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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00703326




Registration number
NCT00703326
Ethics application status
Date submitted
20/06/2008
Date registered
23/06/2008

Titles & IDs
Public title
Phase III Study of Docetaxel + Ramucirumab or Placebo in Breast Cancer
Scientific title
A Multicenter, Multinational, Randomized, Double-Blind, Phase III Study of IMC-1121B Plus Docetaxel Versus Placebo Plus Docetaxel in Previously Untreated Patients With HER2-Negative, Unresectable, Locally-Recurrent or Metastatic Breast Cancer
Secondary ID [1] 0 0
2008-001727-65
Secondary ID [2] 0 0
13892
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - ramucirumab (IMC-1121B)
Treatment: Drugs - docetaxel
Other interventions - Placebo

Experimental: ramucirumab (IMC-1121B) + docetaxel -

Placebo comparator: placebo + docetaxel -


Treatment: Other: ramucirumab (IMC-1121B)
Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.

Treatment: Drugs: docetaxel
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.

Other interventions: Placebo
Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Intervention code [3] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-Free Survival (PFS)
Timepoint [1] 0 0
Randomization to disease progression or death or until data cutoff of 31 Mar 2013 (up to 56 months)
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Randomization to death or until data cutoff of 29-May-2015 (up to 82 months)
Secondary outcome [2] 0 0
Time to Progression (TTP)
Timepoint [2] 0 0
Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 56 months)
Secondary outcome [3] 0 0
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate)
Timepoint [3] 0 0
Randomization to disease progression or until data cutoff of 31-Mar-2013 (up to 56 months)
Secondary outcome [4] 0 0
Duration of Response
Timepoint [4] 0 0
Date of first CR or PR to PD or death or until data cutoff date of 31-Mar-2013 (up to 56 months)
Secondary outcome [5] 0 0
Total Functional Assessment of Cancer Therapy-Breast (FACT-B): Change From Baseline to End of Therapy
Timepoint [5] 0 0
Baseline, End of Therapy or until data cutoff of 31-Mar-2013 (up to 56 months)
Secondary outcome [6] 0 0
Number of Participants With Adverse Events
Timepoint [6] 0 0
First dose to study completion (up to 12.3 years)
Secondary outcome [7] 0 0
Immunogenicity: Percentage of Participants With Treatment Emergent Anti-Ramucirumab Antibodies Until Primary Data Cutoff of 31-Mar-2013
Timepoint [7] 0 0
Baseline, prior to cycle 3 infusion, prior to cycle 5 infusion, onset of infusion reaction, resolution of reaction and 30 days following the event up to 56 months
Secondary outcome [8] 0 0
Immunogenicity: Percentage of Participants Available After 31-Mar-2013 With Treatment Emergent Anti-Ramucirumab Antibodies Until Data Cutoff From 01-Apr-2013 to 08-Sep-2016
Timepoint [8] 0 0
Follow-up from 01-Apr-2013 to 08-Sep-2016 (Up to 56 -97 months)

Eligibility
Key inclusion criteria
* Participant is able to provide signed informed consent
* Participant is female and = 18 years of age or older if required by local laws or regulations
* Participant has histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent. Every effort should be made to make paraffin-embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis
* Participant has measurable and/or non-measurable disease
* Participants' primary and/or metastatic tumor is human epidermal growth factor receptor 2 (HER2)-negative by fluorescence in-situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) or 0, 1+ overexpression by immunohistochemistry (IHC)
* Participant has not received prior chemotherapy for metastatic or locally-recurrent and inoperable breast cancer
* Participant completed (neo) adjuvant taxane therapy at least 6 months prior to randomization
* Participant completed (neo) adjuvant biologic therapy at least 6 weeks prior to randomization
* Participant completed all prior radiotherapy with curative intent = 3 weeks prior to randomization
* Participant may have received prior hormonal therapy for breast cancer in the (neo) adjuvant and/or the metastatic setting = 2 weeks prior to randomization
* Participant's left ventricular ejection fraction is within normal institutional ranges
* Participant has resolution to grade = 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI-CTCAE v 3.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy which must have resolved to grade = 2
* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Participant is amenable to compliance with protocol schedules and testing
* Participant has adequate hematological functions [absolute neutrophil count (ANC) = 1500 cells/microliter (mcL), hemoglobin = 9 grams/deciliter (g/dL), and platelets = 100,000 cells/mcL and = 850,000 cells/mcL]
* Participant has adequate hepatic function [bilirubin within normal limits (WNL), aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 times the upper limit of normal (ULN), or = 5.0 times the ULN if the transaminase elevation is due to liver metastases, and alkaline phosphatase = 5.0 times the ULN]
* Participant has serum creatinine = 1.5 x ULN. If serum creatinine > 1.5 x ULN the calculated creatinine clearance should be > 40 milliliters/minute (mL/min)
* Participant's urinary protein is = 1+ on dipstick or routine urinalysis (UA); if urine protein = 2+, a 24-hour urine collection must demonstrate < 1000 milligrams (mg) of protein in 24 hours to allow participation in the study
* Participant must have adequate coagulation function as defined by international normalized ratio (INR) = 1.5 and a partial thromboplastin time (PTT) = 1.5 X ULN if not receiving anticoagulation therapy. Participants on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin and if on warfarin must have a INR between 2 and 3 and have no active bleeding (defined as within 14 days of randomization) or pathological condition that carries a high risk of bleeding (such as, tumor involving major vessels or known varices)
* Women of childbearing potential must implement adequate contraception in the opinion of the investigator
* Participant has not received prior biologic therapy for metastatic or locally recurrent and inoperable breast cancer
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant has a concurrent active malignancy other than breast adenocarcinoma, adequately treated non melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm. A participant with previous history of malignancy is eligible, provided that she has been disease free for > 3 years
* Participant has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80
* Participant has a known sensitivity to agents of similar biologic composition as ramucirumab or other agents that specifically target vascular endothelial growth factor (VEGF)
* Participant has a history of chronic diarrheal disease within 6 months prior to randomization
* Participant has received irradiation to a major bone marrow area as defined as > 25% of bone marrow (such as, pelvic or abdominal radiation) within 30 days prior to randomization
* Participant has participated in clinical trials of experimental agents within 4 weeks prior to randomization
* Participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
* Participant has active, high risk bleeding (such as, via gastric ulcers or gastric varices) within 14 days prior to randomization
* Participant has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy
* Participant has uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator
* Participant has brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease
* Participant has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
* Participant has pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
* Participant is pregnant or lactating

