A Study of Ramucirumab (IMC-1121B) in Combination With Eribulin Versus Eribulin Alone in Participants With Breast Cancer
NCT ID: NCT01427933
Last Updated: 2017-02-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
141 participants
INTERVENTIONAL
2011-11-30
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ramucirumab and Eribulin
Ramucirumab 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle
Eribulin 1.4 milligrams/square meter (mg/m²) administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
Ramucirumab (IMC-1121B)
Administered intravenously
Eribulin
Administered intravenously
Eribulin Monotherapy
Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
Eribulin
Administered intravenously
Interventions
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Ramucirumab (IMC-1121B)
Administered intravenously
Eribulin
Administered intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have measurable and/or nonmeasurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
* Have received at least 2 but not more than 4 prior cytotoxic chemotherapy regimens in the locally recurrent or metastatic setting
* Have received prior treatment with both anthracyclines and taxanes, either in the metastatic, adjuvant or neoadjuvant setting
* Have received Human Epidermal Growth Factor Receptor 2 (HER-2) directed treatment; or are not a candidate for HER-2-directed treatment if the patient has HER-2 positive disease
* Have completed any prior radiotherapy and/or hormonal therapy at least 1 week prior to randomization and have recovered from all clinically significant treatment-related toxicities
* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Have left ventricular ejection fraction within normal limits
* Have discontinued all previous chemotherapy treatments for cancer at least 3 weeks prior to randomization and recovered from clinically significant toxic effects
* Have resolution to Grade less than or equal to 1 \[by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 4.0\] of all clinically significant toxicities of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy, which must have resolved to Grade less than or equal to 2
* Have adequate hematologic, hepatic, renal, and coagulation function
* Test negative for pregnancy
* Have a life expectancy of at least 3 months
Exclusion Criteria
* Are currently enrolled in, or recently discontinued from, a clinical trial involving an investigational product, or concurrently enrolled in any other type of medical research judged not to be medically compatible with the study
* Have received investigational therapy within 3 weeks prior to randomization
* Have received prior ramucirumab or eribulin
* Have a known sensitivity to agents of similar biologic composition as ramucirumab, halichondrin B and/or halichondrin B chemical derivative
* Have received bevacizumab within 6 weeks prior to randomization
* Have uncontrolled or poorly controlled hypertension
* Have congenital prolonged QTc syndrome (or have a family history) or prolongation of QTc at baseline
* Have a history of additional risk factors for torsades de pointes within the last year prior to randomization
* Have an implantable pacemaker or automatic implantable cardioverter defibrillator
* Have bradycardia
* Have an acute/subacute bowel obstruction or history of chronic diarrhea requiring ongoing medical intervention within 6 months prior to randomization
* Have a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
* Have experienced a Grade 3 or greater bleeding event within 3 months prior to randomization
* Have experienced any Grade 3 or greater arterial thromboembolic events within 6 months prior to randomization, or venous thromboembolic event within 3 months prior to randomization
* Have undergone major surgery within 4 weeks prior to randomization or subcutaneous venous access device placement within 7 days prior to randomization
* Have a planned major surgery to be performed during the course of the trial
* Have uncontrolled metabolic conditions
* Have an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy
* Have known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
* Have pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment including the use of oxygen
* Have received a prior allogeneic organ or tissue transplantation
* Have had a serious nonhealing wound, ulcer, or bone fracture within 4 weeks prior to randomization
* Have known leptomeningeal metastases
* Have cirrhosis (Child-Pugh Level B or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites
18 Years
FEMALE
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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ImClone Investigational Site
Birmingham, Alabama, United States
ImClone Investigational Site
Gilroy, California, United States
ImClone Investigational Site
Palm Springs, California, United States
ImClone Investigational Site
Denver, Colorado, United States
ImClone Investigational Site
Southington, Connecticut, United States
ImClone Investigational Site
Fort Myers, Florida, United States
ImClone Investigational Site
Jacksonville, Florida, United States
ImClone Investigational Site
Orlando, Florida, United States
ImClone Investigational Site
Plantation, Florida, United States
ImClone Investigational Site
Port Saint Lucie, Florida, United States
ImClone Investigational Site
St. Petersburg, Florida, United States
ImClone Investigational Site
Tampa, Florida, United States
ImClone Investigational Site
Albany, Georgia, United States
ImClone Investigational Site
Lawrenceville, Georgia, United States
ImClone Investigational Site
Park Ridge, Illinois, United States
ImClone Investigational Site
Columbia, Maryland, United States
ImClone Investigational Site
Rockville, Maryland, United States
ImClone Investigational Site
Dearborn, Michigan, United States
ImClone Investigational Site
Minneapolis, Minnesota, United States
ImClone Investigational Site
Saint Joseph, Missouri, United States
ImClone Investigational Site
St Louis, Missouri, United States
ImClone Investigational Site
Henderson, Nevada, United States
ImClone Investigational Site
Morristown, New Jersey, United States
ImClone Investigational Site
Johnson City, New York, United States
ImClone Investigational Site
Lake Success, New York, United States
ImClone Investigational Site
The Bronx, New York, United States
ImClone Investigational Site
Burlington, North Carolina, United States
ImClone Investigational Site
Chapel Hill, North Carolina, United States
ImClone Investigational Site
Dayton, Ohio, United States
ImClone Investigational Site
Middletown, Ohio, United States
ImClone Investigational Site
Toledo, Ohio, United States
ImClone Investigational Site
Portland, Oregon, United States
ImClone Investigational Site
Pittsburgh, Pennsylvania, United States
ImClone Investigational Site
Charleston, South Carolina, United States
ImClone Investigational Site
Greenville, South Carolina, United States
ImClone Investigational Site
Chattanooga, Tennessee, United States
ImClone Investigational Site
Nashville, Tennessee, United States
ImClone Investigational Site
Arlington, Texas, United States
ImClone Investigational Site
Bedford, Texas, United States
ImClone Investigational Site
Dallas, Texas, United States
ImClone Investigational Site
Fort Worth, Texas, United States
ImClone Investigational Site
Houston, Texas, United States
ImClone Investigational Site
Plano, Texas, United States
ImClone Investigational Site
San Antonio, Texas, United States
ImClone Investigational Site
The Woodlands, Texas, United States
ImClone Investigational Site
Tyler, Texas, United States
ImClone Investigational Site
Rutland, Vermont, United States
ImClone Investigational Site
Fairfax, Virginia, United States
ImClone Investigational Site
Norfolk, Virginia, United States
ImClone Investigational Site
Richmond, Virginia, United States
ImClone Investigational Site
Salem, Virginia, United States
ImClone Investigational Site
Vancouver, Washington, United States
Countries
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Other Identifiers
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I4T-IE-JVCD
Identifier Type: OTHER
Identifier Source: secondary_id
CP12-1134
Identifier Type: OTHER
Identifier Source: secondary_id
14392
Identifier Type: -
Identifier Source: org_study_id
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