Trial record 1 of 1 for:    NCT01427933
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A Study of Ramucirumab (IMC-1121B) in Combination With Eribulin Versus Eribulin Alone in Patients With Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01427933
First received: August 31, 2011
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Breast Cancer
Biological: Ramucirumab (IMC-1121B)
Drug: Eribulin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter, Randomized, Phase 2 Study Evaluating the Efficacy and Safety of Ramucirumab (IMC-1121B) Drug Product in Combination With Eribulin Versus Eribulin Monotherapy in Unresectable, Locally-Recurrent or Metastatic Breast Cancer Patients Previously Treated With Anthracycline and Taxane Therapy

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Progression‐free survival (PFS) [ Time Frame: Every 2 cycles (6 weeks) from start of treatment until documented disease progression or death from any cause. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival - baseline to date of death from any cause [ Time Frame: Approximately 2 years ] [ Designated as safety issue: Yes ]
  • Objective response rate - proportion of patients with measurable disease achieving a best overall response of Partial Response or Complete Response [ Time Frame: Every 2 cycles (6 weeks) from start of treatment until documented best response ] [ Designated as safety issue: No ]
  • Duration of Response - time of response to progressive disease [ Time Frame: Approximately 2 years ] [ Designated as safety issue: No ]
  • Change in tumor size [ Time Frame: Every 6 weeks from baseline until participant discontinues study treatment ] [ Designated as safety issue: No ]
  • Incidence of anti-Ramucirumab antibodies [ Time Frame: Day 1 of Cycle 1, Cycle 3, Cycle 5 and 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]

Enrollment: 141
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ramucirumab and Eribulin

Ramucirumab 10 mg/kg administered by IV infusion on Day 1 of each 3-week cycle

Eribulin 1.4 mg/m^2 administered by IV bolus on Day 1 and Day 8 of each 3-week cycle

Biological: Ramucirumab (IMC-1121B)
Administered intravenously
Other Name: LY3009806
Drug: Eribulin
Administered intravenously
Active Comparator: Eribulin Monotherapy
Eribulin 1.4 mg/m^2 administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
Drug: Eribulin
Administered intravenously

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 (RECIST 1.1)
  • 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 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:

  • 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 des 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427933

  Show 52 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01427933     History of Changes
Other Study ID Numbers: 14392, 14T-IE-JVCD, CP12-1134
Study First Received: August 31, 2011
Last Updated: September 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 15, 2014