A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients (FAPEST)

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jewel Samadder, University of Utah
ClinicalTrials.gov Identifier:
NCT01187901
First received: August 3, 2010
Last updated: May 10, 2016
Last verified: May 2016
Results First Received: May 10, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Adenomatous Polyposis Coli
Interventions: Drug: Erlotinib
Drug: Sulindac
Drug: Placebo A
Drug: Placebo B

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sulindac-erlotinib Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
Placebo Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months

Participant Flow:   Overall Study
    Sulindac-erlotinib     Placebo  
STARTED     46     46  
COMPLETED     37     36  
NOT COMPLETED     9     10  
Protocol Violation                 1                 0  
Lost to Follow-up                 1                 2  
Unrelated Health Reasons                 1                 2  
Suspected Allergic Reaction                 1                 1  
Adverse Event                 3                 0  
No Endpoint due to Early Study Halt                 2                 3  
Pregnancy                 0                 2  



  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.
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Reporting Groups
  Description
Sulindac-erlotinib Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
Placebo Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
Total Total of all reporting groups

Baseline Measures
    Sulindac-erlotinib     Placebo     Total  
Number of Participants  
[units: participants]
  46     46     92  
Age  
[units: years]
Mean (Standard Deviation)
  42  (14)     41  (14)     41  (14)  
Gender  
[units: participants]
     
Female     28     28     56  
Male     18     18     36  
Familial Adenomatous Polyposis (FAP) Status  
[units: participants]
     
Classic FAP     32     32     64  
Attenuated FAP     14     14     28  



  Outcome Measures
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1.  Primary:   Change in Duodenal Polyp Burden From Baseline to 6 Months   [ Time Frame: Baseline and 6 months ]

2.  Secondary:   Change in Duodenal Polyp Burden From Baseline to 6 Months in Classic Familial Adenomatous Polyposis (FAP) Participants   [ Time Frame: Baseline and 6 months ]

3.  Secondary:   Change in Duodenal Polyp Burden From Baseline to 6 Months in Attenuated FAP Participants   [ Time Frame: Baseline and 6 months ]

4.  Secondary:   Change in Number of Duodenal Polyps From Baseline to 6 Months   [ Time Frame: Baseline and 6 months ]

5.  Secondary:   Change in Number of Duodenal Polyps From Baseline to 6 Months in Classic FAP Participants   [ Time Frame: Baseline and 6 months ]

6.  Secondary:   Change in Number of Duodenal Polyps From Baseline to 6 Months in Attenuated FAP Participants   [ Time Frame: Baseline and 6 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
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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 NOT 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.


Results Point of Contact:  
Name/Title: N. Jewel Samadder
Organization: University of Utah
phone: 801-213-4211
e-mail: jewel.samadder@hsc.utah.edu


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

Responsible Party: Jewel Samadder, University of Utah
ClinicalTrials.gov Identifier: NCT01187901     History of Changes
Other Study ID Numbers: 00039278
P01CA073992 ( US NIH Grant/Contract Award Number )
Study First Received: August 3, 2010
Results First Received: May 10, 2016
Last Updated: May 10, 2016
Health Authority: United States: Food and Drug Administration