Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruitment pending
Participants planned
36
Countries
1
Sites
1
Atherosclerosis
To evaluate the effect of colchicine on coronary vessel wall inflammation
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2025-03-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- ZonMW
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To evaluate the effect of colchicine on coronary vessel wall inflammation
Secondary objectives 6
- To evaluate the effect of colchicine on major cardiovascular adverse events
- To evaluate the effect of colchicine on vessel wall inflammation, vessel wall calcification, and lymphoid organs
- To evaluate the effect of colchicine on plasma markers of inflammation
- To evaluate the effect of colchicine on the composition of the blood immune profile
- To evaluate the effect of colchicine on immune-related adverse events
- To evaluate the effect of the gut microbiome composition on the effect of colchicine
Conditions and MedDRA coding
Atherosclerosis
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Open-label randomized controlled trial Patients with cancer who are planned for >3 months of treatment with a PD-1 or PD-L1 inhibitor will be randomized to 12 weeks of colchicine 0.5 mg once daily or usual care.
|
Randomised Controlled | None | Colchicine: Colchicine 0.5 mg once daily Usual care: Standard of care |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Age 50 years or older
- Planned for treatment with a PD-1 or PD-L1 inhibitor for at least 3 months
- Signs of atherosclerosis on imaging (e.g. coronary artery calcium score >0 on cancer staging chest CT-scan or calcifications of aorta, abdominal arteries, or iliac arteries abdomino/pelvic CT-scan)
Exclusion criteria 9
- Chest radiation therapy in prior 3 months (or planned during the study)
- Moderate or severe renal impairment (eGFR <50 mL/min/1.73 m2 based on CKD-EPI)
- Child Pugh B or C liver cirrhosis
- Known intolerance to colchicine
- Use of immunosuppressive medication at randomization
- Use of strong CYP3A4 inhibitors
- Colchicine use in previous <3 months
- Indication for long-term treatment with colchicine
- Inability to provide written informed consent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change in maximum target-to-background ratio (TBRmax) in coronary arteries, which quantifies 68Gallium-DOTATATE uptake, between baseline and 12-week follow-up on PET-scan.
Secondary endpoints 9
- TBRmax in carotid arteries
- TBRmax in aorta
- Mean standardized uptake value (SUVmean) in spleen
- SUVmean in bone marrow
- Coronary artery calcium score
- Major adverse cardiovascular events (i.e. myocardial infarction, ischemic stroke, ischemia-driven coronary revascularisation, death)
- All-cause mortality
- Immune related adverse events
- Biomarkers (e.g. blood inflammatory markers, PBMCs, plasma cytokines, metabolomics, and microbiome composition)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP129899 · ATC
- Active substance
- Colchicine
- Route of administration
- ORAL
- Max daily dose
- 3 mg milligram(s)
- Max total dose
- 9999999 mg milligram(s)
- Max treatment duration
- 999 Month(s)
- Authorisation status
- Authorised
- ATC code
- M04AC01 — COLCHICINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
-
V09IX · Product
- Pharmaceutical form
- PHF00231MIG
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2500 MBq megabecquerel(s)
- Max total dose
- 5000 MBq megabecquerel(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- V09IX — OTHER DIAGNOSTIC RADIOPHARMACEUTICALS FOR TUMOUR DETECTION
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- Meibergdreef 9
- City
- Amsterdam
- Postcode
- 1105 AZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Principal investigator
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Principal investigator
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 36 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Amsterdam UMC Stichting
Vascular Medicine, De Boelelaan 1117, 1081 HV, Amsterdam
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-518100-45-00 COLA trial version 1_0 - 25 October 2024 | 1.1 |
| Protocol (for publication) | D1_Protocol 2024-518100-45-00 COLA trial version 1_0 - 25 October 2024-signed | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 2.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC colchicine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Package insert (bijsluiter) colchicine | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL 2024-518100-45-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-28 | Netherlands | Acceptable 2025-03-25
|
2025-03-31 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-04-08 | Netherlands | Acceptable 2025-03-25
|
2025-04-08 |