Clinical trial • Phase IV • Oncology|Rare Disease
Mesalazine for Lynch syndrome
Phase IV trial of Mesalazine for Lynch syndrome.
Overview
- Trial Therapeutic Area
- Oncology|Rare Disease
- Trial Disease
- Lynch syndrome
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 12-11-2024
- First CTIS Authorization Date
- 27-11-2024
Trial design
Active: Pentasa Sachet 2 g depotgranulat (mesalazine) — product listing shows max daily dose amount 2 g; Placebo: Pentasa PLACEBO Sachet 2g in the granule formulation specifically designed to resemble the active drug product. Schedule/frequency not specified in the available data.-controlled Phase IV trial across 8 sites in Denmark, Sweden.
- Comparator
- Active: Pentasa Sachet 2 g depotgranulat (mesalazine) — product listing shows max daily dose amount 2 g; Placebo: Pentasa PLACEBO Sachet 2g in the granule formulation specifically designed to resemble the active drug product. Schedule/frequency not specified in the available data.
- Target Sample Size
- 75
- Trial Duration For Participant
- 810
Eligibility
Recruits 75 Vulnerable population selected. Signed written informed consent prior to inclusion in the study is required. Participants considered unable to give informed consent are excluded..
- Pregnancy Exclusion
- Pregnant or breastfeeding women
- Vulnerable Population
- Vulnerable population selected. Signed written informed consent prior to inclusion in the study is required. Participants considered unable to give informed consent are excluded.
Inclusion criteria
- {"criterion_text":"- 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\n- Male or female subjects with the age > 30 years\n- 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 randomization\n- Signed written informed consent prior to inclusion in the study"}
Exclusion criteria
- {"criterion_text":"- Presence of colorectal endoscopically non-removable malign neoplasia (patient can be included if the adenoma is removed)\n- Unwillingness to participate or who is considered unable to give an informed consent\n- Pregnant or breastfeeding women\n- Participation in another clinical study investigating another IMP within 3 months prior to screening\n- Renal insufficiency (GFR <30ml/min/1.73m2)\n- Severe liver disease or liver failure (elevation of liver enzymes above 3xULN)\n- 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 and efficacy or protocol adherence\n- 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), duodenal ulcer, haemorrhagic diathesis or psychiatric condition or other abnormal clinical sign 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\n- Carriers of germline mutations in PMS2\n- Patients with history of stage 3 and 4 colorectal cancer (CRC) are excluded\n- Presence of any metastatic disease\n- Regular use of acetylsalicylic acid (ASA or aspirin): daily use of ≥100mg in more than 3 continuous months within the last year\n- Regular use of NSAIDs or COX-2 inhibitors: daily use in more than 3 continuous months within the last year\n- Hypersensitivity to 5-ASA\n- Patients after any subtotal or total colectomy\n- Colorectal surgery within the previous 6 months"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Occurrence of any colorectal neoplasia (both benign and malignant tumors)","definition_or_measurement_approach":"As detected by any colonoscopy until the end of treatment (24 months + 3 months) and end of study"}
Secondary endpoints
- {"endpoint_text":"- The number of colorectal neoplasia (both benign and malignant tumors) per patient","definition_or_measurement_approach":"Not specified"}
- {"endpoint_text":"- The tumor progress in the 4 ordered stages","definition_or_measurement_approach":"Not specified"}
- {"endpoint_text":"- The dependence of treatment effects on history of colorectal cancer, sex and patients age (<45 years and ≥45 years)","definition_or_measurement_approach":"Not specified"}
- {"endpoint_text":"- Safety data are described and compared between groups in an exploratory manner","definition_or_measurement_approach":"Not specified"}
Recruitment
- Planned Sample Size
- 75
- Recruitment Window Months
- 283
- Consent Approach
- Signed written informed consent prior to inclusion in the study is required. Participants unable to give informed consent are excluded. Country-specific ICF/SIS documents are listed for Denmark and Sweden but languages and age-specific assent procedures are not specified in the available data.
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 150
Denmark
- Latest Decision Or Authorization Date
- 25-03-2025
- Number Of Sites
- 2
- Number Of Participants
- 75
Sites
- Site Name
- Hvidovre Hospital
- Department Name
- Dept of Surgical Gastroenterology, Amager Hvidovre Hospital
- Principal Investigator Name
- Lars Joachim Lindberg
- Principal Investigator Email
- lars.joachim.lindberg@regionh.dk
- Contact Person Name
- Lars Joachim Lindberg
- Contact Person Email
- lars.joachim.lindberg@regionh.dk
Sweden
- Latest Decision Or Authorization Date
- 25-03-2025
- Number Of Sites
- 6
- Number Of Participants
- 75
Sites
- Site Name
- Uppsala University Hospital
- Department Name
- Dept of Medical Sciences, Gastroenterology/Hepatology
- Principal Investigator Name
- Peter Thelin Schmidt
- Principal Investigator Email
- peter.thelin.schmidt@medsci.uu.se
- Contact Person Name
- Peter Thelin Schmidt
- Contact Person Email
- peter.thelin.schmidt@medsci.uu.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- GI-unit, 2nd floor, Jan Waldenstroems gata 14
- Principal Investigator Name
- Rita J Gustafsson
- Principal Investigator Email
- rita.j.gustafsson@skane.se
- Contact Person Name
- Rita J Gustafsson
- Contact Person Email
- rita.j.gustafsson@skane.se
- Site Name
- Region Vaesterbotten
- Department Name
- KFE, QA41, Cancercentrum
- Principal Investigator Name
- Gustav Silander
- Principal Investigator Email
- gustav.silander@regionvasterbotten.se
- Contact Person Name
- Gustav Silander
- Contact Person Email
- gustav.silander@regionvasterbotten.se
- Site Name
- Karolinska University Hospital
- Department Name
- Hereditary cancer, Dept of breastcancer, endocrine tumors and sarcoma
- Principal Investigator Name
- Irene Stenfors
- Principal Investigator Email
- irene.stenfors@regionstockholm.se
- Contact Person Name
- Irene Stenfors
- Contact Person Email
- irene.stenfors@regionstockholm.se
- Site Name
- Ersta Sjukhus-Ersta Hospital
- Department Name
- Forskningsenheten pl 6
- Principal Investigator Name
- Ann-Sofie Backman
- Principal Investigator Email
- ann-sofie.backman@ki.se
- Contact Person Name
- Ann-Sofie Backman
- Contact Person Email
- ann-sofie.backman@ki.se
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Oestra Hospital, VO Surgery
- Principal Investigator Name
- David Ljungman
- Principal Investigator Email
- david.ljungman@vgregion.se
- Contact Person Name
- David Ljungman
- Contact Person Email
- david.ljungman@vgregion.se
Sponsor
Primary sponsor
- Full Name
- Karolinska Institutet
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Sweden
Third parties
- {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code: 1; contact email: gcp-enheden.bispebjerg-frederiksberg-hospitaler@regionh.dk","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- Pentasa Sachet 2 g depotgranulat
- Active Substance
- Mesalazine
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Authorisation Status
- Authorised (SE, marketing authorisation number 25569)
- Maximum Dose
- 2 g per day
- Investigational Product Name
- Pentasa PLACEBO Sachet 2g in the granule formulation specifically designed to resemble the active drug product
- Modality
- Other
- Authorisation Status
- Not applicable
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