Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01168973




Registration number
NCT01168973
Ethics application status
Date submitted
16/07/2010
Date registered
23/07/2010
Date last updated
25/09/2019

Titles & IDs
Public title
A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy
Scientific title
A Randomized, Double-Blind, Phase 3 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression After One Prior Platinum-Based Therapy
Secondary ID [1] 0 0
I4T-MC-JVBA
Secondary ID [2] 0 0
13852
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Ramucirumab
Treatment: Drugs - Placebo (for Ramucirumab)
Treatment: Drugs - Docetaxel

Experimental: Ramucirumab + Docetaxel -

Placebo Comparator: Placebo + Docetaxel -


Other interventions: Ramucirumab
10 milligrams per kilogram (mg/kg) administered intravenously (IV) on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met

Treatment: Drugs: Placebo (for Ramucirumab)
Administered IV on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met

Treatment: Drugs: Docetaxel
75 milligrams per square meter (mg/m^2) (60 mg/m^2 for the countries of Korea and Taiwan only with protocol amendment dated 22 May 2012) administered IV on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival
Timepoint [1] 0 0
Randomization to date of death from any cause (up to 34 months)
Secondary outcome [1] 0 0
Progression-Free Survival (PFS) Time
Timepoint [1] 0 0
Randomization to measured PD or date of death from any cause (up to 29 months)
Secondary outcome [2] 0 0
Percentage of Participants Achieving an Objective Response (Objective Response Rate)
Timepoint [2] 0 0
Baseline to measured PD (up to 29 months)
Secondary outcome [3] 0 0
Percentage of Participants Achieving Disease Control (Disease Control Rate)
Timepoint [3] 0 0
Baseline to measured PD (up to 29 months)
Secondary outcome [4] 0 0
Maximum Improvement on Lung Cancer Symptom Scale (LCSS)
Timepoint [4] 0 0
Baseline, Day 21 of each cycle, and 30 days following last infusion (up to Cycle 38, 21 days/cycle)
Secondary outcome [5] 0 0
Change From Baseline to 30-Day Follow-Up Visit on European Quality of Life Questionnaire-5 Dimension (EQ-5D) Health State Scores
Timepoint [5] 0 0
Baseline, 30 days following last infusion (up to Cycle 38, 21 days/cycle)
Secondary outcome [6] 0 0
Maximum and Minimum Serum Concentrations (Cmax and Cmin) of Ramucirumab
Timepoint [6] 0 0
Prior to infusion and 1 hour following infusion for 4 and 8 (cycles 3 and 5 at 21 days/cycle)
Secondary outcome [7] 0 0
Number of Participants With Anti-Ramucirumab Antibodies
Timepoint [7] 0 0
Baseline, prior to infusion for week 4 and 8 (cycles 3 and 5), and 30 days following last infusion (up to Cycle 38, 21 days/cycle)

Eligibility
Key inclusion criteria
- Disease progression during or after one prior first-line platinum-based chemotherapy
with or without maintenance therapy

- Prior bevacizumab as first-line and/or maintenance therapy is allowed

- Signed informed consent

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

- Histologically or cytologically confirmed NSCLC

- Stage IV NSCLC disease

- Participants have measurable or nonmeasurable disease

- Adequate organ function, defined as:

- Total bilirubin less than or equal to Upper Limit of Normal (ULN),

- Aspartate Aminotransferase (AST) and Alanine Aminotransaminase (ALT) less than or
equal to 2.5 x ULN, or less than or equal to 5 x ULN if the transferase elevation
is due to liver metastases,

- Serum creatinine less than or equal to 1.5 x ULN or calculated creatinine
clearance greater than or equal to 50 milliliters per minute (ml/min) (per the
Cockcroft-Gault formula or equivalent and/or 24-hour urine collection),

- Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 10^3/microliters
(µL), hemoglobin greater than or equal to 10.0 grams/deciliter (g/dL), and
platelets greater than or equal to 100 x 10^3/µL,

- Adequate coagulation function as defined by International Normalized Ratio (INR)
less than or equal to 1.5, or prothrombin time and partial thromboplastin time
less than or equal to 1.5 x ULN.

