Effect of EPA-FFA on Polypectomy in Familial Adenomatous Polyposis

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    204
  • sponsor
    S.L.A. Pharma AG
Updated on 26 July 2021
Investigator
Justin Slagel, CEO
Primary Contact
Ospedale Casa Sollievo della Sofferenza (0.0 mi away) Contact
+28 other location
aspirin
colectomy
eicosapentaenoic acid
rectal anastomosis

Summary

2 Year randomised, double-blind, placebo-controlled, parallel group study to determine the safety and efficacy of EPA-FFA gastro resistant capsules in FAP.

Description

The purpose of this Phase III study is to determine whether Eicosapentaenoic acid-free fatty acid is a safe and well tolerated treatment in reducing the number of polypectomies FAP patients with an APC gene mutation have over a 2 year treatment period and to assess the effect that this has on clinical disease progression. Planned Sample Size This study will enrol 204 subjects (102 subjects per treatment group). Primary Objective is to determine the efficacy of EPA-FFA gastro-resistant capsules in patients with FAP in reducing polypectomy.

Secondary objectives is to evaluate the clinical disease progression and the long-term safety and tolerability of EPA-FFA.

Details
Condition APC gene, Colorectal Cancer, Adenomatous Polyposis Coli, Hereditary Neoplastic Syndrome, Colon Cancer Screening, Colon cancer; rectal cancer, Hereditary Cancer Syndromes, familial adenomatous polyposis, familial adenomatous polyposis coli
Treatment Placebo, Eicosapentaenoic acid free fatty acid (EPA-FFA)
Clinical Study IdentifierNCT03806426
SponsorS.L.A. Pharma AG
Last Modified on26 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Must give written informed consent
Male or female subjects, 18 to 65 years of age
Known diagnosis of FAP defined as those with a pathogenic APC mutation and have had a previous colectomy with ileo-rectal anastomosis
Subjects must have a preserved rectum
Classified stage 1-3 on InSiGHT Polyposis Staging System (IPSS)
Subjects must show a willingness to abstain from regular use of non-steroidal anti-inflammatory medication for the trial. A cardioprotective dose of aspirin (75mg-100mg) will be permitted

Exclusion Criteria

In subjects with previous ileo-rectal anastomosis 20 polyps > 5mm in the rectum
Subjects with an ileo-anal pouch
Subjects unwilling to have regular endoscopic examination
Subjects who are due to undergo gastro-intestinal surgery related to FAP
History of invasive carcinoma in the past 3 years
History of pelvic radiation
Known allergic reaction or intolerant to fish or fish oils
Known allergic reaction to excipients of IMP and placebo
Subjects who are pregnant or breast-feeding at screening
Subjects taking aspirin or other non-steroidal anti-inflammatory drugs on a regular basis other than low dose (75mg-100mg) cardioprotective dose
Subjects taking NSAIDs regularly in the 3 months prior to entry (other than low dose aspirin)
Subjects who are taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study. Subjects previously taking fish oil must have a washout period of 2 months prior to study enrolment
Subjects who are taking warfarin or other anticoagulants
Experimental agents must have been discontinued at least 8 weeks prior to screening for a period equivalent to 5 half-lives of the agent (whichever is longer)
Subjects suffering from known disorders of clotting and blood coagulation
Subjects who have significant abnormalities on their screening blood tests
Subjects with gastrointestinal malabsorptive disease
Subjects with uncontrolled hypercholesterolaemia
Subjects who are deemed mentally incompetent, or have a history of anorexia nervosa or bulimia
Subjects who will be unavailable for the duration of the trial, deemed unable to comply with the requirements of the study protocol, likely to be noncompliant with the protocol, or who are felt to be unsuitable by the Investigator for any other reason
Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless surgically sterile must use effective contraception (either combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation [oral, intravaginal, transdermal], progestogen only hormonal contraception associated with inhibition of ovulation [oral, injectable, implantable], intrauterine device [IUD], intrauterine hormone-releasing system [IUS], vasectomised partner, sexual abstinence (only considered an acceptable method of contraception when it is in line with the subjects' usual and preferred lifestyle), combination of male condom with either cap, diaphragm or sponge with spermicide [double barrier methods]), and willing and able to continue contraception for 1 month after the last administration of IMP. Women using oral contraception must have started using it at least 2 months prior to screening. Women are not considered to be of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels that have been confirmed to be in the "postmenopausal range". Or have had a surgical bilateral oophorectomy (with or without hysterectomy) or bilateral tubal ligation at least six weeks before the screening visit. In case of oophorectomy alone, the reproductive status of the woman should have been confirmed by follow up hormone level assessment
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