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 16, 2014
Last verified: May 2014
Results First Received: May 16, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: 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  
Number of Participants  
[units: participants]
  24     16     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     14     10     24  
>=65 years     10     6     16  
Gender  
[units: participants]
     
Female     13     9     22  
Male     11     7     18  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     0     1  
Not Hispanic or Latino     23     16     39  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     1     2  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     22     15     37  
More than one race     1     0     1  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     24     16     40  



  Outcome Measures
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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 posted.   Anticipated Posting Date:   05/2015   Safety Issue:   Yes

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 posted.   Anticipated Posting Date:   05/2015   Safety Issue:   Yes


  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 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


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01515306     History of Changes
Other Study ID Numbers: 14432, I4T-IE-JVCA, CP12-1032
Study First Received: January 18, 2012
Results First Received: May 16, 2014
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration