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A Study of Ramucirumab (IMC-1121B) and Paclitaxel in Participants With Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01515306
First received: January 18, 2012
Last updated: May 25, 2017
Last verified: May 2017
Results First Received: May 16, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Malignant Solid Tumor
Interventions: Biological: ramucirumab (IMC-1121B)
Drug: paclitaxel

  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
No text entered.

Reporting Groups
  Description
Part A: Paclitaxel and Ramucirumab (IMC-1121B)

Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.

Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.

Cycle 3 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of each 4-week cycle.

Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel

Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.

Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.

*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A.


Participant Flow:   Overall Study
    Part A: Paclitaxel and Ramucirumab (IMC-1121B)   Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel
STARTED   24   16 
Received at Least 1 Dose of Study Drug   24   16 
Drug-Drug Interaction Population   21 [1]   0 [2] 
COMPLETED   12 [3]   2 
NOT COMPLETED   12   14 
Adverse Event                2                0 
Progressive Disease                1                0 
Ongoing receiving treatment                9                14 
[1] Completed Cycle 1 Day 1 and Cycle 2 Day 1 treatment.
[2] Drug-drug interaction was only assessed in Part A.
[3] Completed the required treatment in Cycle 1 Day 1 and Cycle 2 Day 1 and assessment.



  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 participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Part A: Paclitaxel and Ramucirumab (IMC-1121B)

Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.

Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.

Cycle 3 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of each 4-week cycle.

Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel

Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.

Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.

*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A.

Total Total of all reporting groups

Baseline Measures
   Part A: Paclitaxel and Ramucirumab (IMC-1121B)   Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   16   40 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      14  58.3%      10  62.5%      24  60.0% 
>=65 years      10  41.7%      6  37.5%      16  40.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      13  54.2%      9  56.3%      22  55.0% 
Male      11  45.8%      7  43.8%      18  45.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      1   4.2%      0   0.0%      1   2.5% 
Not Hispanic or Latino      23  95.8%      16 100.0%      39  97.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   4.2%      1   6.3%      2   5.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      0   0.0% 
White      22  91.7%      15  93.8%      37  92.5% 
More than one race      1   4.2%      0   0.0%      1   2.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   24   16   40 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 1   [ Time Frame: Cycle 1: 0, 1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion ]

2.  Primary:   Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Paclitaxel From Time Zero to Infinity [AUC(0-∞)] in Cycle 2   [ Time Frame: Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion ]

3.  Primary:   Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 1   [ Time Frame: Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72 and 168 hours post paclitaxel infusion ]

4.  Primary:   Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Paclitaxel in Cycle 2   [ Time Frame: Cycle 2: -1, 0, 1, 1.5, 2, 5, 7, 24, 48, 72, 96, 168, 264 and 336 hours post paclitaxel infusion ]

5.  Primary:   Part B: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] as Monotherapy   [ Time Frame: Cycle 1: 0,1, 1.5, 2, 5, 7, 24, 48, 72,168, 264, 336, 408, and 504 hours post ramucirumab infusion ]

6.  Secondary:   Part A: Pharmacokinetics - Dose-Normalized Area Under the Concentration Versus Time Curve of Ramucirumab From Time Zero to Infinity [AUC(0-∞)] in the Presence of Paclitaxel   [ Time Frame: Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion ]

7.  Secondary:   Part A: Pharmacokinetics - Dose-Normalized Maximum Observed Drug Concentration (Cmax) of Ramucirumab in the Presence of Paclitaxel   [ Time Frame: Cycle 2: 0, 1, 2, 2.5, 3, 6, 8, 25, 49, 73, 97, 169, 265 and 337 hours post ramucirumab infusion ]

8.  Secondary:   Part A: Immunogenicity of Ramucirumab in Combination With Paclitaxel - Incidence of Anti-Ramucirumab Antibodies   [ Time Frame: -1 hour on Day 1 of Cycle 2, and 30 days after last dose of study drug ]
Results not yet reported.   Anticipated Reporting Date:   06/2017  

9.  Secondary:   Part B: Immunogenicity of Ramucirumab as Monotherapy - Incidence of Anti-Ramucirumab Antibodies   [ Time Frame: 0 hour on Day 1 of Cycle 1, and 30 days after last dose of study drug ]
Results not yet reported.   Anticipated Reporting Date:   06/2017  


  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
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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 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: NCT01515306     History of Changes
Other Study ID Numbers: 14432
I4T-IE-JVCA ( Other Identifier: Eli Lilly and Company )
CP12-1032 ( Other Identifier: ImClone Systems )
Study First Received: January 18, 2012
Results First Received: May 16, 2014
Last Updated: May 25, 2017