NCT01183780

Brief Summary

The purpose of this study is to compare overall survival in participants with metastatic colorectal cancer treated with either ramucirumab and FOLFIRI or placebo and FOLFIRI.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,072

participants targeted

Target at P75+ for phase_3 colorectal-cancer

Timeline
Completed

Started Dec 2010

Typical duration for phase_3 colorectal-cancer

Geographic Reach
25 countries

210 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 18, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

December 2, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2014

Completed
12 months until next milestone

Results Posted

Study results publicly available

July 15, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2016

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

3.6 years

First QC Date

August 4, 2010

Results QC Date

June 19, 2015

Last Update Submit

September 10, 2019

Conditions

Colorectal Cancer

Keywords

second linemetastatic colorectal cancerFOLFIRIramucirumabCRCmCRC

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    OS was defined as the time in months from the date of randomization to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last known date alive.

    Randomization to Date of Death from Any Cause Up to 39.36 Months

Secondary Outcomes (6)

  • Progression-free Survival (PFS) Time

    Randomization to Measured PD or Date of Death from Any Cause Up to 38.01 Months

  • Percentage of Participants Achieving an Objective Response (Objective Response Rate)

    Randomization until Disease Progression Up to 38.01 Months

  • Change From Baseline in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30 Global Health Status

    Baseline Up to 171 Weeks

  • Change From Baseline in EuroQol- 5D (EQ-5D)

    Baseline and 30-Day Follow-Up (FU) up to 171 Weeks

  • Percentage of Participants With Treatment-Emergent Anti-Ramucirumab Antibodies

    Cycles 1, 3, 5, and 30-Day FU

  • +1 more secondary outcomes

Study Arms (2)

FOLFIRI + Ramucirumab

EXPERIMENTAL
Biological: RamucirumabDrug: IrinotecanDrug: Folinic AcidDrug: 5-Fluorouracil

FOLFIRI + Placebo

PLACEBO COMPARATOR
Biological: PlaceboDrug: IrinotecanDrug: Folinic AcidDrug: 5-Fluorouracil

Interventions

RamucirumabBIOLOGICAL

8 milligrams / kilogram (mg/kg) administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision

Also known as: LY3009806, IMC-1121B
FOLFIRI + Ramucirumab
PlaceboBIOLOGICAL

Administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision

FOLFIRI + Placebo
IrinotecanDRUG

180 milligrams/square meter (mg/m\^2) administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision

FOLFIRI + PlaceboFOLFIRI + Ramucirumab
Folinic AcidDRUG

400 mg/m\^2 administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision

Also known as: leucovorin
FOLFIRI + PlaceboFOLFIRI + Ramucirumab
5-FluorouracilDRUG

400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision

FOLFIRI + PlaceboFOLFIRI + Ramucirumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed colorectal cancer, excluding primary tumors of appendiceal origin (participants are eligible to enroll irrespective of KRAS mutation status)
  • Confirmed metastatic colorectal cancer (Stage IV)
  • The participant has received first-line combination therapy of bevacizumab, oxaliplatin, and a fluoropyrimidine for metastatic disease and, a) Experienced radiographic disease progression during first-line therapy, or b) Experienced radiographic disease progression ≤6 months after the last dose of first-line therapy, or c) Discontinued part or all of first-line therapy due to toxicity and experienced radiographic disease progression ≤6 months after the last dose of first-line therapy. Note that a participant must have received a minimum of 2 doses of bevacizumab as part of a first-line regimen containing chemotherapy; in addition, a participant must have received at least 1 cycle of first-line therapy that included bevacizumab, oxaliplatin and a fluoropyrimidine in the same cycle. Note that a participant must not have received more than 2 different fluoropyrimidines as part of a first-line regimen; disease progression is not an acceptable reason for discontinuing 1 fluoropyrimidine and starting a second fluoropyrimidine
  • Receipt of no more than 2 prior systemic chemotherapy regimens in any setting (only 1 prior regimen for metastatic disease is permitted). For participants with rectal cancer, sequential neoadjuvant and adjuvant therapy will count as a single systemic regimen. Note that rechallenge with oxaliplatin is permitted and will be considered part of the first-line regimen for metastatic disease, both initial oxaliplatin treatment and subsequent rechallenge are considered as 1 regimen
  • Measurable or nonmeasurable disease based on the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  • Adequate hematologic, renal and hepatic function
  • Adequate coagulation function \[International Normalized Ratio (INR) ≤1.5 and Partial Thromboplastin Time (PTT) or activated PTT (aPTT) ≤1.5 x upper limit of normal (ULN)). Participants on full-dose anticoagulation must be on a stable dose of anticoagulant therapy and if on oral anticoagulation, must have an INR ≤3 and have no clinically significant active bleeding or pathological condition that carries a high risk of bleeding
  • Consent to provide a historical colorectal cancer tissue sample for assessment of biomarkers and the tumor tissue sample is available
  • Ability to provide signed informed consent

