A Study of Ramucirumab (IMC-1121B) in Participants With Breast Cancer

NCT ID: NCT01256567

Last Updated: 2014-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2013-02-28

Brief Summary

The primary objective of this study is to investigate the safety and tolerability of the anti-VEGFR-2 monoclonal antibody ramucirumab drug product in combination with docetaxel in Japanese participants with metastatic, or locally advanced breast cancer, with the aim of confirming the recommended dose of ramucirumab drug product (DP) in combination with docetaxel.

Conditions

Breast Cancer; Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ramucirumab and docetaxel combination

Group Type: EXPERIMENTAL

Ramucirumab

Intervention Type: BIOLOGICAL

Ramucirumab administered as an intravenous (I.V.) infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks.

Docetaxel

Intervention Type: DRUG

Docetaxel administered by intravenous (I.V.) infusion at a dose of 75 milligrams per square meter (mg/m\^2) every 3 weeks.

Interventions

Ramucirumab

Ramucirumab administered as an intravenous (I.V.) infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks.

Intervention Type: BIOLOGICAL

Docetaxel

Docetaxel administered by intravenous (I.V.) infusion at a dose of 75 milligrams per square meter (mg/m\^2) every 3 weeks.

Intervention Type: DRUG

Other Intervention Names

IMC-1121B; LY3009806

Eligibility Criteria

Inclusion Criteria

• The participant is Japanese
• The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• The participant has a histopathologically or cytologically confirmed diagnosis of breast adenocarcinoma that is now metastatic or locally-recurrent and inoperable with curative intent
• The participant has measurable and/or non-measurable disease
• The participants' primary and/or metastatic tumor is Human Epidermal Growth Factor Receptor 2 (HER2) negative
• The participant received neo adjuvant or adjuvant taxane therapy ≥ 6 months prior to the study
• The participant received neo adjuvant or adjuvant biologic therapy ≥ 6 weeks prior to the study
• The participant completed all prior radiotherapy ≥ 3 weeks prior to the study registration date
• The participant received prior hormonal therapy for breast cancer in the neo adjuvant, adjuvant,and/or the metastatic setting ≥ 2 weeks prior to the study registration date
• The participant's left ventricular ejection fraction (LVEF) is within normal ranges
• The participant has adequate hematologic, hepatic, and coagulation function.
• Eligible participants of reproductive potential agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and for 12 weeks after the last dose of study medication

Exclusion Criteria

• The participant has a concurrent active malignancy other than breast adenocarcinoma, adequately treated non-melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm. Participants with previous treatment of malignancy is eligible, provided that she has been disease free for >3 years
• The participant has a known sensitivity to docetaxel
• The participant has a known sensitivity to agents of similar biologic composition as ramucirumab
• The participant has a history of chronic diarrheal disease within 6 months prior to the study registration date
• The participant has received irradiation to a major bone marrow area within 30 days prior to the study registration date
• The participant has received any experimental agents within 4 weeks prior to the study registration date
• The participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
• The participant has Grade 3-4 bleeding within 3 months prior to the study registration date
• The participant has an ongoing or active infection requiring antibiotic, antifungal, or antiviral therapy
• The participant has uncontrolled hypertension, symptomatic congestive heart failure, psychiatric illness, or any other serious uncontrolled medical disorders
• The participant has brain metastases
• The participant has known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness
• The participant is pregnant or lactating
• The participant has not fully recovered from effects of prior chemotherapy
• The participant has undergone major surgery within 28 days prior to the study registration date

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

ImClone Investigational Site

Hidaka, , Japan

ImClone Investigational Site

Matsuyama, , Japan

Imclone Investigational Site

Nagoya, , Japan

ImClone Investigational Site

Osaka, , Japan

Countries

Japan

Other Identifiers

CP12-1028

Identifier Type: OTHER

Identifier Source: secondary_id

I4T-IE-JVBX

Identifier Type: OTHER

Identifier Source: secondary_id

14200

Identifier Type: -

Identifier Source: org_study_id