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Digitoxin Pancreatic cancer trial-1
EU CTIS ID: 2024-512128-12-01
What this study is testing
The primary objective of this trial is to improve the survival of patients with inoperable pancreatic adenocarcinoma.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female, 18 years or older.
- 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.
- WHO performance status 0-2.
- Histologically or cytologically confirmed inoperable adenocarcinoma of the pancreas. Histologically or cytologically confirmed from primary tumor in the pancreas or metastasis.
- The patient shall be newly diagnosed and not have started any other treatment for the pancreatic cancer.
- Radiographically measurable or evaluable disease, according RECIST (v1.1).
You likely can't join if
- Chronic or current active infectious disease requiring systemic antibiotics, antifungal or antiviral treatment.
- P-ALAT/ASAT > 2.5 × ULN; or > 5 × ULN in the presence of liver metastases.
- Total P-bilirubin > 1.5 × ULN (use of biliary stent to achieve bilirubin levels is permitted).
- S- LDH > 3 × ULN in the absence of haemolysis.
- P-Potassium < 3.5 or > 4.5 mmol/L.
- P-Sodium <137 or >145 mmol/L
See the full eligibility criteria
Who can join
- Male or female, 18 years or older.
- 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.
- WHO performance status 0-2.
- Histologically or cytologically confirmed inoperable adenocarcinoma of the pancreas. Histologically or cytologically confirmed from primary tumor in the pancreas or metastasis.
- The patient shall be newly diagnosed and not have started any other treatment for the pancreatic cancer.
- Radiographically measurable or evaluable disease, according RECIST (v1.1).
- The patient is able to take care of his/her medication.
- The patient has given written consent to participate in the trial.
- 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.
- 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.
What rules you out
- Chronic or current active infectious disease requiring systemic antibiotics, antifungal or antiviral treatment.
- P-ALAT/ASAT > 2.5 × ULN; or > 5 × ULN in the presence of liver metastases.
- Total P-bilirubin > 1.5 × ULN (use of biliary stent to achieve bilirubin levels is permitted).
- S- LDH > 3 × ULN in the absence of haemolysis.
- P-Potassium < 3.5 or > 4.5 mmol/L.
- P-Sodium <137 or >145 mmol/L
- P-Albumin <25 g/L
- P-Calcium < 2.15 or > 2.50 mmol/L.
- S-Magnesium <0.7 mmol/L or > 1.1 mmol/L
- S-creatinine > 150 μmol/L.
- Pregnancy or female patients that are breastfeeding and not willing to refrain.
- Significant concurrent, uncontrolled medical condition including, but not limited: to renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
- Hypersensitivity to digitoxin or other cardiac glycoside or any other ingredients in the tablets (see SmPC).
- Carotid sinus syndrome.
- Simultaneous administration of intravenous calcium salts.
- Thoracic aortic aneurysm.
- Intended electrical cardioversion.
- 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.
- Cardiac arrythmia which may worsen by digitoxin therapy.
- 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.
- Patient who has already been subjected to or started chemotherapy or other treatment for the pancreatic cancer.
- Absolute B-neutrophil count (ANC) <1.5 × 10^9/L.
- B-Platelets < 75 × 10^9/L.
- B-Haemoglobin < 9 g/L (transfusions are permitted to achieve baseline haemoglobin level).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.