Clinical trial NCT03070574 (phase 2, status: terminated)
Conditions: colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: mesalamine 2400 mg (5-asa), mesalamine 1200 mg
SMILES: NC1=CC(C(O)=O)=C(O)C=C1, NC1=CC(C(O)=O)=C(O)C=C1
Reason stopped: 
    due to poor patient recruitment and insufficient financing.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Proven tumor-free (including patients in which the polyps are removed endoscopically)
             carriers of a germline pathologic mutation on one of the MMR genes including MLH1,
             MSH2 (including EpCAM) and MSH6

          -  Male or female subjects with the age > 25 years

          -  Females who have been post-menopausal more than one (1) year or females of
             childbearing potential using a highly efficient method of contraception with less than
             1% failure rate (i.e. oral hormonal contraceptives, hormone implants, hormone
             injections, sterilization, hormonal or copper intrauterine device,
             sterilized/vasectomized partner, or diaphragm in combination with a condom, spermicide
             or birth control pills) or should agree to abstain from heterosexual activity during
             treatment period. Females of childbearing potential must have a negative pregnancy
             test at screening and before randomization.

          -  Signed written informed consent prior to inclusion in the study

        Exclusion Criteria:

          -  Presence of colorectal endoscopically non-removable benign neoplasia (patient can be
             included if the adenoma is removed)

          -  Carriers of germline mutations in PMS2

          -  Patients with history of stage 3 and 4 colorectal cancer (CRC) are excluded

          -  Presence of metastatic disease

          -  Regular use of acetylsalicylic acid (ASA or aspirin): daily use of ≥100mg in more than
             3 continuous months within the last year

          -  Regular use of NSAIDs or COX-2 inhibitors: daily use in more than 3 continuous months
             within the last year

          -  Hypersensitivity to 5-ASA

          -  Patients after total or subtotal colectomy

          -  Colorectal surgery within the previous 6 months

          -  Unwillingness to participate or who is considered incompetent to give an informed
             consent

          -  Pregnant or breastfeeding women

          -  Participation in another clinical study investigating another IMP within 3 months
             prior to screening

          -  Renal insufficiency (GFR <30ml/min/1.73m2)

          -  Severe liver disease or liver failure (elevation of liver enzymes above 3xULN)

          -  Current or history of serious psychiatric disorder or alcohol/drug abuse that in the
             opinion of the investigator may impact the assessment of IMP safety andefficacy or
             protocol adherence

          -  Prior history of myocarditis or pericarditis. Other severe acute or chronic medical
             condition (such as severe chronic lung (COPD, including asthma), kidney or heart
             diseases) or psychiatric condition or laboratory abnormality that may increase the
             risk associated with study participation or ability to comply with study procedures,
             IMP administration and, in the judgment of the investigator, would make the subject
             inappropriate for entry into this study