Phase 1 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 have given written consent to participate, or whose legally authorised representative has done so on their behalf (adults who are unable to consent themselves may be eligible if they have a caregiver who can ensure they take their medication as required).
• People who agree to allow stored tissue samples from their tumour biopsy to be used for the study (exceptions may be possible with approval from the lead researcher if samples are not available).
• People aged 18 or older.
• People whose general physical functioning is rated at a relatively high level, meaning they are either fully active or have only minor restrictions on physical activity (confirm with trial site).
• People who have been diagnosed with advanced, inoperable pancreatic ductal adenocarcinoma, confirmed through laboratory testing of tissue or cell samples.
• People whose cancer can be measured or assessed using standard imaging criteria.
• People who are planned to receive the chemotherapy drug gemcitabine on its own.
• People who have largely recovered from side effects of previous cancer treatments (with the exception of hair loss or nerve-related symptoms), with only mild effects remaining.
• People whose blood counts meet specific minimum levels, including white blood cells, platelets, and haemoglobin, as measured by recent blood tests (confirm specific values with trial site).
• People whose liver function blood test results fall within acceptable ranges as defined by the trial.
• People whose kidney function meets the minimum level required by the trial.
• Women who could become pregnant must have a negative pregnancy test before starting the trial.
• People who are able to commit to using effective contraception, or abstaining from heterosexual activity, throughout the trial and for at least 6 months after the last dose of gemcitabine (for women) or 3 months (for men), or until a specific study drug (leflunomide) is no longer detectable in the blood.

Who may not be able to join:

• People who have received chemotherapy, radiation, biological therapy, or immunotherapy within the 21 days before the trial starts.
• People who have taken certain medications that interact with specific liver enzymes or transport proteins within the 21 days before the trial starts (confirm which medications are affected with the trial site).
• People currently using herbal medications (CBD is an exception and is permitted).
• People with a history of allergic reactions to drugs that are chemically similar to the study drug.
• People who have difficulty taking oral (swallowed) medication, such as trouble swallowing pills, problems absorbing food or medication, or ongoing nausea and vomiting.
• People who test positive for tuberculosis (TB), including latent (inactive) TB.
• People currently experiencing active diarrhoea.
• People with a significant uncontrolled medical condition.
• People with an active infection currently being treated with antibiotics.
• People with a known history of HIV, hepatitis B, or hepatitis C (though people with detectable antibodies but an undetectable viral load may be considered — confirm with trial site).
• People with a diagnosis of Gilbert's disease (a liver condition affecting bilirubin processing).
• People with a history of another cancer, unless it was only a very early-stage cervical cancer or a non-melanoma skin cancer, or unless any other previous cancer was fully treated 5 or more years ago with no signs of return. People with a history of low-grade, localised prostate cancer may still be eligible even if diagnosed less than 5 years ago. Other cases may be considered with approval from the lead researcher.
• People who are pregnant or breastfeeding.
• People who, in the investigator's judgement, should not participate for safety reasons.
• People who may not be able to follow all study requirements and procedures.

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