Phase 3 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 been diagnosed with advanced, inoperable, or metastatic pancreatic adenocarcinoma (a specific type of pancreatic cancer), confirmed by a tissue sample from the pancreas or another affected area.
• People whose cancer can be measured on scans, according to standard medical measurement guidelines.
• People who are male, or female and neither pregnant nor breastfeeding, and are 18 years of age or older.
• Women who could potentially become pregnant must have a negative pregnancy blood test before starting the trial.
• Women who could potentially become pregnant must agree to use an approved form of contraception throughout the trial and for 9 months after the last dose of the study drug OT-101.
• Male participants must use effective contraception for 6 months after the final dose of one of the study drugs (oxaliplatin).
• People who are willing and able to sign a consent form agreeing to take part.
• People who are generally well enough to carry out light daily activities, as measured by a standard medical scale (ECOG score of 0 or 1).
• People who are willing and able to follow all study requirements.
• People whose blood, liver, and kidney test results fall within acceptable ranges, as measured within 28 days before joining the trial (confirm specific values with trial site).
• People who, in the treating doctor's opinion, are expected to live for at least 3 months.

Who may not be able to join:

• People whose pancreatic cancer is a different type than adenocarcinoma, such as a lymphoma, sarcoma, or certain other rare types.
• People whose overall health or ability to function has declined between their screening visit and within 72 hours before being enrolled in the trial.
• People taking the blood thinner Coumadin (warfarin) who are not willing to switch to a different type of blood thinner as required by the trial.
• People with a history of another cancer, unless it was a skin cancer or other cancer that has been successfully treated and the person has been cancer-free for at least 3 years (some exceptions may apply at the investigator's discretion).
• People with a serious medical condition, significant abnormal test results, a psychiatric illness, or other health issues that the treating doctor believes would make participation unsafe or inappropriate.
• People with an abnormal heart rhythm reading on an ECG test (specifically a QT or QTc interval greater than 470 ms); cases involving a heart pacemaker will be assessed individually (confirm with trial site).
• People with a serious, uncontrolled infection, or an infection currently requiring treatment through a drip (intravenous antibiotics).
• People with a known history of HIV infection.
• People with a known history of hepatitis A, B, or C infection.
• People who have had significant bleeding, such as from the stomach, intestines, or brain, within 2 weeks before joining the trial.
• Women who are pregnant or breastfeeding.
• People who have had a heart attack, heart bypass surgery, or a blood clot in an artery within the last 6 months, or who have significant heart failure, unstable chest pain, or an irregular heartbeat requiring medication.
• People who have a large build-up of fluid in the abdomen that requires drainage at least once every 2 weeks.
• People who have had major surgery (requiring general anaesthetic and a significant incision) within 28 days before joining the trial, or who are expected to need major surgery during the study.
• People who have previously been treated with certain immune-based cancer therapies known as checkpoint inhibitors (such as anti-CTLA4, anti-PD1, or anti-PD-L1 drugs).
• People who have nerve damage in their hands or feet that is more than mild (greater than Grade 1 peripheral neuropathy).
• People with a known enzyme deficiency called DPD deficiency, which increases the risk of serious side effects from one of the chemotherapy drugs used in this trial (5-fluorouracil).
• People with a history of, or significant risk of, autoimmune diseases — conditions where the immune system attacks the body — such as lupus, rheumatoid arthritis, multiple sclerosis, or inflammatory bowel disease, among others (some mild autoimmune skin or thyroid conditions may be accepted — confirm with trial site).
• People currently taking certain medications, including: other experimental drugs not part of this trial; blood thinners (other than heparin used to keep a central line open); anti-inflammatory drugs (NSAIDs); certain blood-thinning medications such as clopidogrel or dipyridamole; or steroid medications above a specified dose or with a dose that is being increased (confirm specific thresholds with trial site).
• People with a known allergy or sensitivity to drugs that are chemically similar to OT-101, such as antisense oligonucleotides or siRNA therapies.
• People who are unable to attend follow-up visits or complete required check-ups to monitor their health during the trial (telemedicine visits are accepted).
• People who are not willing or able to follow all study requirements, including required procedures and visits.
• People who have other health reasons that make taking any of the chemotherapy drugs in this trial (mFOLFIRINOX) unsuitable, as outlined in those drugs' official prescribing information.
• People who have participated in another experimental clinical trial within 30 days of their last dose of an experimental drug.
• People with significant psychiatric conditions, or those who do not have the legal capacity to give informed consent.
• People with a condition that causes their immune system to not work properly from birth (primary immunodeficiency).
• People with active cancer that has spread to the brain or spinal cord; those with previously treated and stable brain metastases for at least 6 weeks after stopping steroid treatment may be considered with sponsor and investigator approval.

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