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An Open-Label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Ramucirumab (IMC-1121B) Drug Product or IMC-18F1 in Combination With Capecitabine or Capecitabine Monotherapy, in Unresectable, Locally Advanced or Metastatic Breast Cancer Patients Previously Treated With Anthracycline and Taxane Therapy


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

Thank you

Trial Information

An Open-Label, Multicenter, Randomized Phase 2 Study Evaluating the Safety and Efficacy of Ramucirumab (IMC-1121B) Drug Product or IMC-18F1 in Combination With Capecitabine or Capecitabine Monotherapy, in Unresectable, Locally Advanced or Metastatic Breast Cancer Patients Previously Treated With Anthracycline and Taxane Therapy


Inclusion Criteria:



- The patient has histologically or cytologically confirmed breast cancer which at the
time of study entry is either Stage III disease not amenable to curative therapy or
Stage IV disease

- Has measurable or nonmeasurable disease

- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

- Has received prior anthracycline therapy

- Has received prior taxane therapy

- Patients with HER2-positive disease must have progressed on or following trastuzumab

- Patients with hormone receptor-positive disease must have progressed on or following
hormone therapy

- Has received ≤ 3 prior chemotherapy regimens in any setting (a regimen is defined as
any agent[s] that has been administered for more than 1 cycle; sequential
neoadjuvant/adjuvant treatment is considered 1 regimen)

- Has completed any prior radiotherapy ≥ 4 weeks prior to randomization

- Has completed any prior hormonal therapy ≥ 2 weeks prior to randomization

- Has AEs that have resolved to Grade ≤ 1 by the National Cancer Institute Common
Terminology Criteria for Adverse Events, Version 4.0 (NCI-CTCAE v 4.0) from all
clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy,or
hormonal therapy

- Has adequate hematologic, coagulation, hepatic and renal function

- Does not have:

- cirrhosis at a level of Child-Pugh B (or worse) or

- cirrhosis (any degree) and a history of hepatic encephalopathy or ascites
resulting from cirrhosis and requiring ongoing treatment with diuretics and/or
paracentesis

- Has urinary protein is ≤ 1+ on dipstick or routine urinalysis; if urine protein ≥ 2+,
a 24-hour urine collection must demonstrate < 1000 mg of protein in 24 hours to allow
participation in the study

- Agrees to use adequate contraception during the study period and for 12 weeks after
the last dose of study medication

Exclusion Criteria:

- Has a concurrent active malignancy other than adequately treated nonmelanomatous skin
cancer, curatively treated cervical carcinoma in situ, or other noninvasive carcinoma
or in situ neoplasm. A patient with previous history of malignancy is eligible,
provided that there has been a disease-free interval for > 3 years

- Has a known sensitivity to capecitabine, any of its components, or other drugs
formulated with polysorbate 80

- Has a known sensitivity to 5-FU

- Has a known dihydropyrimidine dehydrogenase deficiency

- Has received prior capecitabine treatment for advanced breast cancer

- Has received investigational therapy within 2 weeks prior to randomization

- Has received bevacizumab within 4 weeks prior to randomization

- Has received more than 1 prior antiangiogenic agent for breast cancer

- Has a known sensitivity to agents of similar biologic composition as ramucirumab DP
or IMC-18F1, or other agents that specifically target VEGF

- Has an acute/subacute bowel obstruction or history of chronic diarrhea requiring
ongoing medical intervention

- Has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders

- Has experienced a Grade ≥ 3 bleeding event within 3 months prior to randomization

- Is receiving prophylactic or therapeutic anticoagulation with warfarin or any other
oral anticoagulant

- Has an uncontrolled intercurrent illness, including, but not limited to uncontrolled
hypertension, symptomatic anemia, symptomatic congestive heart failure, unstable
angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric
illness/social situations, or any other serious uncontrolled medical disorder in the
opinion of the investigator

- Has experienced any arterial thrombotic or thromboembolic events, including, but not
limited to myocardial infarction, transient ischemic attack, or cerebrovascular
accident within 6 months prior to randomization

- Has brain metastases, uncontrolled spinal cord compression, or leptomeningeal disease

- Has an ongoing or active infection requiring parenteral antibiotic, antifungal, or
antiviral therapy

- Has received a prior allogeneic organ or tissue transplantation

- Has undergone major surgery within 4 weeks prior to randomization, or subcutaneous
venous access device placement within 7 days prior to randomization

- Has had a serious nonhealing wound, ulcer, or bone fracture within 4 weeks prior to
randomization

- Has known HIV or AIDS infection

- Has an elective or planned major surgery to be performed during the course of the
trial

- Patient is pregnant or lactating

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:

Progression-Free Survival (PFS)

Outcome Time Frame:

Approximately 31 Months

Safety Issue:

No

Principal Investigator

E-mail: ClinicalTrials@ ImClone.com

Investigator Role:

Study Director

Investigator Affiliation:

ImClone LLC

Authority:

United States: Food and Drug Administration

Study ID:

13944

NCT ID:

NCT01234402

Start Date:

March 2011

Completion Date:

September 2014

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast Neoplasms

Name

Location

ImClone Investigational Site Indianapolis, Indiana  46202
ImClone Investigational Site New York, New York  10021
ImClone Investigational Site Bakersfield, California  93309
ImClone Investigational Site Jacksonville, Florida  32207
ImClone Investigational Site Atlanta, Georgia  30318
ImClone Investigational Site Decatur, Illinois  62526
ImClone Investigational Site New Orleans, Louisiana  70121
ImClone Investigational Site Cleveland, Ohio  44134
ImClone Investigational Site Dallas, Texas  75230
ImClone Investigational Site Norfolk, Virginia  23502
ImClone Investigational Site Winston-Salem, North Carolina  27103
ImClone Investigational Site Ogden, Utah  84403
ImClone Investigational Site Tucson, Arizona  85712
ImClone Investigational Site Seattle, Washington  98104
ImClone Investigational Site Morgantown, West Virginia  26506