Phase 3 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 metastatic pancreatic ductal adenocarcinoma (a specific type of pancreatic cancer that has spread), confirmed by a tissue or cell sample.
• People who have not yet received treatment for their metastatic disease, whose metastatic diagnosis was made within the past 3 months, and who are expected to receive the standard chemotherapy drugs gemcitabine and nab-paclitaxel.
• People who have previously had cancer surgery (such as a Whipple procedure), with or without chemotherapy before or after surgery, may still be considered.
• People with a life expectancy of at least 3 months.
• People whose cancer can be measured on a CT or MRI scan using standard measurement guidelines.
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning fully active or able to do light activity) (confirm with trial site).
• Adults aged 18 or older, of any gender.
• Women who could become pregnant must have a negative blood pregnancy test within 14 days before starting the study treatment, and must use adequate contraception from 2 weeks before the first dose until 6 months after the last dose.
• People with adequate bone marrow, liver, and kidney function as defined by the trial protocol (confirm with trial site).
• People whose heart's electrical activity (measured by an ECG) shows a specific interval within normal limits — at or below 470 ms for women and 450 ms for men.
• People who are willing and able to give written informed consent to participate.

Who may not be able to join:

• People who are known to carry mutations in the BRCA 1 or BRCA 2 genes, if genetic testing results are already available.
• People currently taking metformin (a diabetes medication) — metformin must be stopped at least 5 days before the trial begins and cannot be taken while on the study (other diabetes medications are permitted).
• People with any history of retinopathy (damage to the back of the eye), or those at risk of retinal detachment, including a personal or family history of retinal detachment, very severe short-sightedness, eye surgery within 6 months before the trial starts, or a history of serious eye injury. People found to have retinopathy at a baseline eye exam will also be excluded.
• People with severe or uncontrolled serious illness or any other condition that the trial doctor believes makes participation unsafe or unlikely to be completed. (Note: people with well-controlled diabetes are not excluded on this basis.)
• People with medical or psychiatric conditions that affect their ability to consent to the trial or to follow the trial procedures, or who have a history of not following medical instructions.
• People whose pancreatic tumour is a different type, such as an islet-cell tumour, pancreatic neuroendocrine tumour, or a mixed tumour type.
• People with active, symptomatic cancer that has spread to the brain or central nervous system.
• People with a serum albumin (a protein measured in the blood) level below 30 g/L.
• People who develop a blood clot in a deep vein, the portal vein, or the lungs (or another clotting event) during the screening period.
• People with a known active bacterial, fungal, or viral infection that requires treatment with systemic medication.
• People with a known active infection with HIV, hepatitis B, or hepatitis C.
• People with certain lung conditions, including interstitial lung disease, pulmonary fibrosis, or a lung hypersensitivity reaction.
• People who have had a heart attack in the past 12 months, who have severe or unstable chest pain (angina), or who have significant heart failure classified as class III or IV on a standard medical scale.
• People who are pregnant or breastfeeding.
• People who have had major surgery within 4 weeks before starting the study treatment and have not fully recovered.
• People with a known allergy or sensitivity to any component of the study drugs.
• People who have participated in another clinical trial within 4 weeks before receiving their first dose in this study.
• People who have any history of taking hydroxychloroquine (also known by brand names such as Plaquenil®).

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