Optimizing Ultrasound Enhanced Delivery of Therapeutics

Phase 1

• Conditions: Histologically verified, locally advanced (nonresectable Stage II/III) or metastatic (Stage IV) adenocarcinoma of the pancreas.; MedDRA version: 21.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticSystem Organ Class: 100000004864; MedDRA version: 21.0Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003735-28-NO
• Lead Sponsor: Helse Bergen HF, Department of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-22
• Last Update Posted: 8 March 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients, who meet all the following inclusion criteria, are eligible for the study entry:
•Patient must be =18 years old.
•Patient has a diagnosis of inoperable PDAC and are scheduled to undergo SoC chemotherapy
o(ICD-10 C25.0 Malignant neoplasm: Body of pancreas, C25.2 Malignant neoplasm: Tail of pancreas and C25.3 Malignant neoplasm: Pancreatic duct).
oHistologically verified, locally advanced (nonresectable Stage II/III) or metastatic (Stage IV) adenocarcinoma of the pancreas.
•The PDAC must be visible on ultrasound.
•Must be ambulatory with an ECOG performance status between 0 and 2.
•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. Contraception must be used from the Screening Visit, throughout the study period and for 6 months after the last exposure to the IMPs.
Effective birth control methods include:
oProgestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
oMale or female condom with or without spermicide
oCap, diaphragm or sponge with spermicide
Highly effective birth control methods include:
oCombined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)
oProgestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
oIntrauterine device (IUD)
oIntrauterine hormone-releasing system (IUS)
oBilateral tubal occlusion
oVasectomised partner
oSexual abstinence
A pregnancy test must be performed at inclusion, at end of study and at any timepoint if pregnancy is suspected during the study period.

[Definition: A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.]
•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.
•Must have lab values as the following: Hemoglobin >10 g/dL, neutrophils (polymorphonuclear leukocytes) >3.5 109/L, PLT >150 and Bilirubin <75 µmol/L.
•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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria:
•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).
•Patient has severe chronic obstructive pulmonary disease,or pulmonary hypertension or unstable cardiopulmonary conditions.
•Patients who are medically unstable. For example:
oPatients on life support or in a critical care unit.
oPatients with unstable occlusive disease (e.g., crescendo angina)
oPatients with clinically unstable cardiac arrhythmias, such as recurrent ventricular tachycardia.
oPatients with uncontrolled congestive heart failure (NYHA Class IV)
oPatients with recent cerebral hemorrhage.
oPatients who have undergone surgery within 24 hours prior to the study sonographic examination.
•Patient with a history of any psychiatric disorder or cognitive impairment that would interfere with participation in the study.
•Patient has a known history of HIV infection or active Hepatitis B or Hepatitis C infection.
•Patient requires dialysis or has severely impaired renal function, defined as estimated Glomerular Filtration Rate (eGFR) >30 at the Screening Visit.
•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 upper limit of normal) at the Screening Visit.
•Patients with baseline ANC of < 1.5 x 109/L or platelets < 100 x 109/L prior to each treatment cycle.
•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).
•Patients that are allergic to any other component of Sonazoid.
•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).
•Patient has any known contraindications to any of the IMPs that the patient is scheduled for. Contraindications are described in the SmPCs.
•Any reason why, in the opinion of the investigator, the patient should not participate.
•Patients with metastatic adenocarcinoma of the pancreas who have moderate to severe hepatic impairment
•Patient is pregnant or is breast-feeding.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified