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Clinical Trial Results:
A Double-Blind, Randomized, Phase III Trial of the Safety and Efficacy of CPP-1X/Sulindac Compared With CPP-1X, Sulindac as Single Agents in Patients with Familial Adenomatous Polyposis (FAP)

Summary
EudraCT number	2012-000427-41
Trial protocol	GB DE NL ES BE
Global end of trial date	25 Nov 2018

Results information
Results version number	v2(current)
This version publication date	25 Jun 2020
First version publication date	18 Dec 2019
Other versions	v1
Version creation reason	Correction of full data set Correct site status
Summary report(s)	FAP-310_SYNOPSIS

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CPP FAP-310

ISRCTN number

US NCT number

NCT01483144

WHO universal trial number (UTN)

Sponsor organisation name

Cancer Prevention Pharmaceuticals

Sponsor organisation address

1760 E River Road Ste 250, Tucson, United States, 85718

Public contact

Andrew Hadlington, Wessex Pharma Services Ltd., 44 7796394475, Andy.Hadlington@wessexpharma.co.uk

Scientific contact

Andrew Hadlington, Wessex Pharma Services Ltd., 5204982275 7796394475, Andy.Hadlington@wessexpharma.co.uk

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

08 Mar 2019

Is this the analysis of the primary completion data?

Yes

Primary completion date

25 Nov 2018

Global end of trial reached?

Yes

Global end of trial date

25 Nov 2018

Was the trial ended prematurely?

Main objective of the trial

The primary objective of this trial is to determine whether the combination of CPP-1X + sulindac is superior to either treatment individually, sulindac alone or CPP-1X alone, in delaying time to the first occurrence of any FAP-related event in the patient as a whole. This includes: 1) FAP related excisional intervention involving the colon, rectum, pouch, duodenum and/or 2) clinically important events which includes progression to more advanced duodenal polyposis, cancer or death.

Protection of trial subjects

Subjects were assessed by endoscopy every 6 months to determine if disease progression had occurred. Hearing was monitored every 12 months. Laboratory assessments for hematology, chemistry and urinalysis were done every 6 months. Subjects were contacted monthly to assess any adverse events. Cardiac function was monitored by EKG every 6 months.

Background therapy

None

Evidence for comparator

The use of sulindac has been endorsed by health organizations and consensus groups for the suppression of colorectal adenomatous polyps in patients with FAP since 1997. Sulindac has been shown to suppress the development of premalignant colonic polyps in patients with familial adenomatous polyposis. Over the past nearly 20 years, several groups have conducted clinical trials of oral eflornithine in the setting of cancer prevention. A Phase III clinical trial of combination daily oral eflornithine and sulindac for three years versus placebo showed a 70% reduction in total, and greater than 90% reduction in advanced and/or multiple, metachronous colon adenomas. In FAP, a study of eflornithine in combination with celecoxib showed that the combination was not different from celecoxib alone for the primary endpoint (duodenal and colorectal polyp number), but it did show statistically significant reductions in the secondary endpoints of polyp volume and global polyp burden.

Actual start date of recruitment

03 Jun 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country