You may not qualify if:

  • Receipt of bevacizumab ≤28 days prior to randomization
  • Receipt of any investigational therapy for non-oncology clinical indication ≤28 days prior to randomization
  • Receipt of any previous systemic therapy, other than a combination of bevacizumab, oxaliplatin, and a fluoropyrimidine, for first-line treatment of metastatic colorectal cancer
  • Known leptomeningeal disease or brain metastases or uncontrolled spinal cord compression (currently or in the past)
  • Experience of any arterial thrombotic or arterial thromboembolic events, including, but not limited to, myocardial infarction, transient ischemic attack, or cerebrovascular accident, ≤12 months prior to randomization
  • Pregnant (confirmed by serum beta human chorionic gonadotropin (ß HCG) test ≤7 days prior to randomization) or lactating
  • History of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization
  • Acute or subacute bowel obstruction or history of chronic diarrhea which is considered clinically significant in the opinion of the investigator
  • Grade 3 or higher bleeding event ≤3 months prior to randomization
  • Experience of any of the following during first-line therapy with a bevacizumab-containing regimen: an arterial thrombotic/thromboembolic event, Grade 4 hypertension, Grade 3 proteinuria, a Grade 3-4 bleeding event, or bowel perforation
  • Known history or clinical evidence of Gilbert's Syndrome, or is known to have any of the following genotypes: UGT1A1\*6/\*6, UGT1A1\*28/\*28, or UGT1A1\*6/\*28
  • Known allergy to any of the study treatment components, including any components used in the preparation of ramucirumab, or other contraindication to receive the study treatments
  • Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinical meaningful ascites resulting from cirrhosis; Clinically meaningful ascites is defined as ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (213)

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Sedona, Arizona, 86336, United States

Location

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Tucson, Arizona, 85715, United States

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Fayetteville, Arkansas, 72703, United States

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Little Rock, Arkansas, 72205, United States

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Duarte, California, 91010, United States

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Escondido, California, 92025, United States

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Fresno, California, 93720, United States

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Greenbrae, California, 94904, United States

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La Jolla, California, 92093, United States

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Rancho Cucamonga, California, 91730, United States

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San Diego, California, 92108, United States

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Denver, Colorado, 80218, United States

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Waterbury, Connecticut, 06708, United States

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Boynton Beach, Florida, 33426, United States

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Fort Lauderdale, Florida, 33308, United States

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Fort Myers, Florida, 33916, United States

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Miami, Florida, 33176, United States

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Ocala, Florida, 34471, United States

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Port Saint Lucie, Florida, 34952, United States

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St. Petersburg, Florida, 33705, United States

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Titusville, Florida, 32796, United States

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Athens, Georgia, 30607, United States

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Augusta, Georgia, 30901, United States

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Macon, Georgia, 31201, United States

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Marietta, Georgia, 30060, United States

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Rome, Georgia, 30165, United States

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Thomasville, Georgia, 31792, United States

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Honolulu, Hawaii, 96819, United States

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Harvey, Illinois, 60426, United States

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Peoria, Illinois, 61615, United States

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Warrenville, Illinois, 60555, United States

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Goshen, Indiana, 46526, United States

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Indianapolis, Indiana, 46237, United States

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Muncie, Indiana, 47303, United States

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Bethesda, Maryland, 20817, United States

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Minneapolis, Minnesota, 55404, United States

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Columbia, Missouri, 65201, United States

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St Louis, Missouri, 63110, United States

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Billings, Montana, 59101, United States

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Las Vegas, Nevada, 89169, United States

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Cherry Hill, New Jersey, 08003, United States

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Hackensack, New Jersey, 07601, United States

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Morristown, New Jersey, 07962, United States

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Albuquerque, New Mexico, 87109, United States

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Hudson, New York, 12534, United States

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Jamaica, New York, 11432, United States

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New York, New York, 10029, United States

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The Bronx, New York, 10467, United States

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Raleigh, North Carolina, 27607, United States

