Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study of Ramucirumab (IMC-1121B) With Paclitaxel and Carboplatin in Non-small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00735696
First received: August 13, 2008
Last updated: December 17, 2014
Last verified: December 2014
Results First Received: December 17, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non Small Cell Lung Cancer
Interventions: Biological: Ramucirumab
Drug: Paclitaxel
Drug: Carboplatin

  Participant Flow
  Hide 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
52 participants signed informed consent

Reporting Groups
  Description
Ramucirumab + Paclitaxel + Carboplatin

ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.

paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.

carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.

Participants received ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants continued to receive ramucirumab monotherapy every 3 weeks, provided there was ongoing evidence of benefit upon review every 6 weeks.


Participant Flow:   Overall Study
    Ramucirumab + Paclitaxel + Carboplatin
STARTED   41 
Received Any Quantity of Study Drug   40 
COMPLETED   39 
NOT COMPLETED   2 
Withdrawal by Subject                1 
Enrolled but never Treated                1 



  Baseline Characteristics
  Hide 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.
Modified intent to treat population (mITT): All participants who received any quantity of study drug.

Reporting Groups
  Description
Ramucirumab + Paclitaxel + Carboplatin

ramucirumab: 10 mg/kg administered intravenously on day 1 of each 21-day cycle.

paclitaxel: 200 mg/m^2 administered intravenously on day 1 of each 21-day cycle for up to six cycles.

carboplatin: administered intravenously on day 1 of each 21-day cycle, dose calculated based on the participant's body weight.

Participants will receive ramucirumab in combination with paclitaxel and carboplatin until disease progression, the development of an unacceptable toxicity, or other withdrawal criteria, for up to six cycles (3 weeks per cycle). In the absence of any withdrawal criteria, participants will continue to receive ramucirumab monotherapy every 3 weeks, provided there is ongoing evidence of benefit upon review every 6 weeks.


Baseline Measures
   Ramucirumab + Paclitaxel + Carboplatin 
Overall Participants Analyzed 
[Units: Participants]
 40 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   27 
>=65 years   13 
Gender 
[Units: Participants]
 
Female   25 
Male   15 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   3 
Not Hispanic or Latino   37 
Unknown or Not Reported   0 
Race/Ethnicity, Customized 
[Units: Participants]
 
White   34 
Black or African American   4 
Asian   2 
Region of Enrollment 
[Units: Participants]
 
United States   36 
United Kingdom   4 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Who Are Progression-free (PFS) at 6 Months   [ Time Frame: 6 months ]

2.  Secondary:   Summary of Participants Reporting Adverse Events   [ Time Frame: Baseline up to 32.5 months ]

3.  Secondary:   Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate ([ORR])   [ Time Frame: First dose to measured progressive disease or death due to any cause up to 32.5 months ]

4.  Secondary:   Duration of Response   [ Time Frame: First dose up to 32.5 months ]

5.  Secondary:   Overall Survival (OS) at 1 Year   [ Time Frame: First dose to 1 year ]

6.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: First dose to measured progressive disease or death due to any cause, up to 32.5 months ]

7.  Secondary:   Overall Survival (OS)   [ Time Frame: First dose to death due to any cause, up to 32.5 months ]

8.  Secondary:   Serum Anti-Ramucirumab Antibody Assessment   [ Time Frame: Week 15 (Cycle 5) ]

9.  Secondary:   Maximum Concentration of Ramucirumab (Cmax)   [ Time Frame: Week 18 (Cycle 6), at 1-Hour Post End of Infusion ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide 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: NCT00735696     History of Changes
Other Study ID Numbers: 13914
2007-006715-22 ( EudraCT Number )
CP12-0708 ( Other Identifier: ImClone Systems )
I4T-IE-JVBJ ( Other Identifier: Eli Lilly and Company )
Study First Received: August 13, 2008
Results First Received: December 17, 2014
Last Updated: December 17, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United Kingdom: Medicines and Healthcare Products Regulatory Agency