- The participant does not have cirrhosis at a level of Child-Pugh B (or worse) or
cirrhosis (any degree) and a history of hepatic encephalopathy or clinically
meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is
defined as ascites resulting from cirrhosis and requiring ongoing treatment with
diuretics and/or paracentesis.

- Urinary protein is less than or equal to 1+ on dipstick or routine urinalysis. If
urine dipstick or routine analysis indicates proteinuria greater than or equal to 2+,
a 24-hour urine must be collected and must demonstrate less than 1000 milligrams (mg)
of protein.

- Participants of reproductive potential (both sexes) must agree to use reliable method
of birth control (hormonal or barrier methods) during the study period and at least 12
weeks after the last dose of study therapy

- Life expectancy of greater than or equal to 3 months

- Prior radiation therapy is allowed if: In the case of chest radiotherapy at least 28
days have elapsed from the completion of radiation treatment prior to randomization;
In the case of focal or palliative radiation treatment at least 7 days have elapsed
from last radiation treatment prior to randomization (and provided that 25% or less of
total bone marrow had been irradiated); In the case of Central Nervous System (CNS)
radiation at least 14 days have elapsed from the completion of radiation treatment
prior to randomization
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Disease progression on more than 1 prior chemotherapy regimens

- Participants whose only prior treatment was a tyrosine kinase inhibitor

- The participant's tumor wholly or partially contains small cell lung cancer

- Major surgery within 28 days prior to randomization, or subcutaneous venous access
device placement within 7 days prior to randomization. Postoperative bleeding
complications or wound complications from a surgical procedure performed in the last 2
months.

- Concurrent treatment with other anticancer therapy, including other chemotherapy,
immunotherapy, hormonal therapy, chemoembolization, or targeted therapy

- Last dose of bevacizumab must be at least 28 days from time of randomization

- Last dose of cytotoxic chemotherapy must be at least 14 days from time of
randomization

- The participant has untreated CNS metastases. Participants with treated brain
metastases are eligible if they are clinically stable with regard to neurologic
function, off steroids after cranial irradiation ending at least 2 weeks prior to
randomization, or after surgical resection performed at least 28 days prior to
randomization. No evidence of Grade greater than or equal to 1 CNS hemorrhage based on
pretreatment Magnetic Resonance Imaging (MRI) or IV contrast Computed Tomography (CT)
scan.

- Radiologically documented evidence of major blood vessel invasion or encasement by
cancer

- Radiographic evidence of intratumor cavitation

- History of uncontrolled hereditary or acquired thrombotic disorder

- Chronic therapy with nonsteroidal anti-inflammatory drug (NSAIDs) or other
antiplatelet agents; Aspirin use at doses up to 325 milligrams per day (mg/day) is
permitted

- History of gross hemoptysis (defined as bright red blood or greater than or equal to
1/2 teaspoon) within 2 months prior to randomization

- Clinically relevant congestive heart failure [New York Heart Association (NYHA II-IV)]
or symptomatic or poorly controlled cardiac arrhythmia

- Any arterial thrombotic event, including myocardial infarction, unstable angina,
cerebrovascular accident, or transient ischemic attack, within 6 months prior to
randomization

- Uncontrolled arterial hypertension greater than or equal to 150 / greater than or
equal to 90 millimeters of mercury (mm Hg) despite standard medical management

- Serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to
randomization

- Significant bleeding disorders, vasculitis, or Grade 3/4 gastrointestinal bleeding
within 3 months prior to randomization

- Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to
randomization

- Bowel obstruction, history or presence of inflammatory enteropathy or extensive
intestinal resection Crohn's disease, ulcerative colitis, or chronic diarrhea

- Peripheral neuropathy greater than or equal to Grade 2 [National Cancer Institute
Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.02]

- Serious illness or medical condition(s) including, but not limited to: Human
immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome
(AIDS)-related illness; Active or uncontrolled clinically serious infection; Severe
acute or chronic medical or psychiatric condition or laboratory abnormality that may
increase the risk associated with study participation or study drug administration

- Known allergy or hypersensitivity reaction to any of the treatment components

- The participant is pregnant or breastfeeding

- Current or recent (within 28 days prior to randomization) treatment with an
investigational drug or device that has not received regulatory approval for any
indication at the time of randomization, or participation in another interventional
clinical trial

- Prior therapy with docetaxel

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2016
Sample size
Target
Accrual to date
Final
1253
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Montana
Country [20] 0 0
United States of America
State/province [20] 0 0
Nevada
Country [21] 0 0
United States of America
State/province [21] 0 0
New Hampshire
Country [22] 0 0
United States of America
State/province [22] 0 0
New Mexico
Country [23] 0 0
United States of America
State/province [23] 0 0
New York
Country [24] 0 0
United States of America
State/province [24] 0 0
North Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
North Dakota
Country [26] 0 0
United States of America
State/province [26] 0 0
Ohio
Country [27] 0 0
United States of America
State/province [27] 0 0
Oklahoma
Country [28] 0 0
United States of America
State/province [28] 0 0
Pennsylvania
Country [29] 0 0
United States of America
State/province [29] 0 0
South Carolina
Country [30] 0 0
United States of America
State/province [30] 0 0
South Dakota
Country [31] 0 0
United States of America
State/province [31] 0 0
Tennessee
Country [32] 0 0
United States of America
State/province [32] 0 0
Texas
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Washington
Country [35] 0 0
United States of America
State/province [35] 0 0
Wisconsin
Country [36] 0 0
Argentina
State/province [36] 0 0
Buenos Aires
Country [37] 0 0
Argentina
State/province [37] 0 0
Córdoba
Country [38] 0 0
Argentina
State/province [38] 0 0
La Rioja
Country [39] 0 0
Argentina
State/province [39] 0 0
Rosario
Country [40] 0 0
Argentina
State/province [40] 0 0
Tucumain
Country [41] 0 0
Argentina
State/province [41] 0 0
Viedma
Country [42] 0 0
Austria
State/province [42] 0 0
Graz
Country [43] 0 0
Austria
State/province [43] 0 0
Grimmenstein
Country [44] 0 0
Austria
State/province [44] 0 0
Vienna
Country [45] 0 0
Austria
State/province [45] 0 0
Wels
Country [46] 0 0
Brazil
State/province [46] 0 0
Barretos
Country [47] 0 0
Brazil
State/province [47] 0 0
Belo Horizonte
Country [48] 0 0
Brazil
State/province [48] 0 0
Goiania
Country [49] 0 0
Brazil
State/province [49] 0 0
Porto Alegre
Country [50] 0 0
Brazil
State/province [50] 0 0
São Paulo
Country [51] 0 0
Canada
State/province [51] 0 0
Alberta
Country [52] 0 0
Canada
State/province [52] 0 0
New Brunswick
Country [53] 0 0
Canada
State/province [53] 0 0
Quebec
Country [54] 0 0
France
State/province [54] 0 0
Grenoble
Country [55] 0 0
France
State/province [55] 0 0
Lille
Country [56] 0 0
France
State/province [56] 0 0
Lyon
Country [57] 0 0
France
State/province [57] 0 0
Nice
Country [58] 0 0
France
State/province [58] 0 0
Strasbourg
Country [59] 0 0
France
State/province [59] 0 0
Toulouse
Country [60] 0 0
France
State/province [60] 0 0
Vandoeuvre Les Nancy
Country [61] 0 0
Germany
State/province [61] 0 0
Augsburg
Country [62] 0 0
Germany
State/province [62] 0 0
Bad Soden
Country [63] 0 0
Germany
State/province [63] 0 0
Bielefeld
Country [64] 0 0
Germany
State/province [64] 0 0
Dresden
Country [65] 0 0
Germany
State/province [65] 0 0
Frankfurt
Country [66] 0 0
Germany
State/province [66] 0 0
Gerlingen
Country [67] 0 0
Germany
State/province [67] 0 0
Großhansdorf
Country [68] 0 0
Germany
State/province [68] 0 0
Halle
Country [69] 0 0
Germany
State/province [69] 0 0
Heidelberg
Country [70] 0 0
Germany
State/province [70] 0 0
Immenhausen
Country [71] 0 0
Germany
State/province [71] 0 0
Oldenburg
Country [72] 0 0
Germany
State/province [72] 0 0
Ulm
Country [73] 0 0
Germany
State/province [73] 0 0
Villingen-Schwenningen
Country [74] 0 0
Greece
State/province [74] 0 0
Athens
Country [75] 0 0
Greece
State/province [75] 0 0
Chania
Country [76] 0 0
Greece
State/province [76] 0 0
Kifissia
Country [77] 0 0
Greece
State/province [77] 0 0
Patras
Country [78] 0 0
Hungary
State/province [78] 0 0
Budapest
Country [79] 0 0
Hungary
State/province [79] 0 0
Gyula
Country [80] 0 0
Hungary
State/province [80] 0 0
Matrahaza
Country [81] 0 0
Hungary
State/province [81] 0 0
Nyiregyhaza
Country [82] 0 0
Hungary
State/province [82] 0 0
Pécs
Country [83] 0 0
Hungary
State/province [83] 0 0
Szekesfehervar
Country [84] 0 0
India
State/province [84] 0 0
Bangalore
Country [85] 0 0
India
State/province [85] 0 0
Cuttack
Country [86] 0 0
India
State/province [86] 0 0
Delhi
Country [87] 0 0
India
State/province [87] 0 0
Jaipur
Country [88] 0 0
India
State/province [88] 0 0
Kochin
Country [89] 0 0
India
State/province [89] 0 0
Madurai
Country [90] 0 0
India
State/province [90] 0 0
Mumbai
Country [91] 0 0
India
State/province [91] 0 0
Pune
Country [92] 0 0
India
State/province [92] 0 0
Trivandrum
Country [93] 0 0
Israel
State/province [93] 0 0
Haifa
Country [94] 0 0
Israel
State/province [94] 0 0
Jerusalem
Country [95] 0 0
Israel
State/province [95] 0 0
Kfar Saba
Country [96] 0 0
Israel
State/province [96] 0 0
Petah Tikva
Country [97] 0 0
Israel
State/province [97] 0 0
Safed
Country [98] 0 0
Israel
State/province [98] 0 0
Tel-Aviv
Country [99] 0 0
Italy
State/province [99] 0 0
Livorno
Country [100] 0 0
Italy
State/province [100] 0 0
Monza
Country [101] 0 0
Italy
State/province [101] 0 0
Novara
Country [102] 0 0
Italy
State/province [102] 0 0
Padova
Country [103] 0 0
Italy
State/province [103] 0 0
Palermo
Country [104] 0 0
Italy
State/province [104] 0 0
Parma
Country [105] 0 0
Italy
State/province [105] 0 0
Pisa
Country [106] 0 0
Italy
State/province [106] 0 0
Rome
Country [107] 0 0
Korea, Republic of
State/province [107] 0 0
Incheon
Country [108] 0 0
Korea, Republic of
State/province [108] 0 0
Seoul
Country [109] 0 0
Korea, Republic of
State/province [109] 0 0
Suwon-City
Country [110] 0 0
Mexico
State/province [110] 0 0
Guadalajara
Country [111] 0 0
Mexico
State/province [111] 0 0
Mexico City
Country [112] 0 0
Netherlands
State/province [112] 0 0
Amsterdam
Country [113] 0 0
Netherlands
State/province [113] 0 0
Arnhem
Country [114] 0 0
Netherlands
State/province [114] 0 0
Harderwijk
Country [115] 0 0
Netherlands
State/province [115] 0 0
S-Hertogenbosch
Country [116] 0 0
Netherlands
State/province [116] 0 0
Zwolle
Country [117] 0 0
New Zealand
State/province [117] 0 0
Grafton
Country [118] 0 0
New Zealand
State/province [118] 0 0
Wellington
Country [119] 0 0
Norway
State/province [119] 0 0
Oslo
Country [120] 0 0
Norway
State/province [120] 0 0
Tromsø
