PACLITAXEL ALBUMIN-BOUND for Metastatic pancreatic cancer

Inclusion criteria

• {"criterion_text":"- Signed, written Institutional Review Board/Ethics Committee-approved Informed Consent Form (ICF)."}
• {"criterion_text":"- No prior chemotherapy for metastatic disease (patients might have received adjuvant treatment more than 6 months before the development of metastatic disease, or neoadjuvant treatment before surgery for resectable disease)"}
• {"criterion_text":"- Patients with histologically/cytological confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma."}
• {"criterion_text":"- Measurable disease on computed tomography (CT) scan per RECIST version 1.1 criteria."}
• {"criterion_text":"- Eastern Cooperative Oncology Group Performance Status of 0-1"}
• {"criterion_text":"- Life expectancy ≥ 3 months."}
• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- A negative urine or serum pregnancy test within 7 days before Day 1 (first dose of study medication) if female subject is of childbearing potential."}
• {"criterion_text":"- Screening clinical laboratory values as follows: a. Absolute neutrophil count > 1.5 x 109 /L b. Total bilirubin ≤ 1.5 times upper limit of normal (ULN). c. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times ULN, (if liver metastases are present, then ≤ 5 times ULN is allowed). d. Serum creatinine < 1.5 x ULN or creatinine clearance >50 mL/min/1.73 m2 e. Prothrombin time/international normalized ratio within normal limits (± 15%) or within therapeutic range if subject takes warfarin. Partial thromboplastin time (PTT) within normal limits (± 15%). f. Platelet count > 100,000 x 109 /L"}
• {"criterion_text":"- No symptoms related to advanced disease, specified as: a. no pain requiring regular narcotic analgesics; b. no weight loss over 5 kg (unless related to surgery or other illness); c. no persistent nausea requiring medication; d. no obstructive bowel symptoms; e. no persistent fever related to metastatic cancer; f. no other symptom which in the opinion of the clinician was due to progressive metastatic cancer."}

Exclusion criteria

• {"criterion_text":"- Known central nervous system involvement or brain metastases."}
• {"criterion_text":"- New York Heart Association Class III or IV cardiac disease or myocardial infarction within the past 12 months"}
• {"criterion_text":"- Any other disease, active, uncontrolled bacterial, viral or fungal infection requiring systemic therapy, metabolic dysfunction, physical examination finding or clinical laboratory finding that leads to reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that may render the subject at high risk for treatment complications."}
• {"criterion_text":"- Inability to comply with study and follow-up procedures as judged by the Investigator."}
• {"criterion_text":"- Women currently pregnant or breastfeeding."}

Primary endpoints

• {"endpoint_text":"- Quality Adjusted Overall Survival","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Time to disease progression after inclusion (Restricted mean progression free survival (RM-PFS): area under the Kaplan-Meier PFS curve between inclusion and maximum follow-up of the study, estimated 12 months)","definition_or_measurement_approach":"Restricted mean progression free survival (RM-PFS): area under the Kaplan-Meier PFS curve between inclusion and maximum follow-up of the study, estimated 12 months"}
• {"endpoint_text":"- Quality adjusted Progression Free Survival (PFS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall survival (in months)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Duration of time without symptoms of disease progression or toxicities (TWiST)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Adverse events according to NCI CTC version 5.0","definition_or_measurement_approach":"Adverse events will be assessed according to NCI Common Terminology Criteria for Adverse Events (CTC) version 5.0"}
• {"endpoint_text":"- Change in CA 19.9","definition_or_measurement_approach":""}

Netherlands

Earliest CTIS Part Ii Submission Date

01-10-2024

Latest Decision Or Authorization Date

28-10-2024

Processing Time Days

27

Number Of Sites

14

Number Of Participants

184

Primary sponsor

Full Name

Amsterdam UMC

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands