Phase 2 Pancreatic Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 19 to 75 years old at the time of signing consent forms
• People whose pancreatic cancer has been confirmed by laboratory testing of tissue or cells, and whose cancer cannot be surgically removed, has spread locally, or has spread to other parts of the body, and who are planned to receive a chemotherapy combination called mFOLFIRINOX
• People who have not previously had chemotherapy for locally advanced or metastatic pancreatic cancer — though prior chemotherapy given before or after surgery is allowed, as long as the cancer did not come back or worsen within 6 months of finishing that treatment
• People who have at least one area of cancer that can be measured on scans, according to standard medical measurement guidelines
• People who have a relatively good general physical condition, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity) (confirm with trial site)
• People whose doctors expect them to live for at least 12 weeks
• People whose blood tests show their blood, kidneys, liver, and clotting system are all working at an adequate level
• People who have been fully informed about the trial and have voluntarily signed a consent form

Who may not be able to join:

• People who have a known allergy or sensitivity to the trial drug, the chemotherapy drugs used alongside it, their ingredients, or similar types of drugs
• People who have had another type of cancer in the past 5 years — though people with a history of certain skin cancers, thyroid cancer, or very early-stage cancers that were successfully treated and have not returned for more than 3 years may still be considered (confirm with trial site)
• People who have had major surgery requiring general anaesthesia or breathing support within 4 weeks before the study start (or certain types of chest or other surgeries within 2 weeks)
• People who have had a significant heart rhythm problem, heart attack, unstable chest pain, or severe heart failure within 24 weeks before the study start
• People who have had a blood clot in the lungs, a deep vein blood clot, or other serious lung conditions such as respiratory failure, or poorly controlled asthma or chronic lung disease, within 24 weeks before the study start
• People who are known to have a deficiency of an enzyme called DPD, which affects how certain chemotherapy drugs are broken down by the body
• People known to carry certain specific genetic variations (UGT1A1*6 or UGT1A1*28) in particular combinations, which can affect how the body processes some chemotherapy drugs
• People with a known intolerance to fructose (a type of sugar)
• People with moderate or severe nerve damage in their hands or feet
• People with long-term diarrhoea or inflammatory bowel conditions such as Crohn's disease or ulcerative colitis
• People with a bowel blockage or obstruction
• People with significant lung inflammation or scarring that requires steroid treatment
• People with kidney disease requiring dialysis
• People with brain or central nervous system spread of cancer that is causing symptoms or is not stable — though people whose brain metastases have been stable for at least 4 weeks and who stopped steroid treatment at least 4 weeks before the study start may still be considered (confirm with trial site)
• People with uncontrolled high blood pressure (readings of 160/100 mmHg or above)
• People with a specific abnormality in the heart's electrical activity shown on an ECG test (QTc greater than 450 ms)
• People with active hepatitis B or hepatitis C infection
• People with a known HIV infection
• People who have difficulty swallowing or conditions that affect how the body absorbs medicines (such as coeliac disease, Crohn's disease, or significant bowel removal surgery)
• People with a history of or suspected gastro-oesophageal reflux disease, stomach ulcers, or oesophagus inflammation
• People with Parkinson's disease, tremor, restless leg syndrome, or similar movement disorders
• People with significant uncontrolled fluid build-up in the abdomen or around the lungs
• People who, in the treating doctor's judgement, have another serious condition that could affect the study results or make the chemotherapy unsafe
• People who have had radiotherapy within 2 weeks before screening (some exceptions apply — confirm with trial site)
• People who have taken certain acid-reducing medications called proton pump inhibitors (PPIs), other than the trial drug itself, within 2 weeks before screening
• People who have taken blood-thinning or anti-clotting medications within 2 weeks before screening, or who are expected to need them during the study — though certain low-molecular-weight heparin injections for preventing or managing vein clots are allowed
• People who have used certain HIV medications containing rilpivirine or atazanavir within 2 weeks before screening
• People who are currently taking, or expect to need, certain medications that strongly affect how the liver processes drugs (strong CYP3A4 or CYP2C19 inhibitors or inducers) (confirm with trial site)
• People who are currently taking, or expect to need, high-dose methotrexate (a type of medication used for some cancers and other conditions)
• People currently taking St. John's Wort (a herbal supplement)
• People who need ongoing long-term steroid treatment at doses above a certain level (though some short-term or localised uses of steroids are allowed — confirm with trial site)
• People who are currently taking, or expect to need, a medication called sorivudine (an antiviral drug)
• Women who are pregnant or breastfeeding
• Women who could become pregnant, or men, who are unwilling to use appropriate contraception or remain abstinent for the required period after the last dose of study medication (15 months for women, 12 months for men)
• People who have taken part in another clinical trial or used an experimental drug or device within 4 weeks before screening
• People who, in the treating doctor's judgement, are otherwise unsuitable for the trial for any reason

Important: Always verify eligibility with the trial site directly before applying.