Phase 2 Pancreatic Cancer Trial, Completed

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:

• Adults aged 18 or older with a body weight between 40 kg and 100 kg.
• People who have been diagnosed with a specific type of pancreatic cancer called ductal adenocarcinoma that has spread to other parts of the body (metastatic), diagnosed within the past 4 months (Part A) or within the past 2 months (Part B).
• People who have been diagnosed with ductal adenocarcinoma of the pancreas that is locally advanced (meaning it has grown but not spread to distant organs), diagnosed within the past 3 months (Part B only).
• People whose cancer can be measured using a specific type of CT scan, following standard measurement guidelines.
• People who have had non-curative surgery, provided it was at least 4 weeks ago and recovery from major surgical complications has occurred.
• People with an estimated life expectancy of at least 4 months.
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity — confirm with trial site).
• People with normal blood clotting test results within specific ranges (PT 10–16 seconds and aPTT 22–38 seconds).
• People who are willing to avoid contact sports and strenuous physical activity while taking the study drug PCI-27483.
• People who understand the study, are willing to participate for its full duration, and are able to provide written consent.

Who may not be able to join:

• People with any significant medical condition that the lead investigator believes would interfere with the study.
• People with a known history of cancer that has spread to the brain.
• People who have had any bleeding inside the skull, detected by a head CT scan in the past 30 days.
• People whose cancer has previously gotten worse while being treated with the chemotherapy drug gemcitabine.
• People who have had radiation treatment to the main tumour, or who are unwilling to delay such treatment until more than 3 months after starting the study treatment.
• People who have had a blood clot in a vein or artery (such as a deep vein thrombosis or pulmonary embolism) or who have had other reasons requiring blood-thinning treatment within the past year (a clot in certain nearby veins — mesenteric or portal — is acceptable).
• People with high blood pressure that is not controlled by medication (systolic above 160 or diastolic above 100 mmHg).
• People who are currently taking blood-thinning (anticoagulant) medication, or who have taken it within the past 2 months, except for short-term use around the time of surgery that ended at least 2 weeks before enrolment.
• People for whom blood-thinning treatment is medically not suitable.
• People who have taken antiplatelet medicines (such as aspirin or clopidogrel) within the past 72 hours.
• People with a known history of significant or recurring bleeding episodes, including serious bleeding after surgery, childbirth, or dental procedures.
• People whose cancer has been confirmed by CT scan to have grown into nearby organs such as the stomach or small intestine.
• People known to have enlarged veins in the oesophagus (oesophageal varices).
• People with a known inherited blood clotting factor deficiency.
• People with a known acquired or inherited platelet disorder.
• People with a known history of immune system deficiency.
• Women of childbearing potential or sexually active men who are unwilling to use adequate contraception throughout the study.
• Women who are pregnant or breastfeeding (women of childbearing potential must have a negative blood pregnancy test within 14 days of the first dose, or have pregnancy ruled out by ultrasound if the test is positive).
• People with certain abnormal blood test results, including: kidney function below a certain level; liver enzyme levels (AST/ALT) at or above four times the upper normal limit; bilirubin at or above 3 mg/dL; a specific liver enzyme (alkaline phosphatase) more than five times the upper normal limit; low blood protein (albumin below 2.0 g/dL); low red blood cell levels (haemoglobin below 9.0 g/dL); or low platelet count (below 100,000 per microlitre).
• People with signs of active bleeding in the digestive tract (excluding bleeding from haemorrhoids).
• People with chronic active hepatitis B or C infection.
• People known to have HIV infection.
• People who have taken part in another clinical study of an experimental drug, device, or treatment within the past 30 days, or who plan to do so during this study.
• People who have risk factors for, or have used medications known to affect heart rhythm in a specific way (QTc prolongation or Torsades de Pointes risk) within 7 days of starting treatment (confirm specific medications with trial site).
• People with a prolonged heart rhythm interval (QTc at or above 450 milliseconds) or other significant heart electrical abnormalities, including certain types of heart block or a very slow heart rate (below 50 beats per minute) — though a specialist cardiology review may determine eligibility in borderline cases (confirm with trial site).

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