Phase 2 Pancreatic Cancer Trial, Recruiting

Written by an AI model from the 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 been diagnosed with pancreatic adenocarcinoma (a specific type of pancreatic cancer), confirmed through laboratory testing of tissue or cell samples.
• People whose pancreatic cancer is advanced — meaning it cannot be surgically removed or has spread to other parts of the body.
• People whose cancer has a harmful or likely harmful change (mutation) in the PALB2 gene, whether inherited or developed in the tumour itself.
• People who have at least one tumour that can be measured on a CT scan or MRI scan and tracked over time.
• People who are expected to live for at least 16 weeks.
• People who are generally able to carry out daily activities with no or only minor limitations, as assessed within 3 days of starting treatment (this is measured using a standard scale called ECOG, with a score of 0 or 1).
• People who have already received at least one systemic (whole-body) treatment for their advanced pancreatic cancer.
• People whose kidneys, liver, bone marrow, and other organs are functioning well enough, based on blood tests done within 10 days before starting the trial.
• People who are at least 18 years old at the time of signing the consent form.
• Male participants who agree to use contraception during treatment and for at least 3 months after the last dose, and who agree not to donate sperm during this period.
• Female participants who are not pregnant, not breastfeeding, and either cannot become pregnant or agree to use effective contraception during treatment and for at least one month after the last dose, with regular pregnancy testing throughout.
• People (or their legal representative) who are willing and able to provide written consent to take part.

Who may not be able to join:

• People who have another cancer that is currently growing or requires active treatment (some exceptions apply for certain early-stage or previously cured cancers — confirm with trial site).
• People who have or show signs of a blood or bone marrow condition called myelodysplastic syndrome or acute myeloid leukaemia.
• People who have brain metastases (cancer that has spread to the brain) causing active symptoms that are not controlled, or cancer affecting the membranes around the brain — though people with previously treated and stable brain metastases may still be considered (confirm with trial site).
• People who have lost more than 10% of their body weight during the screening period, or whose general health has noticeably declined just before starting treatment.
• People who have an active infection that requires treatment with antibiotics or antiviral medicines given throughout the body.
• People who have a known psychiatric condition or substance use disorder that would make it difficult to follow the trial requirements.
• People who still have significant side effects (above a mild level) from previous cancer treatments, with the exception of hair loss.
• People who have a serious uncontrolled medical condition, such as an uncontrolled irregular heartbeat, a heart attack within the past 3 months, uncontrolled seizures, or serious lung disease, among others.
• People who are unable to swallow tablets or capsules, or who have a digestive condition that would prevent the study medication from being properly absorbed.
• People with a weakened immune system, including those who are known to be HIV positive.
• People with active hepatitis B or hepatitis C infection (some people with past or resolved hepatitis B or C may still be eligible — confirm with trial site).
• People who have previously been treated with a type of drug called a PARP inhibitor, including olaparib (the drug being studied in this trial).
• People who have had chemotherapy, targeted therapy, or radiotherapy (other than for pain relief) within 3 weeks before starting the trial.
• People who have received a certain type of antibody-based therapy within the past 4 weeks, or who have not fully recovered from side effects of such therapy.
• People whose cancer has only spread to bone and nowhere else.
• People who have had major surgery within 2 weeks before starting the trial, or who have not fully recovered from surgery.
• People who are currently taking certain medications that can interfere with how the study drug is processed in the body, including some antifungals, antibiotics, antiviral drugs, and certain heart and seizure medications (a washout period may be required — confirm with trial site).
• People who have previously had a bone marrow transplant or a specific type of stem cell transplant.
• People who have received a whole blood transfusion in the 120 days before joining the trial (transfusions of packed red blood cells or platelets may be acceptable if not given within 28 days of the first dose — confirm with trial site).
• People who are currently taking part in, or have recently taken part in, another clinical trial involving an investigational medicine in the last 4 weeks.
• People who have a known allergic reaction to olaparib or any of its ingredients.
• People whose resting heart tracing (ECG) shows certain uncontrolled heart rhythm or electrical problems, or who were born with a condition called long QT syndrome.
• People with any other medical condition, past or current, that the trial doctor believes could interfere with participation or affect the results.
• People whose PALB2 gene change is classified as harmless or of uncertain significance — only harmful or likely harmful mutations are eligible.
• People whose cancer is a different type of pancreatic tumour (for example, neuroendocrine or adenosquamous) rather than adenocarcinoma.
• People who are pregnant, breastfeeding, or planning to conceive a child during the trial period and up to 30–90 days after the last dose.
• People whom the trial doctor believes are unlikely to be able to follow the trial's procedures and requirements.

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