DIGITOXIN for Pancreatic adenocarcinoma | Pancreatic cancer

Inclusion criteria

• {"criterion_text":"- Male or female, 18 years or older.\n- WHO performance status 0-2.\n- Histologically or cytologically confirmed inoperable adenocarcinoma of the pancreas. Histologically or cytologically confirmed from primary tumor in the pancreas or metastasis.\n- The patient shall be newly diagnosed and not have started any other treatment for the pancreatic cancer.\n- Radiographically measurable or evaluable disease, according RECIST (v1.1).\n- The patient is able to take care of his/her medication.\n- The patient has given written consent to participate in the trial.\n- 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.\n- 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.\n- 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

• {"criterion_text":"- Chronic or current active infectious disease requiring systemic antibiotics, antifungal or antiviral treatment.\n- Signific ant concurrent, uncontrolled medical condition including, but not limited: to renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.\n- 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.\n- Cardiac arrythmia which may worsen by digitoxin therapy.\n- 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.\n- Patient who has already been subjected to or started chemotherapy or other treatment for the pancreatic cancer.\n- Absolute B-neutrophil count (ANC) <1.5 × 10^9/L.\n- B-Platelets < 75 × 10^9/L.\n- B-Haemoglobin < 9 g/L (transfusions are permitted to achieve baseline haemoglobin level).\n- P-ALAT/ASAT > 2.5 × ULN; or > 5 × ULN in the presence of liver metastases.\n- Total P-bilirubin > 1.5 × ULN (use of biliary stent to achieve bilirubin levels is permitted).\n- S- LDH > 3 × ULN in the absence of haemolysis.\n- P-Potassium < 3.5 or > 4.5 mmol/L.\n- P-Sodium <137 or >145 mmol/L\n- P-Albumin <25 g/L\n- P-Calcium < 2.15 or > 2.50 mmol/L.\n- S-Magnesium <0.7 mmol/L or > 1.1 mmol/L\n- S-creatinine > 150 μmol/L.\n- Pregnancy or female patients that are breastfeeding and not willing to refrain.\n- Hypersensitivity to digitoxin or other cardiac glycoside or any other ingredients in the tablets (see SmPC).\n- Carotid sinus syndrome.\n- Simultaneous administration of intravenous calcium salts.\n- Thoracic aortic aneurysm.\n- Intended electrical cardioversion."}

Primary endpoints

• {"endpoint_text":"- Progression free survival at 1 year; from the date of enrollment, i.e. from start to take digitoxin tablets.","definition_or_measurement_approach":"Progression-free survival at 1 year measured from date of enrollment (start of digitoxin tablets)."}

Secondary endpoints

• {"endpoint_text":"- Overall survival at 1 year.\n- 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).\n- Objective response rate and duration of response determined by radiographic disease assessments per RECIST (v1.1).\n- Safety and tolerability of the treatment regimens by assessment of adverse events and changes in safety assessments including laboratory parameters.\n- Biochemical response: change in serum tumor markers (CA19-9, CEA, CA125) before start of digitoxin tablets as baseline and at every 3 months evaluation.\n- Quality of Life according to EORTC QLQ-C30 and EORTC QLQ-PAN-26.\n- 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.","definition_or_measurement_approach":"Overall survival at 1 year measured from enrollment; PFS defined and measured per RECIST v1.1 by objective radiographic assessment; objective response rate and duration measured by radiographic assessments per RECIST v1.1; safety by adverse events and laboratory parameters; biochemical response assessed by changes in CA19-9, CEA, CA125 at baseline and every 3 months; QoL measured using EORTC QLQ-C30 and QLQ-PAN-26; translational cytokine analyses at baseline and at 3 months."}

Sweden

Earliest CTIS Part Ii Submission Date

25-11-2024

Latest Decision Or Authorization Date

11-12-2024

Processing Time Days

16

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Vaestra Goetalandsregionen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Sweden