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

Effect of Panitumumab on the Pharmacokinetics of Irinotecan

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00563316
First received: November 21, 2007
Last updated: March 14, 2016
Last verified: March 2016
Results First Received: March 14, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Colorectal Cancer
Interventions: Drug: Panitumumab
Drug: Irinotecan

  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
This study was conducted at 6 sites in the United States and Canada. The first patient enrolled on 28 March 2008 and the last patient enrolled on 30 January 2009. Results are reported up until the data cut-off date of 16 July 2009.

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
Panitumumab + Irinotecan Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.

Participant Flow:   Overall Study
    Panitumumab + Irinotecan  
STARTED     28  
Received Investigational Product     27  
COMPLETED     16  
NOT COMPLETED     12  
Adverse Event                 2  
Physician Decision                 1  
Lost to Follow-up                 2  
Death                 1  
On-going in study as of 16 July 2009.                 5  
Other                 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.
Safety analysis set (all participants who received at least 1 dose of panitumumab or irinotecan)

Reporting Groups
  Description
Panitumumab + Irinotecan Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.

Baseline Measures
    Panitumumab + Irinotecan  
Number of Participants  
[units: participants]
  27  
Age  
[units: years]
Mean (Standard Deviation)
  58.1  (10.7)  
Gender  
[units: participants]
 
Female     9  
Male     18  
Race/Ethnicity, Customized  
[units: participants]
 
White or Caucasian     17  
Black or African American     0  
Hispanic or Latino     0  
Asian     8  
Japanese     1  
American Indian or Alaska Native     0  
Native Hawaiian or Other Pacific Islander     0  
Aborigine     0  
Other     1  
Primary Tumor Type  
[units: participants]
 
Colon Cancer     17  
Rectal Cancer     10  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Observed Plasma Concentration (Cmax) of Irinotecan   [ Time Frame: Predose and at 10 minutes, and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours after the end of the irinotecan infusion at cycle 1 (irinotecan alone, week 1 day 1) and cycle 2 (irinotecan with panitumumab, week 3, day 1). ]

2.  Primary:   Area Under the Plasma Concentration-time Curve From the Time of Dosing to Infinity (AUCinf) for Irinotecan   [ Time Frame: Predose and at 10 minutes, and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours after the end of the irinotecan infusion at cycle 1 (irinotecan alone, week 1 day 1) and cycle 2 (irinotecan with panitumumab, week 3, day 1). ]

3.  Primary:   Area Under the Plasma Concentration-time Curve From the Time of the Last Quantifiable Concentration (AUClast) for Irinotecan   [ Time Frame: Predose and at 10 minutes, and 0.5, 1, 2, 4, 8, 24, 48, and 72 hours after the end of the irinotecan infusion at cycle 1 (irinotecan alone, week 1 day 1) and cycle 2 (irinotecan with panitumumab, week 3, day 1). ]

4.  Primary:   Number of Participants With Clinically Significant Adverse Events (AEs)   [ Time Frame: The reporting time frame for Adverse Events is from first dose date to 30 days since the last dose date, until the data cut-off date of 16 July 2009. The median time frame is 5.7 months. ]


  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: Study Director
Organization: Amgen Inc.
phone: 866-572-6436


Publications:

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00563316     History of Changes
Other Study ID Numbers: 20062010
Study First Received: November 21, 2007
Results First Received: March 14, 2016
Last Updated: March 14, 2016
Health Authority: Canada: Health Canada
Canada: Institutional Review Board
United States: Food and Drug Administration
United States: Institutional Review Board
United States: Quorom Institutional Review Board