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Cincinnati, Ohio, 45242, United States

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Columbus, Ohio, 43219, United States

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Tulsa, Oklahoma, 74136, United States

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Bend, Oregon, 97701, United States

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Portland, Oregon, 97227, United States

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Kingston, Pennsylvania, 18704, United States

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Philadelphia, Pennsylvania, 19106, United States

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Willow Grove, Pennsylvania, 19090, United States

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Columbia, South Carolina, 29210, United States

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Memphis, Tennessee, 38138, United States

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Nashville, Tennessee, 37203, United States

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Abilene, Texas, 79606, United States

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Arlington, Texas, 76014, United States

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Beaumont, Texas, 77702, United States

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Bedford, Texas, 76022, United States

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Dallas, Texas, 75246, United States

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Denton, Texas, 76210, United States

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Flower Mound, Texas, 75028, United States

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Fort Worth, Texas, 76104, United States

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Garland, Texas, 75042, United States

Location

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McAllen, Texas, 78503, United States

Location

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Odessa, Texas, 79761, United States

Location

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Paris, Texas, 75460, United States

Location

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Round Rock, Texas, 78665, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Sherman, Texas, 75090, United States

Location

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Sugar Land, Texas, 77479, United States

Location

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Temple, Texas, 76508, United States

Location

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The Woodlands, Texas, 77380, United States

Location

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Tyler, Texas, 75702, United States

Location

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Waco, Texas, 76712, United States

Location

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Webster, Texas, 77598, United States

Location

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Wichita Falls, Texas, 76310, United States

Location

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Ogden, Utah, 84403, United States

Location

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Salt Lake City, Utah, 84106, United States

Location

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Fairfax, Virginia, 22031, United States

Location

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Newport News, Virginia, 23606, United States

Location

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Richmond, Virginia, 23230, United States

Location

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Winchester, Virginia, 22601, United States

Location

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Kennewick, Washington, 99336, United States

Location

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Seattle, Washington, 98109, United States

Location

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Spokane Valley, Washington, 99216, United States

Location

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Milwaukee, Wisconsin, 53226, United States

Location

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Buenos Aires, B8000FJI, Argentina

Location

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Caba, C1180AAX, Argentina

Location

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Rosario, 2000, Argentina

Location

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Santa Fe, 3000, Argentina

Location

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Tucumain, 4000, Argentina

Location

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Viedma, 8500, Argentina

Location

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Liverpool, New South Wales, 2170, Australia

Location

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Randwick, New South Wales, 2031, Australia

Location

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St Leonards, New South Wales, 2065, Australia

Location

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Wodonga, New South Wales, 3690, Australia

Location

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Wollongong, New South Wales, 2500, Australia

Location

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Woolloongabba, Queensland, 4102, Australia

Location

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Bedford Park, South Australia, 5042, Australia

Location

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Elizabeth Vale, South Australia, 5112, Australia

Location

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Innsbruck, 6020, Austria

Location

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Krems, 3500, Austria

Location

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Vienna, A1090, Austria

Location

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Bonheiden, 2820, Belgium

Location

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Brussels, 1070, Belgium

Location

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Charleroi, 6000, Belgium

Location

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Edegem, 2650, Belgium

Location

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Haine-St.- Paul, 7100, Belgium

Location

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Leuven, 3000, Belgium

Location

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Liège, 4000, Belgium

Location

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Ijuí, 98700 000, Brazil

Location

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Itajaí, 88301-220, Brazil

Location

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Rio de Janeiro, 20231-050, Brazil

Location

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Salvador, 41823-010, Brazil

Location

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São José do Rio Preto, 15025-100, Brazil

Location

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São Paulo, 01308-050, Brazil

Location

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Brno, 656 53, Czechia

Location

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Pardubice, 532 03, Czechia

Location

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Prague, 150 06, Czechia

Location

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Copenhagen, 2100, Denmark

Location

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Odense, 5000, Denmark

Location

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Helsinki, 00029 HUS, Finland

Location

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Tampere, 33521, Finland

Location

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Bordeaux, 33076, France

Location

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La Chaussée-Saint-Victor, 41260, France

Location

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Le Mans, 72000, France

Location

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Nantes, 44202, France

Location

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Paris, 75015, France

Location

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Poitiers, 86021, France

Location

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Strasbourg, 67000, France

Location

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Augsburg, 86150, Germany

Location

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Balingen, 72336, Germany

Location

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Bamberg, 96049, Germany

Location

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Dresden, 01307, Germany

Location

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Frankfurt, 60488, Germany

Location

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Halle, 06120, Germany

Location

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Hamburg, 20249, Germany

Location

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Lübeck, 23562, Germany

Location

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Mönchengladbach, 41063, Germany

