Status:
COMPLETED
Study of Icrucumab (IMC-18F1) or Ramucirumab Drug Product (DP) in Combination With Capecitabine or Capecitabine on Previously Treated Breast Cancer Patients
Lead Sponsor:
Eli Lilly and Company
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
An open-label, multicenter, randomized, Phase 2 trial in which participant with unresectable, locally advanced or metastatic breast cancer who have been previously treated with anthracycline and taxan...
Eligibility Criteria
Inclusion
- The participant 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
- Participants with human epidermal growth factor receptor-2 (HER2) positive disease must have progressed on or following trastuzumab
- Participants 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 adverse events (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
- 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 participant 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-fluorouracil (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 Icrucumab (IMC-18F1), or other agents that specifically target vascular endothelial growth factor (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
- Participant is pregnant or lactating
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2017
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT01234402
Start Date
March 1 2011
End Date
July 1 2017
Last Update
August 14 2019
Active Locations (23)
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1
ImClone Investigational Site
Scottsdale, Arizona, United States, 85259
2
ImClone Investigational Site
Los Angeles, California, United States, 90033
3
ImClone Investigational Site
Jacksonville, Florida, United States, 32224
4
ImClone Investigational Site
Atlanta, Georgia, United States, 30322