- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01256567
A Study of Ramucirumab (IMC-1121B) in Participants With Breast Cancer
May 16, 2014 updated by: Eli Lilly and Company
A Phase 1b Study of Docetaxel in Combination With Ramucirumab (IMC-1121B) Drug Product in Patients With Locally Advanced or Metastatic Breast Cancer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hidaka, Japan, 350-1298
- ImClone Investigational Site
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Matsuyama, Japan, 790-0007
- ImClone Investigational Site
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Nagoya, Japan, 464-8681
- ImClone Investigational Site
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Osaka, Japan, 540-0006
- ImClone Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ramucirumab and docetaxel combination
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Ramucirumab administered as an intravenous (I.V.) infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks.
Other Names:
Docetaxel administered by intravenous (I.V.) infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events
Time Frame: Baseline up to data cut off (approximately 48.3 weeks)
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Number participants with drug related dose-limiting toxicities (DLT) during Cycle 1; ramucirumab related: treatment-emergent adverse events (TEAE), serious adverse events (SAE), Grade 3 or higher TEAE, or TEAE leading to discontinuation or ramucirumab dose modification.
DLT=G4 neutropenia >7days; G ≥3 neutropenia with fever ≥38.5°C requiring IV antibiotics or bacteriemia or sepsis; G4 thrombocytopenia; G ≥3 thrombocytopenia with bleeding requiring platelets; G≥3 prothrombin time and/or partial thromboplastin time in absence of anticoagulants; G≥2 hyperbilirubinemia ≥5 days; QTc >500 milliseconds (ms) or increase ≥100 ms or arrhythmia; G≥4 or uncontrollable hypertension; G≥3 nonhematologic toxicity (excluding G3: hypersensitivity, injection-site reaction, arthralgia/myalgia, asthenia/fatigue, diarrhea without loperamide therapy, nausea/vomiting without antiemetics, transient G3/4 elevation of aminotransferases); treatment delay >2 weeks due to toxicity.
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Baseline up to data cut off (approximately 48.3 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum Anti-IMC-1121B Antibody Assessment (Immunogenicity)
Time Frame: Baseline up to data cut off (approximately 48.3 weeks)
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The number of participants with a positive anti-IMC-1121B titer at any point during the study.
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Baseline up to data cut off (approximately 48.3 weeks)
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Maximum Concentration (Cmax) of Ramucirumab
Time Frame: Day 1 of Cycle 1 and Cycle 4 (cycle=21 days)
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Cmax (Cycle 1) and Cmax at steady state (Cmax,ss, Cycle 4) of ramucirumab are provided.
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Day 1 of Cycle 1 and Cycle 4 (cycle=21 days)
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Area Under the Curve (AUC) of Ramucirumab
Time Frame: Day 1 of Cycles 1 and 4 (cycle=21 days)
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AUC from time zero to infinity (AUC[0-inf], Cycle 1) and at steady state (AUC tau, Cycle 4) of ramucirumab are provided.
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Day 1 of Cycles 1 and 4 (cycle=21 days)
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Half Life (t 1/2) of Ramucirumab
Time Frame: Day 1 of Cycles 1 and 4 (cycle=21 days)
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Day 1 of Cycles 1 and 4 (cycle=21 days)
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Clearance (Cl) of Ramucirumab
Time Frame: Day 1 of Cycle 1 and Cycle 4 (cycle=21 days)
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Clearance (Cycle 1) and at steady state (Clss, Cycle 4) of ramucirumab are provided.
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Day 1 of Cycle 1 and Cycle 4 (cycle=21 days)
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Steady State Volume of Distribution (Vss) of Ramucirumab
Time Frame: Day 1 of Cycle 1 and 4 (cycle=21 days)
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Day 1 of Cycle 1 and 4 (cycle=21 days)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
December 7, 2010
First Submitted That Met QC Criteria
December 7, 2010
First Posted (Estimate)
December 8, 2010
Study Record Updates
Last Update Posted (Estimate)
June 18, 2014
Last Update Submitted That Met QC Criteria
May 16, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14200
- CP12-1028 (Other Identifier: ImClone Systems)
- I4T-IE-JVBX (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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