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Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment (PRECEPT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00411450
First received: December 12, 2006
Last updated: January 15, 2016
Last verified: January 2016
Results First Received: January 15, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Colon Cancer
Colorectal Cancer
Rectal Cancer
Cancer
Metastatic Cancer
Metastatic Colorectal Cancer
Oncology
Interventions: Biological: Panitumumab
Drug: FOLFIRI

  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
This study was conducted at 56 sites in the United States. The first patient enrolled on 30 November 2006 and the last patient enrolled on 07 January 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants recived second-line therapy until disease progression, intolerability, death, or study withdrawal. Participants completed a safety visit 4 weeks after the last dose. Participants were followed for survival every 12 weeks from the safety visit until the end of the study; the data cut-off date for results is 2 January 2009.

Reporting Groups
  Description
Panitumumab Plus FOLFIRI Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.

Participant Flow:   Overall Study
    Panitumumab Plus FOLFIRI  
STARTED     116  
Received Treatment     115  
COMPLETED     113 [1]
NOT COMPLETED     3  
Ongoing at time of data cut-off.                 3  
[1] Ended second-line treatment



  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.
No text entered.

Reporting Groups
  Description
Panitumumab Plus FOLFIRI Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.

Baseline Measures
    Panitumumab Plus FOLFIRI  
Number of Participants  
[units: participants]
  116  
Age  
[units: years]
Mean (Standard Deviation)
  60.0  (12.5)  
Gender  
[units: participants]
 
Female     41  
Male     75  
Race/Ethnicity, Customized  
[units: participants]
 
White or Caucasian     94  
Black or African American     13  
Hispanic or Latino     8  
Asian     1  
Kirsten Rat Sarcoma Gene (KRAS) Mutation Status [1]
[units: participants]
 
Wild-type     65  
Mutant     45  
Unevaluable     6  
[1] Unevaluable includes missing, lack of tissue sample, invalid or failed test results.



  Outcome Measures
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1.  Primary:   Objective Response Rate at Weeks 17 and 25   [ Time Frame: Week 17 and Week 25 ]

2.  Primary:   Best Response During Second-Line Treatment   [ Time Frame: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks. ]

3.  Primary:   Progression-free Survival Rate at Weeks 17 and 25   [ Time Frame: Week 17 and Week 25 ]

4.  Primary:   Progression-free Survival Time   [ Time Frame: From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks. ]

5.  Primary:   Disease Control Rate at Weeks 17 and 25   [ Time Frame: Week 17 and Week 25 ]

6.  Primary:   Duration of Response   [ Time Frame: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks. ]

7.  Primary:   Overall Survival   [ Time Frame: From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks. ]

8.  Primary:   Time to Treatment Failure   [ Time Frame: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks. ]

9.  Primary:   Time to Progression   [ Time Frame: From Study Day 1 until the data cut-off date of 2 January 2009; median follow-up time was 39 weeks, with a maximum of 93 weeks. ]

10.  Primary:   Time to Response   [ Time Frame: Tumor response was assessed at Weeks 9, 17, 25, and 33, and once every 12 weeks thereafter until the end of second-line treatment; maximum time on treatment was 77 weeks. ]

11.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months. ]

12.  Secondary:   Number of Participants With Grade 4 Laboratory Toxicities   [ Time Frame: From the first dose date to 30 days after the last dose date. The median time frame is 4.5 months. ]

13.  Secondary:   Number of Participants Who Developed Antibodies to Panitumumab   [ Time Frame: Prior to first dose and 28 days after the last dose of second-line treatment ]


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


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00411450     History of Changes
Other Study ID Numbers: 20060277
Study First Received: December 12, 2006
Results First Received: January 15, 2016
Last Updated: January 15, 2016
Health Authority: United States: Food and Drug Administration