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Chemotherapy for Patients With Non-Small Cell Lung Cancer Who Are Non-Smokers

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ClinicalTrials.gov Identifier: NCT00409006
Recruitment Status : Completed
First Posted : December 8, 2006
Results First Posted : September 9, 2010
Last Update Posted : September 9, 2010
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Non-small Cell Lung Cancer
Interventions Drug: Pemetrexed
Drug: Cisplatin
Drug: Gefitinib
Enrollment 70
Recruitment Details  
Pre-assignment Details 86 participants entered study. 13 participants were screen failures. 73 participants (40 pemetrexed/cisplatin/gefitinib and 33 pemetrexed/cisplatin) were assigned to treatment. 3 participants did not receive study drug. These 16 participants (13 screen failures and 3 that did not receive drug) were not included in the analyses.
Arm/Group Title Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
Hide Arm/Group Description Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity. Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
Period Title: Overall Study
Started 39 31
Completed 19 19
Not Completed 20 12
Reason Not Completed
Death             15             6
Lost to Follow-up             1             2
Withdrawal by Subject             3             2
Physician Decision             1             2
Arm/Group Title Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin Total
Hide Arm/Group Description Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity. Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 39 31 70
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 31 participants 70 participants
55.6  (8.45) 55.7  (12.43) 55.7  (10.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 31 participants 70 participants
Female
30
  76.9%
25
  80.6%
55
  78.6%
Male
9
  23.1%
6
  19.4%
15
  21.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
East Asian Number Analyzed 39 participants 31 participants 70 participants
39 31 70
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 31 participants 70 participants
Taiwan 10 11 21
China 16 14 30
Korea, Republic of 13 6 19
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Units on a scale
Number Analyzed 39 participants 31 participants 70 participants
0 15 9 24
1 24 22 46
[1]
Measure Description: Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). 0 - Fully Active. 1 - Ambulatory, Restricted Strenuous Activity. 2 - Ambulatory, No Work Activities. 3 - Partially Confined to Bed, Limited Self Care. 4 - Completely Disabled.
History of Smoking  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 31 participants 70 participants
Yes 0 2 2
No 39 29 68
Basis of Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 31 participants 70 participants
Histopathological 30 22 52
Cytological 9 9 18
Pathological Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 31 participants 70 participants
Mixed Cell Carcinoma, Lung 1 1 2
Adenocarcinoma 30 24 54
Carcinoma, Squamous Cell 7 4 11
Non-Small Cell Lung Carcinoma 1 2 3
Disease Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 31 participants 70 participants
Stage IIIB 6 4 10
Stage IV 33 27 60
[1]
Measure Description: Stage means how big the tumor is and how far it has spread. Stages range from 0 (not spread) to IV (spread throughout the body). Stage 0 - the cancer has not spread beyond the inner lining of the lung. Stage I - the cancer is small and hasn't spread to the lymph nodes. Stage II - the cancer has spread to some lymph nodes near the original tumor. Stage III - the cancer has spread to nearby tissue or spread to far away lymph nodes. Stage IV - the cancer has spread to other organs of the body such as the other lung, brain, or liver.
1.Primary Outcome
Title Progression-Free Survival (PFS)
Hide Description Defined as the time from randomization to the first observation of disease progression, or death due to any cause.
Time Frame Baseline to first observation of disease progression or death, 12 weeks up to 31 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized and treated (RT) population includes all randomized patients. Patients are analyzed according to the treatment they actually received (intent-to-treat [ITT] analysis). Patients were censored from this analysis (8 pemetrexed/cisplatin/gefitinib and 11 pemetrexed/cisplatin).
Arm/Group Title Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
Hide Arm/Group Description:
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 39 31
Median (95% Confidence Interval)
Unit of Measure: Months
9.95
(5.85 to 16.49)
6.83
(5.78 to 7.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed/Cisplatin/Gefitinib, Pemetrexed/Cisplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0618
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Number of Participants With Tumor Response
Hide Description Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes not meeting above criteria. Responder is a participant exhibiting a best overall study response of CR or PR.
Time Frame Baseline to measured response or death, 12 weeks up to 31 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Qualified for Response population includes all treated patients with measurable disease prior first dose of study therapy.
Arm/Group Title Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
Hide Arm/Group Description:
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 39 31
Measure Type: Number
Unit of Measure: Participants
18 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pemetrexed/Cisplatin/Gefitinib, Pemetrexed/Cisplatin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.369
Comments [Not Specified]
Method Regression, Logistic
Comments Used the Wald Chi-squared statistic from a logistic regression analysis.
3.Secondary Outcome
Title Duration of Response for Responders
Hide Description The duration of a complete response (CR; the disappearance of all target lesions) or partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause. A responder is a patient exhibiting a best overall study response of CR or PR.
Time Frame Time of response to progressive disease or death, 12 weeks up to 31 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Qualified for Response population includes all treated patients with measurable disease prior first dose of study therapy. Patients were censored for this analysis (2 pemetrexed/cisplatin/gefitinib and 2 pemetrexed/cisplatin).
Arm/Group Title Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
Hide Arm/Group Description:
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 18 11
Median (95% Confidence Interval)
Unit of Measure: Months
12.29
(8.51 to 15.31)
4.14
(2.76 to 7.62)
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact. Median overall survival could not be estimated as most participants were living at the end of the study. 25 participants from each treatment group were censored. In place of this outcome measure, the percentage of participants who died during the study are provided in the Post-Hoc Analysis Outcome Measure: Percentage of Participants Who Died During the Study.
Time Frame Baseline to date of death from any cause, 12 weeks up to 31 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized and treated population includes all randomized patients. Patients are analyzed according to the treatment they actually received (ITT population). Median overall survival could not be estimated as most participants were living at the end of the study.
Arm/Group Title Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
Hide Arm/Group Description:
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Post-Hoc Outcome
Title Percentage of Participants Who Died During the Study
Hide Description This outcome measure takes the place of the outcome measure for Overall Survival, which could not be reported since the median value could not be calculated.
Time Frame Baseline up to 31 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Randomized and treated population includes all randomized patients. Patients are analyzed according to the treatment they actually received (ITT population). 25 participants from each treatment group were censored.
Arm/Group Title Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
Hide Arm/Group Description:
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 39 31
Measure Type: Number
Unit of Measure: Percentage of Participants
35.9 19.4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
Hide Arm/Group Description Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity. Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
All-Cause Mortality
Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/39 (15.38%)      3/31 (9.68%)    
Gastrointestinal disorders     
Nausea  1  1/39 (2.56%)  1 1/31 (3.23%)  1
Vomiting  1  1/39 (2.56%)  2 1/31 (3.23%)  1
General disorders     
Death  1  1/39 (2.56%)  1 0/31 (0.00%)  0
Pyrexia  1  1/39 (2.56%)  1 0/31 (0.00%)  0
Infections and infestations     
Acute tonsillitis  1  1/39 (2.56%)  1 0/31 (0.00%)  0
Infection  1  0/39 (0.00%)  0 1/31 (3.23%)  1
Metabolism and nutrition disorders     
Anorexia  1  1/39 (2.56%)  1 0/31 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Myalgia  1  1/39 (2.56%)  1 0/31 (0.00%)  0
Nervous system disorders     
Coma  1  1/39 (2.56%)  1 0/31 (0.00%)  0
Headache  1  1/39 (2.56%)  2 1/31 (3.23%)  1
Psychiatric disorders     
Depressed mood  1  1/39 (2.56%)  1 0/31 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Apnoeic attack  1  1/39 (2.56%)  1 0/31 (0.00%)  0
Asthma  1  0/39 (0.00%)  0 1/31 (3.23%)  1
Cough  1  1/39 (2.56%)  1 0/31 (0.00%)  0
Oropharyngeal pain  1  1/39 (2.56%)  1 0/31 (0.00%)  0
Pleural effusion  1  1/39 (2.56%)  1 0/31 (0.00%)  0
Pneumonitis  1  0/39 (0.00%)  0 1/31 (3.23%)  1
Productive cough  1  1/39 (2.56%)  1 0/31 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pemetrexed/Cisplatin/Gefitinib Pemetrexed/Cisplatin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/39 (97.44%)      31/31 (100.00%)    
Blood and lymphatic system disorders     
Anaemia  1  2/39 (5.13%)  2 0/31 (0.00%)  0
Neutropenia  1  5/39 (12.82%)  12 3/31 (9.68%)  5
Eye disorders     
Dry eye  1  2/39 (5.13%)  2 0/31 (0.00%)  0
Vision blurred  1  2/39 (5.13%)  2 1/31 (3.23%)  1
Gastrointestinal disorders     
Abdominal discomfort  1  1/39 (2.56%)  1 2/31 (6.45%)  2
Abdominal distension  1  3/39 (7.69%)  3 0/31 (0.00%)  0
Abdominal pain  1  2/39 (5.13%)  3 2/31 (6.45%)  2
Abdominal pain upper  1  2/39 (5.13%)  2 3/31 (9.68%)  3
Constipation  1  7/39 (17.95%)  12 5/31 (16.13%)  7