Country [121] 0 0
Poland
State/province [121] 0 0
Gdansk
Country [122] 0 0
Poland
State/province [122] 0 0
Gdynia
Country [123] 0 0
Poland
State/province [123] 0 0
Glucholazy
Country [124] 0 0
Poland
State/province [124] 0 0
Krakow
Country [125] 0 0
Poland
State/province [125] 0 0
Lodz
Country [126] 0 0
Poland
State/province [126] 0 0
Opole
Country [127] 0 0
Poland
State/province [127] 0 0
Otwock
Country [128] 0 0
Poland
State/province [128] 0 0
Poznan
Country [129] 0 0
Puerto Rico
State/province [129] 0 0
Bayamon
Country [130] 0 0
Romania
State/province [130] 0 0
Bucharest
Country [131] 0 0
Romania
State/province [131] 0 0
Cluj-Napoca
Country [132] 0 0
Romania
State/province [132] 0 0
Iasi
Country [133] 0 0
Russian Federation
State/province [133] 0 0
Moscow
Country [134] 0 0
Russian Federation
State/province [134] 0 0
Saint Petersburg
Country [135] 0 0
Russian Federation
State/province [135] 0 0
Stavropol
Country [136] 0 0
Spain
State/province [136] 0 0
Barcelona
Country [137] 0 0
Spain
State/province [137] 0 0
Girona
Country [138] 0 0
Spain
State/province [138] 0 0
Las Palmas De Gran Canaria
Country [139] 0 0
Spain
State/province [139] 0 0
Madrid
Country [140] 0 0
Spain
State/province [140] 0 0
Mataró
Country [141] 0 0
Spain
State/province [141] 0 0
Pamplona
Country [142] 0 0
Spain
State/province [142] 0 0
Pozuelo De Alarcon
Country [143] 0 0
Sweden
State/province [143] 0 0
Eskilstuna
Country [144] 0 0
Sweden
State/province [144] 0 0
Linkoping
Country [145] 0 0
Sweden
State/province [145] 0 0
Lund
Country [146] 0 0
Sweden
State/province [146] 0 0
Solna
Country [147] 0 0
Switzerland
State/province [147] 0 0
Basel
Country [148] 0 0
Switzerland
State/province [148] 0 0
Bern
Country [149] 0 0
Switzerland
State/province [149] 0 0
Fribourg
Country [150] 0 0
Switzerland
State/province [150] 0 0
Luzern
Country [151] 0 0
Switzerland
State/province [151] 0 0
Zurich
Country [152] 0 0
Taiwan
State/province [152] 0 0
Kaohsiung
Country [153] 0 0
Taiwan
State/province [153] 0 0
Kuei Shan Hsiang
Country [154] 0 0
Taiwan
State/province [154] 0 0
Neihu Taipei
Country [155] 0 0
Taiwan
State/province [155] 0 0
Niao Sung Hsiang
Country [156] 0 0
Taiwan
State/province [156] 0 0
Taichung
Country [157] 0 0
Taiwan
State/province [157] 0 0
Taipei
Country [158] 0 0
Turkey
State/province [158] 0 0
Ankara
Country [159] 0 0
Turkey
State/province [159] 0 0
Istanbul
Country [160] 0 0
Turkey
State/province [160] 0 0
Izmir
Country [161] 0 0
Turkey
State/province [161] 0 0
Kayseri
Country [162] 0 0
United Kingdom
State/province [162] 0 0
East Yorkshire
Country [163] 0 0
United Kingdom
State/province [163] 0 0
Greater London
Country [164] 0 0
United Kingdom
State/province [164] 0 0
Lancashire
Country [165] 0 0
United Kingdom
State/province [165] 0 0
Manchester
Country [166] 0 0
United Kingdom
State/province [166] 0 0
North Lincolnshire
Country [167] 0 0
United Kingdom
State/province [167] 0 0
Scotland
Country [168] 0 0
United Kingdom
State/province [168] 0 0
West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to compare the survival of participants who receive chemotherapy
and ramucirumab versus chemotherapy alone as second line treatment for NSCLC after prior
first line platinum-based chemotherapy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01168973
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01168973