Location

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Munich, 81925, Germany

Location

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Weiden, 92637, Germany

Location

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Athens, 10676, Greece

Location

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Chania, 73300, Greece

Location

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Ioannina, 45500, Greece

Location

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Budapest, 1115, Hungary

Location

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Kecskemét, 6000, Hungary

Location

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Bangalore, 560027, India

Location

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Kochi, 628040, India

Location

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Kolkata, 700053, India

Location

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New Delhi, 110 060, India

Location

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Trivandrum, 695 011, India

Location

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Beersheba, 84101, Israel

Location

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Haifa, 31096, Israel

Location

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Tel Aviv, 64239, Israel

Location

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Tel Litwinsky, 52621, Israel

Location

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Genova, 16132, Italy

Location

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Livorno, 57124, Italy

Location

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Macerata, 62100, Italy

Location

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Padua, 35128, Italy

Location

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Reggio Emilia, 42100, Italy

Location

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Rome, 00168, Italy

Location

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Aichi, 464, Japan

Location

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Chiba, 277 8577, Japan

Location

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Ehime, 790-0007, Japan

Location

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Fukuoka, 811-1395, Japan

Location

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Gifu, 501-1194, Japan

Location

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Hokkaido, 060-8638, Japan

Location

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Hyōgo, 650-0046, Japan

Location

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Kanagawa, 216-8511, Japan

Location

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Kochi, 781-8555, Japan

Location

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Osaka, 569-8686, Japan

Location

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Saitama, 362-0806, Japan

Location

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Shizuoka, 411-8777, Japan

Location

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Tochigi, 329-0498, Japan

Location

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Tokyo, 104-0045, Japan

Location

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Breda, 4819 EV, Netherlands

Location

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Deventer, 7416 SE, Netherlands

Location

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Eindhoven, 5623 EJ, Netherlands

Location

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Groningen, 9728 NT, Netherlands

Location

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Sittard - Geleen, 6162 BG, Netherlands

Location

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Coimbra, 3000-075, Portugal

Location

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Porto, 4200-072, Portugal

Location

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Bayamón, 00959, Puerto Rico

Location

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Bucharest, 022328, Romania

Location

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Cluj-Napoca, 400015, Romania

Location

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Iași, 700106, Romania

Location

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Oradea, 410469, Romania

Location

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Ljubljana, 1001, Slovenia

Location

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Anyang, 431-070, South Korea

Location

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Goyang-si, 411-764, South Korea

Location

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Incheon, 405-760, South Korea

Location

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Seoul, 134-791, South Korea

Location

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Suwon, 442-721, South Korea

Location

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Barcelona, 08035, Spain

Location

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Madrid, 28097, Spain

Location

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Oviedo, 33006, Spain

Location

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Pamplona, 31008, Spain

Location

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Sabadell, 08208, Spain

Location

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Seville, 41013, Spain

Location

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Valencia, 46014, Spain

Location

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Stockholm, 17176, Sweden

Location

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Uppsala, 75185, Sweden

Location

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Kaohsiung City, 807, Taiwan

Location

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Kuei Shan Hsiang, 33305, Taiwan

Location

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Taichung, 40705, Taiwan

Location

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Tainan, 70403, Taiwan

Location

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Taipei, 100, Taiwan

Location

Related Publications (8)

  • Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.

    PMID: 34795131DERIVED

  • Taniguchi H, Yoshino T, Yamaguchi K, Yamazaki K, Nixon AB, Tabernero J, Van Cutsem E, Robling KR, Abada PB, Hozak RR, Siegel R, Fill JA, Wijayawardana S, Walgren RA, Giles B, Jones A, Pitts KR, Drove N, Muro K. Clinical development and evaluation of a VEGF-D assay in plasma from patients with metastatic colorectal cancer in the RAISE study. Curr Med Res Opin. 2021 Oct;37(10):1769-1778. doi: 10.1080/03007995.2021.1940908. Epub 2021 Jul 28.

    PMID: 34229554DERIVED

  • Lim HH, Hopkins AM, Rowland A, Yuen HY, Karapetis CS, Sorich MJ. Effect of Early Adverse Events on Survival Outcomes of Patients with Metastatic Colorectal Cancer Treated with Ramucirumab. Target Oncol. 2019 Dec;14(6):743-748. doi: 10.1007/s11523-019-00683-z.

