Digitoxin Pancreatic cancer trial-1

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Vaestra Goetalandsregionen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

11 Nov 2025 → ongoing

Decision date (initial)

2024-12-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

The primary objective of this trial is to improve the survival of patients with inoperable pancreatic adenocarcinoma.

Secondary objectives 4

1. to evaluate the effectiveness of chemotherapy and digitoxin in intention-to-treat (ITT) and per protocol (PP) treated population.
2. Safety and tolerability of the treatment regimens.
3. Life quality assessments
4. Translational studies; Cytokines will be analysed at baseline and at 3 months.

Conditions and MedDRA coding

Pancreatic cancer

Regulatory references

Plan to share IPD

No

IPD plan description

Contact Scientific Contact Point for discussion about IPD.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Male or female, 18 years or older.
2. WHO performance status 0-2.
3. Histologically or cytologically confirmed inoperable adenocarcinoma of the pancreas. Histologically or cytologically confirmed from primary tumor in the pancreas or metastasis.
4. The patient shall be newly diagnosed and not have started any other treatment for the pancreatic cancer.
5. Radiographically measurable or evaluable disease, according RECIST (v1.1).
6. The patient is able to take care of his/her medication.
7. The patient has given written consent to participate in the trial.
8. Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
9. Female patients of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 6 months after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
10. Male patients with a female partner of childbearing potential must agree to use an adequate method of contraception (condom and acceptable contraception method for the partner), starting with the first dose of study therapy through 6 months after the last dose of study therapy. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

Exclusion criteria 24

1. Chronic or current active infectious disease requiring systemic antibiotics, antifungal or antiviral treatment.
2. Significant concurrent, uncontrolled medical condition including, but not limited: to renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
3. Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from day 1 of trial drug administration. Patients with heart disease already on a cardiac glycoside are not eligible.
4. Cardiac arrythmia which may worsen by digitoxin therapy.
5. Current or previous other malignancy within 2 years of trial entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other non-invasive or indolent malignancy.
6. Patient who has already been subjected to or started chemotherapy or other treatment for the pancreatic cancer.
7. Absolute B-neutrophil count (ANC) <1.5 × 10^9/L.
8. B-Platelets < 75 × 10^9/L.
9. B-Haemoglobin < 9 g/L (transfusions are permitted to achieve baseline haemoglobin level).
10. P-ALAT/ASAT > 2.5 × ULN; or > 5 × ULN in the presence of liver metastases.
11. Total P-bilirubin > 1.5 × ULN (use of biliary stent to achieve bilirubin levels is permitted).
12. S- LDH > 3 × ULN in the absence of haemolysis.
13. P-Potassium < 3.5 or > 4.5 mmol/L.
14. P-Sodium <137 or >145 mmol/L
15. P-Albumin <25 g/L
16. P-Calcium < 2.15 or > 2.50 mmol/L.
17. S-Magnesium <0.7 mmol/L or > 1.1 mmol/L
18. S-creatinine > 150 μmol/L.
19. Pregnancy or female patients that are breastfeeding and not willing to refrain.
20. Hypersensitivity to digitoxin or other cardiac glycoside or any other ingredients in the tablets (see SmPC).
21. Carotid sinus syndrome.
22. Simultaneous administration of intravenous calcium salts.
23. Thoracic aortic aneurysm.
24. Intended electrical cardioversion.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression free survival at 1 year; from the date of enrollment, i.e. from start to take digitoxin tablets.

Secondary endpoints 7

1. Overall survival at 1 year.
2. Progression-free survival defined as the time from enrollment until the earliest date of disease progression determined by assessment of objective radiographic disease per RECIST (v1.1).
3. Objective response rate and duration of response determined by radiographic disease assessments per RECIST (v1.1).
4. Safety and tolerability of the treatment regimens by assessment of adverse events and changes in safety assessments including laboratory parameters.
5. Biochemical response: change in serum tumor markers (CA19-9, CEA, CA125) before start of digitoxin tablets as baseline and at every 3 months evaluation.
6. Quality of Life according to EORTC QLQ-C30 and EORTC QLQ-PAN-26.
7. Translational studies: Cytokines pivotal for cancer and inflammation will be analyzed. More than 40 cytokines will be examined before start of digitoxin and at 3 months of treatment with digitoxin.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vaestra Goetalandsregionen

Sponsor organisation

Vaestra Goetalandsregionen

Address

Regionens Hus

City

Vänersborg

Postcode

462 80

Country

Sweden

Scientific contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Johan Haux

Public contact point

Organisation

Vaestra Goetalandsregionen

Contact name

Johan Haux

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 5 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