A Study in Participants With Advanced Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01682135
First received: September 6, 2012
Last updated: July 15, 2016
Last verified: July 2016
Results First Received: March 14, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Solid Tumor
Intervention: Biological: Ramucirumab

  Participant Flow
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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
Participant study completion is defined as a participant either completing all 6 cycles of study drug or discontinuing study drug due to dose-limiting toxicities (DLT), then completing all required End-of-Therapy and End-of-Study assessments.

Reporting Groups
  Description
Cohort 1 - 6 mg/kg/2w Ramucirumab 6 milligram per kilogram (mg/kg) ramucirumab administered intravenously (IV) every 2 weeks (w) for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2. After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met.
Cohort 2 - 10 mg/kg/3w Ramucirumab 10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3. After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met.
Cohort 3 - 8 mg/kg/2w Ramucirumab 8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met.

Participant Flow:   Overall Study
    Cohort 1 - 6 mg/kg/2w Ramucirumab     Cohort 2 - 10 mg/kg/3w Ramucirumab     Cohort 3 - 8 mg/kg/2w Ramucirumab  
STARTED     6     10     12  
Received at Least 1 Dose of Study Drug     6     10     12  
COMPLETED     6     10     12  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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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.
All randomized participants who received at least one dose of study drug.

Reporting Groups
  Description
Cohort 1 - 6 mg/kg/2w Ramucirumab 6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle) followed by dose escalation to Cohort 2. When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
Cohort 2 - 10 mg/kg/3w Ramucirumab 10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle) followed by dose escalation to Cohort 3. When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
Cohort 3 - 8 mg/kg/2w Ramucirumab 8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
Total Total of all reporting groups

Baseline Measures
    Cohort 1 - 6 mg/kg/2w Ramucirumab     Cohort 2 - 10 mg/kg/3w Ramucirumab     Cohort 3 - 8 mg/kg/2w Ramucirumab     Total  
Number of Participants  
[units: participants]
  6     10     12     28  
Age  
[units: Years]
Mean (Standard Deviation)
  51.20  (9.060)     52.92  (9.509)     58.18  (9.444)     54.80  (9.536)  
Gender  
[units: Participants]
       
Female     4     3     7     14  
Male     2     7     5     14  
Race (NIH/OMB)  
[units: Participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     6     10     12     28  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     0     0     0     0  
White     0     0     0     0  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: Participants]
       
China     6     10     12     28  



  Outcome Measures
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1.  Primary:   Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious Adverse Events (SAEs)   [ Time Frame: Baseline through Study Completion (Up to 12 Weeks) ]

2.  Primary:   Pharmacokinetics: Maximum Concentration (Cmax) of Ramucirumab   [ Time Frame: Cycle 1 & 2: Predose, End of Infusion, 0.5 hour (h) ,1h, 2h, 4h, 8h, 24h, 48h,72h or 96h, 168h, 264h, and 336h Postdose (and 504h Postdose Cohort 2 only) ]

3.  Primary:   Pharmacokinetics: Minimum Concentration (Cmin) of Ramucirumab   [ Time Frame: Cycle 2-5: Predose ]

4.  Primary:   Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Ramucirumab   [ Time Frame: Cycle 1 & 2: Predose, End of Infusion, 0.5 hour (h) ,1h, 2h, 4h, 8h, 24h, 48h,72h or 96h, 168h, 264h, and 336h Postdose (and 504h Postdose Cohort 2 only) ]

5.  Secondary:   Duration of Response   [ Time Frame: Time Between Meeting Response Criteria and Progressive Disease or Death Due to Any Cause (Up to 10 Weeks) ]

6.  Secondary:   Duration of Stable Disease (SD)   [ Time Frame: Baseline to Progressive Disease or Death Due to Any Cause (Up to 10 Weeks) ]

7.  Secondary:   Time to Disease Progression   [ Time Frame: Baseline to Progressive Disease (Up to 10 Weeks) ]

8.  Secondary:   Number of Participants With Anti-Ramucirumab Antibodies   [ Time Frame: Cycle 1: Pre-infusion, Cycle 2: Pre-infusion, Cycle 3: Pre-infusion ]

9.  Secondary:   Number of Participants With Best Objective Response (BOR)   [ Time Frame: Baseline to Progressive Disease or Participant Stopped Study (Up to 10 Weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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: NCT01682135     History of Changes
Other Study ID Numbers: 14139
I4T-CR-JVBU ( Other Identifier: Eli Lilly and Company )
Study First Received: September 6, 2012
Results First Received: March 14, 2016
Last Updated: July 15, 2016
Health Authority: China: Food and Drug Administration
United States: Food and Drug Administration