The role of sonoporation-enhanced treatment in patients with inoperable pancreatic cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Helse Bergen HF

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

27 Sep 2024 → ongoing

Decision date (initial)

2024-09-26

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

National Institues of Health

External identifiers

EU CT number

2024-512176-35-00

EudraCT number

2019-003735-28

ClinicalTrials.gov

NCT04821284

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To evaluate the safety and efficacy of the combined Gemcitabine/ Nab-Paclitaxel or FOLFIRINOX, and Sonazoid under ultrasound treatment, compared to Gemcitabine/ Nab-Paclitaxel or FOLFIRINOX treatment alone.

Secondary objectives 5

1. To further evaluate efficacy of the combined Gemcitabine/ Nab-Paclitaxel or FOLFIRINOX, and Sonazoid under ultrasound treatment, compared to Gemcitabine/ Nab-Paclitaxel or FOLFIRINOX treatment alone.
2. To evaluate the effect of sonoporation on local disease progression using CT and ultrasound.
3. To evaluate the effect of sonoporation on tumour volume using clinical diagnostic CT protocols.
4. To evaluate if sonoporation impacts surgical operability, by comparing the frequencies of patients who become surgically operable during the course of treatment.
5. To evaluate the safety of the combined Gemcitabine/ Nab-Paclitaxel or FOLFIRINOX, and Sonazoid under ultrasound treatment, compared to Gemcitabine/ Nab-Paclitaxel or FOLFIRINOX treatment alone.

Conditions and MedDRA coding

Pancreatic cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. A new diagnosis of metastatic or locally advanced pancreatic ductal adenocarcinoma
2. Must be ambulatory with an ECOG performance status between 0 and 2
3. 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
4. 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.
5. 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.
6. Patient must be ≥18 years old.

Exclusion criteria 14

1. Operable pancreatic cancer
2. 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).
3. Patient has severe chronic obstructive pulmonary disease,or pulmonary hypertension or unstable cardiopulmonary conditions.
4. Patients who are medically unstable
5. Patient with a history of any psychiatric disorder or cognitive impairment that would interfere with participation in the study.
6. Patient has a known history of HIV infection or active Hepatitis B or Hepatitis C infection.
7. Patient requires dialysis or has severely impaired renal function, defined as estimated Glomerular Filtration Rate (eGFR) < 30 at the Screening Visit.
8. 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
9. 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).
10. Patients that are allergic to any other component of Sonazoid.
11. 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).
12. Patient has any known contraindications to any of the IMPs that the patient is scheduled for. Contraindications are described in the SmPCs.
13. Any reason why, in the opinion of the investigator, the patient should not participate.
14. Patient is pregnant or is breast-feeding.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression free survival based on the RECIST-criteria

Secondary endpoints 6

1. Key secondary efficacy endpoint: Overall survival.
2. 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.
3. Number of completed chemotherapy cycles before treatment failure
4. Changes in local disease progression using RECIST-criteria (CT)
5. Changes in maximum tumour diameter (CT and ultrasound)
6. Changes in disease progression using primary tumour volume (CT and ultrasound)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 7

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Helse Bergen HF

Sponsor organisation

Helse Bergen HF

Address

Haukelandsveien 22

City

Bergen

Postcode

5021

Country

Norway

Scientific contact point

Organisation

Helse Bergen HF

Contact name

Odd Helge Gilja

Public contact point

Organisation

Helse Bergen HF

Contact name

Odd Helge Gilja

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications