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Conatumumab/Panitumumab Combination Metastatic Colorectal Cancer Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00630786
First received: February 28, 2008
Last updated: February 5, 2014
Last verified: February 2014
Results First Received: August 6, 2010  
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
Metastatic Colorectal Cancer
Oncology
Interventions: Drug: Panitumumab
Drug: Conatumumab

  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
Participants were enrolled from 12 January 2008 through 6 November 2008

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
Wild-type KRAS Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
Mutant KRAS Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
Unknown KRAS Participants with unknown Kirsten Rat Sarcoma Virus Oncogene (KRAS) type received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.

Participant Flow:   Overall Study
    Wild-type KRAS     Mutant KRAS     Unknown KRAS  
STARTED     19 [1]   25 [2]   9 [3]
Received Study Medication     19     25     8  
COMPLETED     18 [4]   23 [4]   7 [4]
NOT COMPLETED     1     2     2  
Physician Decision                 0                 0                 1  
Withdrawal by Subject                 0                 1                 1  
Lost to Follow-up                 0                 1                 0  
Not specified                 1                 0                 0  
[1] Includes 2 patients enrolled in Part 1 and 17 patients enrolled in Part 2.
[2] Includes 3 patients enrolled in Part 1 and 22 patients enrolled in Part 2.
[3] All patients were enrolled in Part 2.
[4] Completed study defined as participant death



  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
Wild-type KRAS Participants with wild-type Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
Mutant KRAS Participants with mutant Kirsten Rat Sarcoma Virus Oncogene (KRAS) received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
Unknown KRAS Participants with unknown Kirsten Rat Sarcoma Virus Oncogene (KRAS) type received 10 mg/kg conatumumab and 6 mg/kg panitumumab administered on the same day by sequential intravenous (IV) infusions once every 2 weeks until progressive disease, intolerability, withdrawal, or death.
Total Total of all reporting groups

Baseline Measures
    Wild-type KRAS     Mutant KRAS     Unknown KRAS     Total  
Number of Participants  
[units: participants]
  19     25     8     52  
Age  
[units: years]
Mean ± Standard Deviation
  61.53  ± 12.53     64.32  ± 12.35     58.63  ± 13.65     62.42  ± 12.54  
Gender  
[units: participants]
       
Female     13     11     3     27  
Male     6     14     5     25  
Race/Ethnicity, Customized  
[units: participants]
       
Hispanic or Latino     0     1     0     1  
White or Caucasian     16     24     7     47  
Black or African American     3     0     1     4  



  Outcome Measures
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1.  Primary:   Part 1: Number of Participants With Dose-limiting Toxicities   [ Time Frame: 4 weeks ]

2.  Primary:   Number of Participants With an Objective Response   [ Time Frame: Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). ]

3.  Secondary:   Progression-free Survival   [ Time Frame: Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). ]

4.  Secondary:   Overall Survival   [ Time Frame: Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). ]

5.  Secondary:   Number of Participants With Disease Control   [ Time Frame: Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). ]

6.  Secondary:   Time to Response   [ Time Frame: Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). ]

7.  Secondary:   Duation of Response   [ Time Frame: Participants were evaluated for tumor response until radiographic disease progression or until the participant began another anticancer treatment (up to a maximum of 55.6 weeks). ]

8.  Secondary:   Number of Participants With Anti-therapeutic Antibodies   [ Time Frame: Antibody samples were collected at weeks 1, 7, and 23 and every 6 months thereafter during treatment, and at the safety follow-up and follow-up visits. The mean follow-up time was 35.7 weeks. ]

9.  Secondary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 weeks. ]

10.  Secondary:   Number of Participants With Post-baseline Laboratory Values Grade 3 or Higher   [ Time Frame: From first dose of investigational drug until 30 days after the last dose, up to a maximum of 50 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
No text entered.


  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


No publications provided


Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00630786     History of Changes
Other Study ID Numbers: 20060332, 2007-004722-25
Study First Received: February 28, 2008
Results First Received: August 6, 2010
Last Updated: February 5, 2014
Health Authority: Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment
EU: CHMP
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration
United States: Institutional Review Board
United States: Western Institutional Review Board