Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
134
Countries
1
Sites
13
METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA
Progression-free-survival rate (PFSR) at day 85
Key facts
- Sponsor
- Groupe Belge D'Oncologie Digestive
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 21 Feb 2022 → ongoing
- Decision date (initial)
- 2024-09-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Servier Affaires Médicales · Servier Benelux S.A.
External identifiers
- EU CT number
- 2024-516336-97-00
- EudraCT number
- 2020-003889-39
- ClinicalTrials.gov
- NCT05472259
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Progression-free-survival rate (PFSR) at day 85
Secondary objectives 4
- Safety/toxicity and tolerability profile: according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5
- Progression free survival (PFS) and sensitivity analyses
- Overall response and duration of response as assessed by imaging (RECIST 1.1) and tumor markers
- Overall survival (OS)
Conditions and MedDRA coding
METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 11
- Histologically proven metastatic adenocarcinoma of the pancreas
- Progression documented after first line treatment with Gemcitabine-Abraxane or gemcitabine alone
- Signed written informed consent
- Age ≥ 18
- ECOG PS 0/1 at study entry
- Measurable disease
- Adequate renal (serum creatinine ≤ 1.5x upper reference range), liver (total bilirubin ≤ 1.5x upper reference range) and hematopoietic functions (PMN ≥ 1,5x109/L, platelets ≥ 100x109/L, hemoglobin ≥ 9g/dl)
- INR/PTT ≤ 1.5x ULN
- Life expectancy of at least 12 weeks
- Effective contraception for both male and female patients if the risk of conception exists
- Peripheral Neuropathy < grade 2
Exclusion criteria 19
- Uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension
- History of myocardial infarction, deep venous or arterial thrombosis, CVA during the last 6 months
- Known hypersensitivity to any of the components of study treatments
- Previous malignancy in the last past 3 years except basal cell cancer of the skin, pre-invasive cancer of the cervix or carcinoma in situ of any type
- Pregnancy or breast feeding
- Medical or psychological conditions that would not permit the patient to complete the study or sign inform consent
- Unstable angina, congestive heart failure ≥NYHA class II
- Uncontrolled hypertension despite optimal management (systolic blood pressure >150 mmHg or diastolic pressure > 90mmHg
- HIV infection
- Complete DPD deficiency
- Liver failure, cirrhosis Child Pugh B or C
- Active chronic hepatitis B or C with a need for antiviral treatment
- Brain metastasis
- Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to the first dose of treatment
- History of organ allograft
- Ongoing uncontrolled, serious infection
- Renal failure requiring dialysis
- Patients receiving or having received any investigational treatment within 4 weeks prior to the first dose of treatment, or participating to another clinical study
- The following drugs are noted as interacting with Pegylated liposomal irinotecan (in combination with 5-FU and LV, in patients who have progressed following gemcitabine-based therapy), and are therefore excluded from the study: Live or live-attenuated vaccines in patients immunocompromised by chemotherapy, strong CYP3A4 inducers such as anticonvulsants (phenytoin, phenobarbital or carbamazepine), rifampin, rifabutin and St. John’s wort. Strong CYP3A4 inhibitors (e.g. grapefruit juice, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole and ketoconazole). Strong CYP3A4 inhibitors should be discontinued at least 1 week prior to starting ONIVYDE pegylated liposomal therapy. Strong UGT1A1 inhibitors (e.g. atazanavir, gemfibrozil, indinavir, regorafenib)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFSR is defined as the proportion of patients alive and free of progression at day 85. Patients who do not progress are considered achieving either a stable disease (SD), a partial response (PR) or a complete response (CR) at day 85, according to RECIST 1.1 criteria. Patients who are unable to be evaluated at day 85, due to rapid clinical deterioration or death from any cause or start of an additional anti-tumor therapy, will be considered as progressive disease (PD).