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 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
6/08/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/11/2020
Sample size
Target
Accrual to date
Final
1144
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
ImClone Investigational Site - Fitzroy
Recruitment hospital [2] 0 0
ImClone Investigational Site - Frankston
Recruitment hospital [3] 0 0
ImClone Investigational Site - Bankstown
Recruitment hospital [4] 0 0
ImClone Investigational Site - Bedford Park
Recruitment hospital [5] 0 0
ImClone Investigational Site - Box Hill
Recruitment hospital [6] 0 0
ImClone Investigational Site - Darlinghurst
Recruitment hospital [7] 0 0
ImClone Investigational Site - East Bentleigh
Recruitment hospital [8] 0 0
ImClone Investigational Site - East Melbourne
Recruitment hospital [9] 0 0
ImClone Investigational Site - Herston
Recruitment hospital [10] 0 0
ImClone Investigational Site - Hobart
Recruitment hospital [11] 0 0
ImClone Investigational Site - Milton
Recruitment hospital [12] 0 0
ImClone Investigational Site - Nambour
Recruitment hospital [13] 0 0
ImClone Investigational Site - New Lambton Heights
Recruitment hospital [14] 0 0
ImClone Investigational Site - Perth
Recruitment hospital [15] 0 0
ImClone Investigational Site - Ringwood East
Recruitment hospital [16] 0 0
ImClone Investigational Site - Subiaco
Recruitment hospital [17] 0 0
ImClone Investigational Site - Sydney
Recruitment hospital [18] 0 0
ImClone Investigational Site - Tweed Heads
Recruitment hospital [19] 0 0
ImClone Investigational Site - Wendouree
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment postcode(s) [3] 0 0
NSW2200 - Bankstown
Recruitment postcode(s) [4] 0 0
SA 5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
V1C 3128 - Box Hill
Recruitment postcode(s) [6] 0 0
NSW 2010 - Darlinghurst
Recruitment postcode(s) [7] 0 0
VIC 3165 - East Bentleigh
Recruitment postcode(s) [8] 0 0
3002 - East Melbourne
Recruitment postcode(s) [9] 0 0
QLD 4029 - Herston
Recruitment postcode(s) [10] 0 0
7000 - Hobart
Recruitment postcode(s) [11] 0 0
QLD 4064 - Milton
Recruitment postcode(s) [12] 0 0
QLD 4560 - Nambour
Recruitment postcode(s) [13] 0 0
NSW 2305 - New Lambton Heights
Recruitment postcode(s) [14] 0 0
WA 6001 - Perth
Recruitment postcode(s) [15] 0 0
3135 - Ringwood East
Recruitment postcode(s) [16] 0 0
6008 - Subiaco
Recruitment postcode(s) [17] 0 0
NSW 2010 - Sydney
Recruitment postcode(s) [18] 0 0
NSW 2305 - Tweed Heads
Recruitment postcode(s) [19] 0 0
VIC 3355 - Wendouree
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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United States of America
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Colorado
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Florida
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Georgia
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Illinois
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Indiana
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Kentucky
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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Nevada
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New York
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North Carolina
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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Utah
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Belgium
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Brasschaat
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Belgium
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Charleroi
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Kortrijk
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Belgium
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Liege
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Namur
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Yvoir
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Ijui
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Motol
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Alexandria
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Cairo
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Chemnitz
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Kiel
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Lubeck
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Munchen
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Munich
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Oldenburg
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Germany
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Saarbrucken
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Germany
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Trier
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Germany
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Tubingen
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Ireland
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Cork
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Ireland
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Dublin
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Erlangen
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Limerick
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Beersheva
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Israel
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Jerusalem
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Israel
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Petach-Tikva
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Israel
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Rehovot
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Israel
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Tel Aviv
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Korea, Republic of
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Incheon
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Seoul
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Bsalim
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Saïda
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Zgharta
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Auckland
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Palmerston North
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Peru
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Arequipa
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Peru
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Lima
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Poland
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Bytom
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Russian Federation
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Engels
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Russian Federation
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Russian Federation
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Kursk
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Russian Federation
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Leningrad Region
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Russian Federation
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Lipetsk
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Russian Federation
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Magnitogorsk
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Russian Federation
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Moscow
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Russian Federation
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Orenburg
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Samara
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Tambov
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Russian Federation
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Ufa
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Serbia
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Kragujevac
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Serbia
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Nis
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Serbia
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Sremska Kamenica
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Bratislava
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Slovakia
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Trnava
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Zilina
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South Africa
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Johannesburg
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Amanzimtoti
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Bloemfontein
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Durban
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Lynnwood
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Port Elizabeth
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Pretoria
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Sandton
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Alicante
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Badalona
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Barbastro
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Barcelona
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Girona
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Jaen
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Spain
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La Coruna
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Spain
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La Laguna - Tenerife
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Spain
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Lleida
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Palma de Mallorca
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Spain
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Salamanca
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Spain
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San Sebastian
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Spain
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Santander
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Sevilla
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Spain
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Toledo
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Spain
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Valencia
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Spain
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Zaragoza
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Taiwan
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Changhua
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Taiwan
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Taipei
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Taiwan
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Taoyuan County
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United Kingdom
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Bournemouth
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United Kingdom
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Edinburgh
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United Kingdom
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Huddersfield
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United Kingdom
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Hull
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United Kingdom
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Manchester
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United Kingdom
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Nottingham

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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 9 AM - 5 PM 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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and european union (EU), whichever is later. Data will be indefinitely available for requesting.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT00703326