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

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ClinicalTrials.gov Identifier: NCT01256567
Recruitment Status : Completed
First Posted : December 8, 2010
Results First Posted : June 18, 2014
Last Update Posted : June 18, 2014
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Breast Cancer
Metastatic Breast Cancer
Interventions: Biological: Ramucirumab
Drug: Docetaxel

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ramucirumab and Docetaxel Combination

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

Ramucirumab: Ramucirumab (IMC-1121B) administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks.


Participant Flow:   Overall Study
    Ramucirumab and Docetaxel Combination
STARTED   7 
Received at Least 1 Dose of Study Drug   7 
COMPLETED   6 
NOT COMPLETED   1 
Withdrawal by Subject                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ramucirumab and Docetaxel Combination

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

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


Baseline Measures
   Ramucirumab and Docetaxel Combination 
Overall Participants Analyzed 
[Units: Participants]
 7 
Age, Customized 
[Units: Participants]
 
Between 20 and 65 years   6 
>=65 years   1 
Gender 
[Units: Participants]
 
Female   7 
Male   0 
Race/Ethnicity, Customized 
[Units: Participants]
 
Asian   7 
American Indian or Alaska Native   0 
Black or African American   0 
Native Hawaiian or Other Pacific Islander   0 
White   0 
Other   0 
Region of Enrollment 
[Units: Participants]
 
Japan   7 


  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events   [ Time Frame: Baseline up to data cut off (approximately 48.3 weeks) ]

2.  Secondary:   Serum Anti-IMC-1121B Antibody Assessment (Immunogenicity)   [ Time Frame: Baseline up to data cut off (approximately 48.3 weeks) ]

3.  Secondary:   Maximum Concentration (Cmax) of Ramucirumab   [ Time Frame: Day 1 of Cycle 1 and Cycle 4 (cycle=21 days) ]

4.  Secondary:   Area Under the Curve (AUC) of Ramucirumab   [ Time Frame: Day 1 of Cycles 1 and 4 (cycle=21 days) ]

5.  Secondary:   Half Life (t 1/2) of Ramucirumab   [ Time Frame: Day 1 of Cycles 1 and 4 (cycle=21 days) ]

6.  Secondary:   Clearance (Cl) of Ramucirumab   [ Time Frame: Day 1 of Cycle 1 and Cycle 4 (cycle=21 days) ]

7.  Secondary:   Steady State Volume of Distribution (Vss) of Ramucirumab   [ Time Frame: Day 1 of Cycle 1 and 4 (cycle=21 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01256567     History of Changes
Other Study ID Numbers: 14200
CP12-1028 ( Other Identifier: ImClone Systems )
I4T-IE-JVBX ( Other Identifier: Eli Lilly and Company )
First Submitted: December 7, 2010
First Posted: December 8, 2010
Results First Submitted: May 16, 2014
Results First Posted: June 18, 2014
Last Update Posted: June 18, 2014