Secondary endpoints 7
- Safety/toxicity and tolerability profile: Adverse events, laboratory safety assessment, physical examination
- PFS and sensitivity analysis
- Objective tumor response according to RECIST v 1.1
- Overall survival
- Disease control
- Duration of response
- Exploratory endpoint: Translational analysis on tumor tissue and blood samples
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 14
Onivyde pegylated liposomal 4.3 mg/ml concentrate for dispersion for infusion
PRD6811022 · Product
- Active substance
- Irinotecan
- Pharmaceutical form
- CONCENTRATE FOR DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 70 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1260 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XX19 — IRINOTECAN
- Marketing authorisation
- EU/1/16/1130/001
- MA holder
- LES LABORATOIRES SERVIER (SURESNES)
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fluorouracil Accord Healthcare 50 mg/ml oplossing voor injectie of infusie
PRD415453 · Product
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1200 mg/m2 milligram(s)/square meter
- Max total dose
- 43200 mg/m3 milligram(s)/cubic meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- BE345597
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fluorouracil Accord Healthcare 50 mg/ml oplossing voor injectie of infusie
PRD415452 · Product
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1200 mg/m2 milligram(s)/square meter
- Max total dose
- 43200 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- BE345624
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fluorouracil Accord Healthcare 50 mg/ml oplossing voor injectie of infusie
PRD415451 · Product
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1200 mg/m2 milligram(s)/square meter
- Max total dose
- 43200 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- BE345606
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fluorouracil Accord Healthcare 50 mg/ml oplossing voor injectie of infusie
PRD415449 · Product
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1200 mg/m3 milligram(s)/cubic meter
- Max total dose
- 43200 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- BE345615
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fluorouracil Accord Healthcare 50 mg/ml oplossing voor injectie of infusie
PRD415450 · Product
- Active substance
- Fluorouracil
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1200 mg/m2 milligram(s)/square meter
- Max total dose
- 43200 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC02 — FLUOROURACIL
- Marketing authorisation
- BE415712
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Oxaliplatin Accord Healthcare 5 mg/ml concentraat voor oplossing voor infusie
PRD386321 · Product
- Active substance
- Oxaliplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 60 mg/m2 milligram(s)/square meter
- Max total dose
- 1080 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA03 — OXALIPLATIN
- Marketing authorisation
- BE418555
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Oxaliplatin Accord Healthcare 5 mg/ml concentraat voor oplossing voor infusie
PRD386319 · Product
- Active substance
- Oxaliplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 60 mg/m2 milligram(s)/square meter
- Max total dose
- 1080 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA03 — OXALIPLATIN
- Marketing authorisation
- BE373992
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Oxaliplatin Accord Healthcare 5 mg/ml concentraat voor oplossing voor infusie
PRD386320 · Product
- Active substance
- Oxaliplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 60 mg/m2 milligram(s)/square meter
- Max total dose
- 1080 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA03 — OXALIPLATIN
- Marketing authorisation
- BE374001
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ELVORINE 50 mg/5 mL, solution injectable
PRD495689 · Product
- Active substance
- Levoleucovorin
- Substance synonyms
- Levofolinic acid, L-Folinic acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 400 mg/m2 milligram(s)/square meter
- Max total dose
- 7200 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- V03AF04 — CALCIUM LEVOFOLINATE
- Marketing authorisation
- 34009 348 989 8 3
- MA holder
- PFIZER HOLDING FRANCE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ELVORINE 25 mg/2,5 mL, solution injectable
PRD422923 · Product
- Active substance
- Levoleucovorin
- Substance synonyms
- Levofolinic acid, L-Folinic acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 400 mg/m2 milligram(s)/square meter
- Max total dose
- 7200 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- V03AF04 — CALCIUM LEVOFOLINATE
- Marketing authorisation
- 34009 348 988 1 5
- MA holder
- PFIZER HOLDING FRANCE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Levofolic 50 mg/ml oplossing voor injectie / infusie
PRD557823 · Product
- Active substance
- Levoleucovorin Disodium
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 200 mg/m2 milligram(s)/square meter
- Max total dose
- 3600 mg/m3 milligram(s)/cubic meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- V03AF — DETOXIFYING AGENTS FOR ANTINEOPLASTIC TREATMENT
