2017