Overview
Sponsor-declared trial summary
Irresectable peritoneal metastases of colorectal cancer
The main objective is to explore the anti-tumor activity (defined as overall survival) of the addition of intraperitoneal irinotecan (75 mg) to mFOLFOX4 / Bevacizumab in patients with unresectable colorectal peritoneal metastases.
Key facts
- Sponsor
- Catharina Ziekenhuis Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
- Decision date (initial)
- 2024-09-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517152-34-00
- EudraCT number
- 2022-002134-14
- ClinicalTrials.gov
- NCT06003998
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Therapy
The main objective is to explore the anti-tumor activity (defined as overall survival) of the addition of intraperitoneal irinotecan (75 mg) to mFOLFOX4 / Bevacizumab in patients with unresectable colorectal peritoneal metastases.
Conditions and MedDRA coding
Irresectable peritoneal metastases of colorectal cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Histologically confirmed colorectal cancer; - Radiologically and clinically or pathologically confirmed unresectable colorectal peritoneal metastases (e.g. PCI >20, extensive small bowel involvement, unresectable disease due to anatomical location); - WHO performance score of 0-1 with a life expectancy of >3 months; - Aged 18 years or older; - Written informed consent.
Exclusion criteria 1
- Presence of extensive systemic metastases that are deemed to be the dominant factor determining prognosis in terms of life expectancy and performance status [e.g. no imminent threat of impaired organ functioning due to the presence of systemic metastases]); - Prior cytoreductive surgery; - Prior palliative systemic therapy for colorectal cancer; - Prior neo-adjuvant/adjuvant systemic therapy for colorectal cancer within the last 6 months; - Homozygous UGT1A1*28 genotype; - Homozygous dihydropyrimidine dehydrogenase (DPD) deficiency - Microsatellite instable (MSI) primary tumor - Inadequate organ functions, defined as an haemoglobin of <5 mmol/L, an absolute neutrophil count of <1.5 x 109/L, platelet count of <100 x 109/L, serum creatinine of >1.5 x ULN, creatinine clearance of <30 ml/min, Bilirubin > 2x ULN and liver transaminases of >5 x ULN.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To determine the anti-tumor activity in patients treated with intraperitoneal irinotecan (75 mg) and concomitant palliative systemic therapy, in terms of overall survival (calculated from (a) the interval from diagnosis of peritoneal metastases until death or last follow-up; (b) the interval from the first day of the first cycle until death or last follow-up).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Irinotecan Hydrochloride 20 mg/ml concentrate for solution for infusion
PRD10908416 · Product
- Active substance
- Irinotecan Hydrochloride Trihydrate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAPERITONEAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 900 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01CE02 — -
- Marketing authorisation
- PL 56284/0010
- MA holder
- EUGIA (UK) LTD
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Intraperitoneal use instead of intravenous use. Furthermore, the Medicinal Product is being dissolved in 1 Litre of NaCl 0.9% and prewarmed to 37◦C.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Catharina Ziekenhuis Stichting
- Sponsor organisation
- Catharina Ziekenhuis Stichting
- Address
- Michelangelolaan 2
- City
- Eindhoven
- Postcode
- 5623 EJ
- Country
- Netherlands
Scientific contact point
- Organisation
- Catharina Ziekenhuis Stichting
- Contact name
- Jacobus (Pim) Burger
Public contact point
- Organisation
- Catharina Ziekenhuis Stichting
- Contact name
- Jacobus (Pim) Burger
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 85 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-517152-34 | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment procedure NL_2024-517152-34 | 1 |
| Subject information and informed consent form (for publication) | L1_PIF_IC_2024-517152-34 | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Irinotecan_2024-517152-34 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-517152-34 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-08 | Netherlands | Acceptable with conditions 2024-09-03
|
2024-09-03 |