- Marketing authorisation
- BE314596
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Levofolic 50 mg/ml oplossing voor injectie / infusie
PRD557831 · Product
- Active substance
- Levoleucovorin Disodium
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 200 mg/m2 milligram(s)/square meter
- Max total dose
- 3600 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- V03AF — DETOXIFYING AGENTS FOR ANTINEOPLASTIC TREATMENT
- Marketing authorisation
- BE314605
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Levofolic 50 mg/ml oplossing voor injectie / infusie
PRD557820 · Product
- Active substance
- Levoleucovorin Disodium
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 200 mg/m2 milligram(s)/square meter
- Max total dose
- 3600 mg/m2 milligram(s)/square meter
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- V03AF — DETOXIFYING AGENTS FOR ANTINEOPLASTIC TREATMENT
- Marketing authorisation
- BE314614
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Groupe Belge D'Oncologie Digestive
- Sponsor organisation
- Groupe Belge D'Oncologie Digestive
- Address
- Leuvensesteenweg 643
- City
- Zaventem
- Postcode
- 1930
- Country
- Belgium
Scientific contact point
- Organisation
- Groupe Belge D'Oncologie Digestive
- Contact name
- Prof. Dr. Ivan Borbath
Public contact point
- Organisation
- Groupe Belge D'Oncologie Digestive
- Contact name
- Ine De Bruyne
Locations
1 EU/EEA country · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 134 | 13 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Regional Sambre et Meuse
Gastro-entérologie, Avenue Albert 1er 185, 5000, Namur
Az Maria Middelares Gent
Digestief centrum, Buitenring-Sint-Denijs 30, 9000, Gent
Hopital Erasme
Gastro-entérologie, Lennikse Baan 808, 1070, Anderlecht
CHU Helora
Oncologie médicale, Boulevard President Kennedy 2, 7000, Mons
CHU Helora
Gastro-oncology, Rue Ferrer 159 Boite 1, 7100, La Louviere
Antwerp University Hospital
Oncology, Drie Eikenstraat 655, 2650, Edegem
Az Sint-Lucas
Gastro-oncology, Sint-Lucaslaan 29, 8310, Brugge
CHC MontLegia
Gastro-oncology, Boulev. De Patience Et Beajonc 2, 4000, Liege
Universitair Ziekenhuis Gent
Gastro-oncology, Corneel Heymanslaan 10, 9000, Gent
Grand Hopital De Charleroi
Oncologie-hematologie, Grand'rue 3, 6000, Charleroi
AZ Turnhout
Gastro-oncology, Steenweg Op Merksplas 44, 2300, Turnhout
Imelda
Gastro-oncology, Imeldalaan 9, 2820, Bonheiden
Cliniques Universitaires Saint-Luc
Gastro-entérologie, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
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 |
|---|---|---|---|---|---|
| Belgium | 2022-02-21 | 2022-05-24 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 25 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D Protocol | 2.1 |
| Recruitment arrangements (for publication) | K Advertising material | 1 |
| Recruitment arrangements (for publication) | K informedconsent_patientrecruitmentprocedure_en | 1 |
| Subject information and informed consent form (for publication) | L ENG ICF Biological study | 2.1 |
| Subject information and informed consent form (for publication) | L ENG ICF Main study | 2.1 |
| Subject information and informed consent form (for publication) | L FR ICF Biological study | 2.1 |
| Subject information and informed consent form (for publication) | L FR ICF Main study | 2.1 |
| Subject information and informed consent form (for publication) | L ICF-procedure | 1 |
| Subject information and informed consent form (for publication) | L NL ICF Biological study | 2.1 |
| Subject information and informed consent form (for publication) | L NL ICF Main study | 2.1 |
| Subject information and informed consent form (for publication) | L Sponsor Statement ICF template | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Folinic acid Levofolic FR SMPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Folinic acid Levofolic NL SMPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G fluorouracyl FR SMPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G fluorouracyl NL SMPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G Folinic acid Elvorine FR SMPC | 2016 |
| Summary of Product Characteristics (SmPC) (for publication) | G Folinic acid Elvorine NL SMPC | 2016 |
| Summary of Product Characteristics (SmPC) (for publication) | G Oxaliplatine Accord FR SMPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G Oxaliplatine Accord NL SMPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G Oxaliplatine Fresenius FR SMPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G Oxaliplatine Fresenius NL SMPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G Oxaliplatine Teva FR SMPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G Oxaliplatine Teva NL SMPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Onivyde FR SMPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SKP Onivyde 5mg-ml | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-26 | Belgium | Acceptable with conditions 2024-09-11
|
2024-09-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-14 | Belgium | Acceptable with conditions | 2025-02-25 |