A Study of Ramucirumab (IMC-1121B) in Combination With Eribulin Versus Eribulin Alone in Participants With Breast Cancer

NCT01427933 | Completed Phase 2 Results DMC

• 3 other identifiers: 14392I4T-IE-JVCDCP12-1134
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 52

Brief Summary

This is a study to compare the antitumor activity of ramucirumab (IMC-1121B) and eribulin together versus eribulin alone, in participants with locally recurrent or metastatic breast cancer.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS was defined as time from date of randomization until the date of objectively determined progression defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria or death from any cause, whichever is first. Progressive disease (PD) defined as ≥20% increase in sum of diameter (SOD) of target lesion with the sum demonstrating an increase of ≥5 mm; appearance of ≥1 new lesions or unequivocal progression of non-target lesions. Participants with no baseline disease assessment were censored at randomization date, regardless of whether or not objectively determined PD or death was observed; participants not known to have died or to have objective progression as of data inclusion cutoff date were censored at last post baseline radiological assessment date or randomization date, if there was no post baseline radiological assessment.

  Start of treatment until documented disease progression or death from any cause up to 16.5 months

Secondary Outcomes (5)

• Overall Survival (OS) Randomization to Date of Death From Any Cause

  Randomization to date of death from any cause up to 28.6 months

• Objective Response Rate (ORR) Percentage of Participants With Measurable Disease Achieving a Best Overall Response of Partial Response (PR) or Complete Response (CR)

  Start of treatment until documented CR or PR up to 16.5 months

• Duration of Response (DOR) Time of Response to Progressive Disease

  Time from Observed CR or PR to PD up to 12.1 months

• Change in Tumor Size (CTS)

  Baseline, 6 weeks

• Number of Participants With Anti-Ramucirumab Antibodies

  Day 1 of Cycle 1, Cycle 3, Cycle 5 and 30 days after last dose of study drug up to 17.7 months

Other Outcomes (1)

• Number of Participants With Adverse Events (AE) and Participants Who Died

  Baseline up to end of treatment and within 30 days of last dose of study drug (22.6 months)

Study Arms (2)

Ramucirumab and Eribulin

EXPERIMENTAL

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

Biological: Ramucirumab (IMC-1121B); Drug: Eribulin

Eribulin Monotherapy

ACTIVE COMPARATOR

Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle

Drug: Eribulin

Interventions

Ramucirumab (IMC-1121B) BIOLOGICAL

Administered intravenously

Also known as: LY3009806

Ramucirumab and Eribulin

Eribulin DRUG

Administered intravenously

Eribulin Monotherapy; Ramucirumab and Eribulin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have histologically or cytologically confirmed invasive breast cancer which at the time of study entry is either locally recurrent disease not amenable to curative therapy or Stage IV disease (American Joint Committee on Cancer Staging Criteria for breast cancer)
• 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

You may not qualify if:

• Have a concurrent active other malignancy other than adequately treated non-melanomatous skin cancer or other noninvasive or in situ neoplasms
• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (52)

ImClone Investigational Site

Birmingham, Alabama, 35211, United States

Location

ImClone Investigational Site

Gilroy, California, 95020, United States

Location

ImClone Investigational Site

Palm Springs, California, 92262, United States

Location

ImClone Investigational Site

Denver, Colorado, 80220, United States

Location

ImClone Investigational Site

Southington, Connecticut, 06489, United States

Location

ImClone Investigational Site

Fort Myers, Florida, 33916, United States

Location

ImClone Investigational Site

Jacksonville, Florida, 32207, United States

Location

ImClone Investigational Site

Orlando, Florida, 32806, United States

Location

ImClone Investigational Site

Plantation, Florida, 33324, United States

Location

ImClone Investigational Site

Port Saint Lucie, Florida, 34952, United States

Location

ImClone Investigational Site

St. Petersburg, Florida, 33705, United States

Location

ImClone Investigational Site

Tampa, Florida, 33612, United States

Location

ImClone Investigational Site

Albany, Georgia, 31701, United States

Location

ImClone Investigational Site

Lawrenceville, Georgia, 30046, United States

Location

ImClone Investigational Site

Park Ridge, Illinois, 60068, United States

Location

ImClone Investigational Site

Columbia, Maryland, 21044, United States

Location

ImClone Investigational Site

Rockville, Maryland, 20850, United States

Location

ImClone Investigational Site

Dearborn, Michigan, 48126, United States

Location

ImClone Investigational Site

Minneapolis, Minnesota, 55404, United States

Location

ImClone Investigational Site

Saint Joseph, Missouri, 64507, United States

Location

ImClone Investigational Site

St Louis, Missouri, 63110, United States

Location

ImClone Investigational Site

Henderson, Nevada, 89074, United States

Location

ImClone Investigational Site

Morristown, New Jersey, 07960, United States

Location

ImClone Investigational Site

Johnson City, New York, 13790, United States

Location

ImClone Investigational Site

Lake Success, New York, 11042, United States

Location

ImClone Investigational Site

The Bronx, New York, 10469, United States

Location

ImClone Investigational Site

Burlington, North Carolina, 27215, United States

Location

ImClone Investigational Site

Chapel Hill, North Carolina, 27599, United States

Location

ImClone Investigational Site

Dayton, Ohio, 45429, United States

Location

ImClone Investigational Site

Middletown, Ohio, 45042, United States

Location

ImClone Investigational Site

Toledo, Ohio, 43623, United States

Location

ImClone Investigational Site

Portland, Oregon, 97213, United States

Location

ImClone Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

ImClone Investigational Site

Charleston, South Carolina, 29414, United States

Location

ImClone Investigational Site

Greenville, South Carolina, 29605, United States

Location

ImClone Investigational Site

Chattanooga, Tennessee, 37404, United States

Location

ImClone Investigational Site

Nashville, Tennessee, 37203, United States

Location

ImClone Investigational Site

Arlington, Texas, 76014, United States

Location

ImClone Investigational Site

Bedford, Texas, 76022, United States

Location

ImClone Investigational Site

Dallas, Texas, 75246, United States

Location

ImClone Investigational Site

Fort Worth, Texas, 76104, United States

Location

ImClone Investigational Site

Houston, Texas, 77024, United States

Location

ImClone Investigational Site

Plano, Texas, 75075, United States

Location

ImClone Investigational Site

San Antonio, Texas, 78217, United States

Location

ImClone Investigational Site

The Woodlands, Texas, 77380, United States

Location

ImClone Investigational Site

Tyler, Texas, 75702, United States

Location

ImClone Investigational Site

Rutland, Vermont, 05701, United States

Location

ImClone Investigational Site

Fairfax, Virginia, 22031, United States

Location

ImClone Investigational Site

Norfolk, Virginia, 23502, United States

Location

ImClone Investigational Site

Richmond, Virginia, 23230, United States

Location

ImClone Investigational Site

Salem, Virginia, 24153, United States

Location

ImClone Investigational Site

Vancouver, Washington, 98684, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ramucirumab; eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

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 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 2, 2011
• Study Start: November 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: June 1, 2014
• Last Updated: February 6, 2017
• Results First Posted: August 19, 2014

Record last verified: 2016-12

Locations

US (52)