PERFLUBUTANE for Pancreatic ductal adenocarcinoma | Locally advanced pancreatic cancer | Metastatic pancreatic cancer

Inclusion criteria

• {"criterion_text":"- A new diagnosis of metastatic or locally advanced pancreatic ductal adenocarcinoma\n- Must be ambulatory with an ECOG performance status between 0 and 2\n- Female patients of child-bearing potential must have a negative urine pregnancy test and use (and agree to continue to use) an effective or highly effective birth control method\n- Male patients with a female partner who is considered of childbearing potential, must agree to use a condom throughout the study and for 6 months after last exposure to the IMPs.\n- Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH/GCP, and national/local regulations.\n- Patient must be ≥18 years old."}

Exclusion criteria

• {"criterion_text":"- Operable pancreatic cancer\n- Patients that are allergic to any other component of Sonazoid.\n- Patient is allergic to or intolerant of any IMPs included in the chemotherapy regimen that the patient is scheduled for (Gemcitabine/Nab-Paclitaxel or FOLFIRINOX).\n- Patient has any known contraindications to any of the IMPs that the patient is scheduled for. Contraindications are described in the SmPCs.\n- Any reason why, in the opinion of the investigator, the patient should not participate.\n- Patient is pregnant or is breast-feeding.\n- Patient participated in an investigational study within 7 days prior to study entry (or, if longer, within five half-lives of the last dose of any investigational drug).\n- Patient has severe chronic obstructive pulmonary disease,or pulmonary hypertension or unstable cardiopulmonary conditions.\n- Patients who are medically unstable\n- Patient with a history of any psychiatric disorder or cognitive impairment that would interfere with participation in the study.\n- Patient has a known history of HIV infection or active Hepatitis B or Hepatitis C infection.\n- Patient requires dialysis or has severely impaired renal function, defined as estimated Glomerular Filtration Rate (eGFR) < 30 at the Screening Visit.\n- Patient has severe impairment of liver function, defined as a serum albumin level ≤ 25 g/L and/or a Protrombin Time INR > 2.3 (or APTT > 6 seconds above the ULN) or Child Pugh Score C, at the Screening Visit\n- Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock. (Subjects with nonanaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 h following the administration of Sonazoid)."}

Primary endpoints

• {"endpoint_text":"- Progression free survival based on the RECIST-criteria","definition_or_measurement_approach":"Assessed using RECIST criteria (radiological assessment)."}

Secondary endpoints

• {"endpoint_text":"- Key secondary efficacy endpoint: Overall survival.","definition_or_measurement_approach":"Overall survival measured as time from randomisation/enrolment to death from any cause (not explicitly detailed in document)."}
• {"endpoint_text":"- Time to treatment failure, defined as time from study day 1 to disease progression (RECIST-criteria from CT) and/or rapidly deteriorating ECOG performance status.","definition_or_measurement_approach":"Defined in text: time from study day 1 to disease progression (RECIST by CT) and/or rapidly deteriorating ECOG performance status."}
• {"endpoint_text":"- Number of completed chemotherapy cycles before treatment failure","definition_or_measurement_approach":"Count of completed chemotherapy cycles prior to treatment failure."}
• {"endpoint_text":"- Changes in local disease progression using RECIST-criteria (CT)","definition_or_measurement_approach":"Assessed by CT using RECIST criteria."}
• {"endpoint_text":"- Changes in maximum tumour diameter (CT and ultrasound)","definition_or_measurement_approach":"Measured by CT and ultrasound (change in maximum tumour diameter)."}
• {"endpoint_text":"- Changes in disease progression using primary tumour volume (CT and ultrasound)","definition_or_measurement_approach":"Measured by CT and ultrasound (primary tumour volume changes)."}

Norway

Earliest CTIS Part Ii Submission Date

09-09-2024

Latest Decision Or Authorization Date

26-09-2024

Processing Time Days

17

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Helse Bergen HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway