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PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00446446
First received: March 8, 2007
Last updated: June 8, 2016
Last verified: June 2016
Results First Received: February 1, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Cancer
Carcinoma
Head and Neck Cancer
Metastases
Metastatic Cancer
Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck
Oncology
Squamous Cell Carcinoma
Tumors
Intervention: Drug: Panitumumab

  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
A total of 65 patients with metastatic or recurrent squamous cell carcinoma of the head and neck were screened of whom 52 were enrolled at 22 study centers in North America (20 study centers) and Australia (2 study centers) between October 2007 and December 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Results are reported for the primary analysis with a data cut-off date of 16 December 2010.

Reporting Groups
  Description
Panitumumab Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.

Participant Flow:   Overall Study
    Panitumumab  
STARTED     52  
COMPLETED     28 [1]
NOT COMPLETED     24  
Death                 10  
Withdrawal by Subject                 6  
Other                 4  
Disease Progession                 2  
Adverse Event                 1  
On Treatment at Time of Data Cut-off                 1  
[1] Participants who completed the 60-day safety visit



  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 Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.

Baseline Measures
    Panitumumab  
Number of Participants  
[units: participants]
  52  
Age  
[units: years]
Mean (Standard Deviation)
  59.8  (8.9)  
Gender  
[units: participants]
 
Female     16  
Male     36  
Race/Ethnicity, Customized  
[units: participants]
 
White or Caucasian     48  
Black or African American     3  
Other     1  
Primary Tumor Site  
[units: participants]
 
Oropharynx     18  
Hypopharynx     1  
Larynx     13  
Oral Cavity     20  
Cancer Stage of Diagnosis  
[units: participants]
 
Locally recurrent disease without metastases     11  
Metastatic     41  
Prior Treatment for Head and neck Cancer [1]
[units: participants]
 
Prior chemotherapy     52  
Prior radiotherapy     48  
Prior surgery     46  
Eastern Cooperative Oncology Group (ECOG) Performance Status [2]
[units: participants]
 
0 = (Fully Active)     20  
1 = (Restrictive but Ambulatory)     31  
2 = (Ambulatory unable to Work)     1  
[1] Participants may have received more than one prior treatment.
[2]

A scale to assess a patient's disease status. 0 = Fully active, able to carry out all pre-disease performance without restriction;

  1. = Restricted in physically strenuous activity, ambulatory and able to carry out work of a light nature;
  2. = Ambulatory and capable of all self care, unable to carry out any work activities. Up and about > 50% of waking hours;
  3. = Capable of only limited self-care, confined to bed or chair > 50% of waking hours;
  4. = Completely disabled, confined to bed or chair;
  5. = Dead.



  Outcome Measures
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1.  Primary:   Objective Response Rate   [ Time Frame: From first dose of study drug until the data cut-off date of 16 December 2010. Median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks). ]

2.  Secondary:   Time to Response   [ Time Frame: From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks) ]

3.  Secondary:   Duration of Response   [ Time Frame: From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks) ]

4.  Secondary:   Rate of Disease Control   [ Time Frame: From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks). ]

5.  Secondary:   Time to Progression   [ Time Frame: From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks). ]

6.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks). ]

7.  Secondary:   Overall Survival (OS)   [ Time Frame: From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks). ]

8.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: The reporting time frame for Adverse Events is from first dose date to 30 days since the last dose date date. The median time frame is 2.4 months. ]


  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


Publications:
Spigel D. Second-line panitumumab monotherapy for treatment of advanced head and neck cancer: the PRISM Trial. Community Oncology. 2008;5(Supp 11):1-4.


Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00446446     History of Changes
Other Study ID Numbers: 20062088
Study First Received: March 8, 2007
Results First Received: February 1, 2016
Last Updated: June 8, 2016
Health Authority: United States: Food and Drug Administration