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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progressionā€free survival (PFS)

Outcome Time Frame:

Every 2 cycles (6 weeks) from start of treatment until documented disease progression or death from any cause.

Safety Issue:

No

Principal Investigator

Email: ClinicalTrials@ImClone.com

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

14392

NCT ID:

NCT01427933

Start Date:

November 2011

Completion Date:

January 2015

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast Neoplasms

Name

Location

ImClone Investigational SiteDenver, Colorado  80262
ImClone Investigational SiteGreenwich, Connecticut  06830
ImClone Investigational SiteNew York, New York  10021
ImClone Investigational SiteSt. Charles, Missouri  63301
ImClone Investigational SiteBakersfield, California  93309
ImClone Investigational SiteJacksonville, Florida  32207
ImClone Investigational SiteAtlanta, Georgia  30318
ImClone Investigational SiteDecatur, Illinois  62526
ImClone Investigational SiteBaltimore, Maryland  21204
ImClone Investigational SiteYpsilanti, Michigan  48198
ImClone Investigational SiteMinneapolis, Minnesota  55416
ImClone Investigational SiteLas Vegas, Nevada  89109
ImClone Investigational SiteVoorhees, New Jersey  08043
ImClone Investigational SiteCleveland, Ohio  44134
ImClone Investigational SitePortland, Oregon  97239
ImClone Investigational SiteGreenville, South Carolina  29605
ImClone Investigational SiteMemphis, Tennessee  38104
ImClone Investigational SiteDallas, Texas  75230
ImClone Investigational SiteNorfolk, Virginia  23502
ImClone Investigational SiteWinston-Salem, North Carolina  27103
ImClone Investigational SitePhiladelphia, Pennsylvania  19107
ImClone Investigational SiteSeattle, Washington  98104
ImClone Investigational SiteBirmingham, Alabama  35233
ImClone Investigational SiteRutland, Vermont  05701