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 who are able to understand the study and are willing to sign a written consent form agreeing to take part
• Adults aged 18 or older, of any gender
• People who are generally well enough to carry out normal daily activities with little or no limitation (this is measured using a standard health scale called ECOG, scores 0–1)
• People whose cancer can be measured using standard imaging scans (by a set of guidelines called RECIST 1.1)
• People whose pancreatic cancer has been confirmed through a tissue or cell sample as a specific type called adenocarcinoma of the exocrine pancreas
• People whose cancer has either spread to other parts of the body or cannot be removed by surgery, and who have not yet received any treatment for this stage of the disease
• People who have not previously had any systemic (whole-body) cancer treatment for their advanced or metastatic disease
• People who are willing to provide stored tumour tissue if available, or who are able to undergo a fresh tissue sample collection — if neither is possible, enrollment will be decided by the lead doctor (principal investigator)
• People whose blood and organ function results meet the following minimum levels (as measured by blood tests):
  • White blood cell count above a certain level
  • Neutrophil count (a type of immune cell) above a certain level
  • Platelet count above a certain level
  • Haemoglobin (a measure of red blood cell health) at or above a certain level, without needing blood transfusions to maintain it
  • Kidneys working well enough, as measured by a standard calculation
  • Liver function values within acceptable ranges (slightly higher limits may apply if cancer has spread to the liver)
• People who have a condition called Gilbert's syndrome may still be considered, but this must first be discussed with and approved by the lead doctor
• Women who could become pregnant, and men whose partners could become pregnant, who agree to use effective birth control or to abstain from sex as outlined in the trial guidelines

Who may not be able to join:

• People who are currently enrolled in another clinical trial involving a treatment
• People who are currently using, or plan to use, other cancer treatments or experimental medicines during the study
• People with a psychiatric illness or personal circumstances that would make it difficult to follow the study requirements
• People who are pregnant or breastfeeding
• People who have had a known allergic reaction to any ingredient in the study drug
• People who have had a serious (Grade 3 or higher) active viral, bacterial, or fungal infection within the 2 weeks before starting the study drug
• People who have had major surgery within 4 weeks before enrolling in the trial
• People who have cancer that has spread to the brain and is either untreated or causing symptoms
• People with digestive system conditions that the doctor believes would significantly affect how the body absorbs a tablet or capsule taken by mouth (for example, bowel blockage, active Crohn's disease, ulcerative colitis, or extensive removal of parts of the stomach or small intestine)
• People who are unable or unwilling to swallow the study drug
• People with other serious uncontrolled health conditions, including active infections, wounds that are not healing as expected, moderate-to-severe heart failure, unstable chest pain, significant heart rhythm problems, significant breathing difficulties, or uncontrolled infection
• People with a known active HIV infection with a detectable level of virus in the blood, or active hepatitis B or C infection (people who have been vaccinated against hepatitis B may still be eligible)
• People with a currently active and symptomatic COVID-19 (SARS-CoV-2) infection
• People with clinically significant fluid build-up in the abdomen or around the lungs
• People with a history of another cancer, unless it was a non-melanoma skin cancer that was adequately treated, a cervical or prostate cancer that was fully cured, or another solid tumour that was fully cured with no signs of return for more than 2 years
• People with any other active health condition that the lead doctor believes would make the treatment unsafe or prevent the person from receiving the study drug
• People with any other condition — such as personal, psychological, or geographic circumstances — that would prevent them from following the study requirements
• People currently taking certain medications that are not permitted in this trial, including medicines known to affect heart rhythm in a specific way, or strong medicines that affect how the body processes certain drugs — people who are able to switch to a different medication before starting the trial may not be excluded (confirm specific medications with trial site)
• People whose heart's electrical activity, measured by a specific reading on a heart tracing (ECG) called QTcF, is above a certain threshold, or who have risk factors for a specific heart rhythm problem called torsade de pointes — including a family history of a condition called Long QT Syndrome or uncorrected low potassium levels in the blood

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