Diarrhoea  1  10/39 (25.64%)  14 3/31 (9.68%)  5
Dyspepsia  1  6/39 (15.38%)  7 2/31 (6.45%)  2
Nausea  1  27/39 (69.23%)  63 20/31 (64.52%)  45
Stomatitis  1  8/39 (20.51%)  13 1/31 (3.23%)  1
Toothache  1  5/39 (12.82%)  5 0/31 (0.00%)  0
Vomiting  1  19/39 (48.72%)  52 15/31 (48.39%)  29
General disorders     
Asthenia  1  3/39 (7.69%)  5 1/31 (3.23%)  1
Chest discomfort  1  1/39 (2.56%)  2 2/31 (6.45%)  2
Chest pain  1  4/39 (10.26%)  4 3/31 (9.68%)  7
Fatigue  1  10/39 (25.64%)  20 5/31 (16.13%)  9
Malaise  1  2/39 (5.13%)  2 0/31 (0.00%)  0
Mucosal inflammation  1  2/39 (5.13%)  3 3/31 (9.68%)  3
Oedema peripheral  1  2/39 (5.13%)  2 1/31 (3.23%)  1
Pyrexia  1  4/39 (10.26%)  4 1/31 (3.23%)  1
Infections and infestations     
Cystitis  1  2/39 (5.13%)  2 0/31 (0.00%)  0
Empyema  1  2/39 (5.13%)  2 0/31 (0.00%)  0
Paronychia  1  4/39 (10.26%)  5 0/31 (0.00%)  0
Rhinitis  1  4/39 (10.26%)  6 0/31 (0.00%)  0
Upper respiratory tract infection  1  3/39 (7.69%)  4 0/31 (0.00%)  0
Investigations     
Alanine aminotransferase increased  1  5/39 (12.82%)  6 6/31 (19.35%)  11
Aspartate aminotransferase increased  1  5/39 (12.82%)  6 6/31 (19.35%)  7
Creatinine renal clearance decreased  1  3/39 (7.69%)  3 4/31 (12.90%)  8
Haemoglobin decreased  1  8/39 (20.51%)  8 11/31 (35.48%)  12
Neutrophil count decreased  1  8/39 (20.51%)  14 13/31 (41.94%)  26
Weight decreased  1  2/39 (5.13%)  2 0/31 (0.00%)  0
White blood cell count decreased  1  6/39 (15.38%)  9 8/31 (25.81%)  14
Metabolism and nutrition disorders     
Anorexia  1  19/39 (48.72%)  35 15/31 (48.39%)  24
Decreased appetite  1  0/39 (0.00%)  0 2/31 (6.45%)  2
Hyperglycaemia  1  2/39 (5.13%)  2 1/31 (3.23%)  1
Hyperkalaemia  1  0/39 (0.00%)  0 2/31 (6.45%)  3
Hypokalaemia  1  2/39 (5.13%)  3 0/31 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back pain  1  7/39 (17.95%)  8 1/31 (3.23%)  1
Bone pain  1  2/39 (5.13%)  2 2/31 (6.45%)  2
Musculoskeletal chest pain  1  3/39 (7.69%)  3 1/31 (3.23%)  2
Neck pain  1  2/39 (5.13%)  2 1/31 (3.23%)  1
Pain in extremity  1  3/39 (7.69%)  4 1/31 (3.23%)  2
Nervous system disorders     
Dizziness  1  6/39 (15.38%)  8 3/31 (9.68%)  4
Headache  1  4/39 (10.26%)  6 1/31 (3.23%)  1
Hypoaesthesia  1  1/39 (2.56%)  1 3/31 (9.68%)  3
Peripheral sensory neuropathy  1  6/39 (15.38%)  8 2/31 (6.45%)  2
Psychiatric disorders     
Anxiety  1  2/39 (5.13%)  2 1/31 (3.23%)  1
Depression  1  2/39 (5.13%)  3 0/31 (0.00%)  0
Insomnia  1  9/39 (23.08%)  12 4/31 (12.90%)  7
Renal and urinary disorders     
Pollakiuria  1  2/39 (5.13%)  2 0/31 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough  1  9/39 (23.08%)  11 4/31 (12.90%)  4
Dyspnoea  1  6/39 (15.38%)  8 8/31 (25.81%)  8
Oropharyngeal pain  1  3/39 (7.69%)  3 1/31 (3.23%)  1
Productive cough  1  3/39 (7.69%)  4 1/31 (3.23%)  1
Pulmonary haemorrhage  1  2/39 (5.13%)  2 0/31 (0.00%)  0
Rhinitis allergic  1  2/39 (5.13%)  2 0/31 (0.00%)  0
Skin and subcutaneous tissue disorders     
Alopecia  1  1/39 (2.56%)  2 3/31 (9.68%)  3
Dermatitis acneiform  1  3/39 (7.69%)  3 0/31 (0.00%)  0
Dry skin  1  6/39 (15.38%)  6 0/31 (0.00%)  0
Exfoliative rash  1  2/39 (5.13%)  2 1/31 (3.23%)  1
Nail disorder  1  2/39 (5.13%)  2 0/31 (0.00%)  0
Palmar-plantar erythrodysaesthesia syndrome  1  2/39 (5.13%)  2 0/31 (0.00%)  0
Pruritus  1  14/39 (35.90%)  29 5/31 (16.13%)  6
Rash  1  13/39 (33.33%)  21 6/31 (19.35%)  6
Skin exfoliation  1  4/39 (10.26%)  4 0/31 (0.00%)  0
Skin hyperpigmentation  1  2/39 (5.13%)  2 0/31 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, 12.0
Median overall survival cannot be estimated due to the high censor rate (25 participants per treatment group were censored). Most participants were still living at the end of the study.
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
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00409006     History of Changes
Other Study ID Numbers: 10918
H3E-AA-S110 ( Other Identifier: Eli Lilly and Company )
First Submitted: December 6, 2006
First Posted: December 8, 2006
Results First Submitted: August 13, 2010
Results First Posted: September 9, 2010
Last Update Posted: September 9, 2010