    PMID: 31676953DERIVED

  • Yoshino T, Portnoy DC, Obermannova R, Bodoky G, Prausova J, Garcia-Carbonero R, Ciuleanu T, Garcia-Alfonso P, Cohn AL, Van Cutsem E, Yamazaki K, Lonardi S, Muro K, Kim TW, Yamaguchi K, Grothey A, O'Connor J, Taieb J, Wijayawardana SR, Hozak RR, Nasroulah F, Tabernero J. Biomarker analysis beyond angiogenesis: RAS/RAF mutation status, tumour sidedness, and second-line ramucirumab efficacy in patients with metastatic colorectal carcinoma from RAISE-a global phase III study. Ann Oncol. 2019 Jan 1;30(1):124-131. doi: 10.1093/annonc/mdy461.

    PMID: 30339194DERIVED

  • Grothey A, Yoshino T, Bodoky G, Ciuleanu T, Garcia-Carbonero R, Garcia-Alfonso P, Van Cutsem E, Muro K, Mytelka DS, Li L, Lipkovich O, Hsu Y, Sashegyi A, Ferry D, Nasroulah F, Tabernero J. Association of baseline absolute neutrophil counts and survival in patients with metastatic colorectal cancer treated with second-line antiangiogenic therapies: exploratory analyses of the RAISE trial and validation in an electronic medical record data set. ESMO Open. 2018 Apr 24;3(3):e000347. doi: 10.1136/esmoopen-2018-000347. eCollection 2018.

    PMID: 29713498DERIVED

  • Tabernero J, Hozak RR, Yoshino T, Cohn AL, Obermannova R, Bodoky G, Garcia-Carbonero R, Ciuleanu TE, Portnoy DC, Prausova J, Muro K, Siegel RW, Konrad RJ, Ouyang H, Melemed SA, Ferry D, Nasroulah F, Van Cutsem E. Analysis of angiogenesis biomarkers for ramucirumab efficacy in patients with metastatic colorectal cancer from RAISE, a global, randomized, double-blind, phase III study. Ann Oncol. 2018 Mar 1;29(3):602-609. doi: 10.1093/annonc/mdx767.

    PMID: 29228087DERIVED

  • Obermannova R, Van Cutsem E, Yoshino T, Bodoky G, Prausova J, Garcia-Carbonero R, Ciuleanu T, Garcia Alfonso P, Portnoy D, Cohn A, Yamazaki K, Clingan P, Lonardi S, Kim TW, Yang L, Nasroulah F, Tabernero J. Subgroup analysis in RAISE: a randomized, double-blind phase III study of irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI) plus ramucirumab or placebo in patients with metastatic colorectal carcinoma progression. Ann Oncol. 2016 Nov;27(11):2082-2090. doi: 10.1093/annonc/mdw402. Epub 2016 Aug 29.

    PMID: 27573561DERIVED

  • Tabernero J, Yoshino T, Cohn AL, Obermannova R, Bodoky G, Garcia-Carbonero R, Ciuleanu TE, Portnoy DC, Van Cutsem E, Grothey A, Prausova J, Garcia-Alfonso P, Yamazaki K, Clingan PR, Lonardi S, Kim TW, Simms L, Chang SC, Nasroulah F; RAISE Study Investigators. Ramucirumab versus placebo in combination with second-line FOLFIRI in patients with metastatic colorectal carcinoma that progressed during or after first-line therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine (RAISE): a randomised, double-blind, multicentre, phase 3 study. Lancet Oncol. 2015 May;16(5):499-508. doi: 10.1016/S1470-2045(15)70127-0. Epub 2015 Apr 12.

    PMID: 25877855DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

RamucirumabIrinotecanLeucovorinFluorouracil

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCamptothecinAlkaloidsHeterocyclic CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2010

First Posted

August 18, 2010

Study Start

December 2, 2010

Primary Completion

July 17, 2014

Study Completion

June 20, 2016

Last Updated

September 25, 2019

Results First Posted

July 15, 2015

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
More information

Locations

PT(2)AU(8)IN(5)TW(5)SE(2)JP(14)FR(7)AR(6)DE(11)HU(2)US(92)BE(7)IT(6)NL(5)RO(4)IL(4)CZ(3)FI(2)SL(1)KR(5)ES(7)PR(1)BR(6)DK(2)GR(3)