Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
34
Countries
1
Sites
4
ADCC
To evaluate whether the administration of FOLFIRI/Cetuximab is effective as a first-line treatment for patients with metastatic colorectal cancer, RAS wild-type and FcγRIIIA V/V.
Key facts
- Sponsor
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 12 Jun 2019 → ongoing
- Decision date (initial)
- 2024-11-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518987-11-00
- EudraCT number
- 2018-003778-29
- ClinicalTrials.gov
- NCT03874026
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Therapy
To evaluate whether the administration of FOLFIRI/Cetuximab is effective as a first-line treatment for patients with metastatic colorectal cancer, RAS wild-type and FcγRIIIA V/V.
Conditions and MedDRA coding
ADCC
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10052358 | Colorectal cancer metastatic | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- Cytological or histological diagnosis of colorectal adenocarcinoma FOLFIRI+Cetuximab in first-line treatment of metastatic colorectal cancer, RAS wild type, and Fc-γRIIIA-V/V
- RAS wild-type
- FcγRIIIa-158V/V genotype
- Stage IV
- Negative pregnancy test, where applicable
- Age < 75 years
- At least one measurable lesion according to RECIST v1.1 criteria
- ECOG Performance Status 0 or 1
- Life expectancy > 3 months
- Written informed consent
Exclusion criteria 11
- Previous systemic anti-tumor treatment; treatment with Capecitabine or fluorouracil and radiotherapy is allowed in the neoadjuvant setting for rectal cancer, provided that therapy was completed at least 6 months prior.
- Presence of untreated stenosing primary colorectal neoplasia with the placement of an endoprosthesis
- Neutrophils < 2000/mm³, or platelets < 100,000/mm³, or hemoglobin < 9 g/dl
- Creatinine > 1.5 times the upper normal limit
- GOT (AST) and/or GPT (ALT) > 5 times the upper normal limit and/or bilirubin > 3 times the upper normal limit
- Previous malignant neoplasia (excluding basal cell or squamous cell skin carcinoma or in situ carcinoma of the uterine cervix)
- Active or uncontrolled infection
- Other concomitant decompensated or uncontrolled diseases, or conditions that contraindicate the study drugs, at the clinician's discretion
- Presence of brain metastases
- Refusal or inability to provide informed consent
- Inability to ensure follow-up
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Activity assessed by RECIST criteria version 1.1
Secondary endpoints 4
- Response duration
- PFS will be determined from the date of treatment start until progression.
- OS will be measured from treatment start until death from any cause.
- Toxic effects assessed by CTCAE of the National Cancer Institute, version 4.0, June 14, 2010
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
SUB08295MIG · Substance
- Active substance
- Irinotecan
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 180 mg/m2 milligram(s)/sq. meter
- Max total dose
- 180 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1000 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07721MIG · Substance
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 2800 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2800 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1000 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13910MIG · Substance
- Active substance
- Folinic Acid
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 400 mg/m2 milligram(s)/sq. meter
- Max total dose
- 400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1000 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB01178MIG · Substance
- Active substance
- Cetuximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 650 mg/m2 milligram(s)/sq. meter
- Max total dose
- 650 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1000 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Sponsor organisation
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Address
- Via Mariano Semmola 52
- City
- Naples
- Postcode
- 80131
- Country
- Italy
Scientific contact point
- Organisation
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Contact name
- Alessandro Ottaiano
Public contact point
- Organisation
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Contact name
- Alessandro Ottaiano
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 34 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Presidio Ospedaliero Santa Maria delle Grazie
Oncologia Medica, Via domitiana, 80078, Località la Schiana, Pozzuoli (NA)
Azienda Ospedaliera Specialistica dei Colli – Ospedale Monaldi
U.O.C. Oncologia, Via Leonardo Bianchi 80131 Napoli, Italy, napoli
Ospedale Civile San Giovanni di Dio - Frattamaggiore
U.O.C. Oncologia, Via Pirozzi, 66, Frattamaggiore
IRCCS Istituto Nazionale Tumori Fondazione Pascale
SSD Terapie innovative nelle metastasi addominali, Via Mariano Semmola 52, 80131, Naples
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2019-06-12 | 2019-09-05 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocollo Studio CIFRA v1 1 del 26 Apr 2021 red | 1.1 |
| Recruitment arrangements (for publication) | blank document_PDF | 1 |
| Subject information and informed consent form (for publication) | Consenso Dati personali v1 1 del 26 Apr 2021 | 1.1 |
| Subject information and informed consent form (for publication) | Consenso informato CIFRA v1 1 del 26 Apr 2021 | 1.1 |
| Subject information and informed consent form (for publication) | Lettera al Medico Curante CIFRA v1 1 del 26 Apr 2021 | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | blank document_PDF | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | blank document_PDF | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | blank document_PDF | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | blank document_PDF | 1 |
| Synopsis of the protocol (for publication) | Sinossi Studio CIFRA v1 1 del 26 Apr 2021 red | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-05 | Italy | Acceptable 2024-11-22
|
2024-11-27 |