IRINOTECAN for Pancreatic ductal adenocarcinoma (metastatic)

Inclusion criteria

• {"criterion_text":"- Histologically proven metastatic adenocarcinoma of the pancreas"}
• {"criterion_text":"- Effective contraception for both male and female patients if the risk of conception exists"}
• {"criterion_text":"- Peripheral Neuropathy < grade 2"}
• {"criterion_text":"- Progression documented after first line treatment with Gemcitabine-Abraxane or gemcitabine alone"}
• {"criterion_text":"- Signed written informed consent"}
• {"criterion_text":"- Age ≥ 18"}
• {"criterion_text":"- ECOG PS 0/1 at study entry"}
• {"criterion_text":"- Measurable disease"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- INR/PTT ≤ 1.5x ULN"}
• {"criterion_text":"- Life expectancy of at least 12 weeks"}

Exclusion criteria

• {"criterion_text":"- Uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension"}
• {"criterion_text":"- Complete DPD deficiency"}
• {"criterion_text":"- Liver failure, cirrhosis Child Pugh B or C"}
• {"criterion_text":"- Active chronic hepatitis B or C with a need for antiviral treatment"}
• {"criterion_text":"- Brain metastasis"}
• {"criterion_text":"- Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to the first dose of treatment"}
• {"criterion_text":"- History of organ allograft"}
• {"criterion_text":"- Ongoing uncontrolled, serious infection"}
• {"criterion_text":"- Renal failure requiring dialysis"}
• {"criterion_text":"- Patients receiving or having received any investigational treatment within 4 weeks prior to the first dose of treatment, or participating to another clinical study"}
• {"criterion_text":"- 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. \tStrong 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)"}
• {"criterion_text":"- History of myocardial infarction, deep venous or arterial thrombosis, CVA during the last 6 months"}
• {"criterion_text":"- Known hypersensitivity to any of the components of study treatments"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Pregnancy or breast feeding"}
• {"criterion_text":"- Medical or psychological conditions that would not permit the patient to complete the study or sign inform consent"}
• {"criterion_text":"- Unstable angina, congestive heart failure ≥NYHA class II"}
• {"criterion_text":"- Uncontrolled hypertension despite optimal management (systolic blood pressure >150 mmHg or diastolic pressure > 90mmHg"}
• {"criterion_text":"- HIV infection"}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"PFSR is defined as the proportion of patients alive and free of progression at day 85; assessment by RECIST 1.1 criteria. Patients unable to be evaluated at day 85 due to rapid deterioration, death, or start of additional anti-tumor therapy are considered PD."}

Secondary endpoints

• {"endpoint_text":"- Safety/toxicity and tolerability profile: Adverse events, laboratory safety assessment, physical examination","definition_or_measurement_approach":"Assessment of adverse events, laboratory safety assessments and physical examinations (per NCI CTCAE v5)."}
• {"endpoint_text":"- PFS and sensitivity analysis","definition_or_measurement_approach":"Progression-free survival assessed per RECIST and sensitivity analyses as defined in protocol."}
• {"endpoint_text":"- Objective tumor response according to RECIST v 1.1","definition_or_measurement_approach":"Objective tumor response measured using RECIST v1.1 criteria."}
• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":"Overall survival measured from randomization to death from any cause."}
• {"endpoint_text":"- Disease control","definition_or_measurement_approach":"Disease control assessed per imaging/RECIST (as defined in protocol)."}
• {"endpoint_text":"- Duration of response","definition_or_measurement_approach":"Duration of response measured from first documented response to progression or death."}
• {"endpoint_text":"- Exploratory endpoint: Translational analysis on tumor tissue and blood samples","definition_or_measurement_approach":"Translational analyses on tumor tissue and blood samples as exploratory biomarker studies per protocol."}

Other endpoints

• {"endpoint_text":"- Exploratory endpoint: Translational analysis on tumor tissue and blood samples","definition_or_measurement_approach":"Translational analyses on tumor tissue and blood samples as exploratory biomarker studies per protocol."}

Belgium

Earliest CTIS Part Ii Submission Date

03-09-2024

Latest Decision Or Authorization Date

25-02-2025

Processing Time Days

175

Number Of Sites

13

Number Of Participants

134

Primary sponsor

Full Name

Groupe Belge D'Oncologie Digestive

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium

Third parties

• {"country":"","full_name":"Servier Affaires Médicales","duties_or_roles":"Monetary support","organisation_type":""}
• {"country":"","full_name":"Servier Benelux S.A.","duties_or_roles":"Monetary support","organisation_type":""}