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 been diagnosed with pancreatic ductal adenocarcinoma (a specific type of pancreatic cancer), confirmed by a lab test, who have not yet received any systemic treatment for advanced or spread disease. Tumors with mixed cell types are allowed if the pancreatic adenocarcinoma type is the main portion.
• People who previously received certain chemotherapy (such as FOLFIRINOX or mFOLFIRINOX) before or after surgery are allowed, as long as the cancer came back more than 12 months after the last dose of that treatment.
• For the dose escalation part of the trial: people with advanced inoperable or metastatic pancreatic cancer where the treating doctor considers a FOLFIRINOX-based chemotherapy regimen to be a suitable option.
• For the dose expansion part of the trial: people with metastatic pancreatic cancer where the treating doctor considers a FOLFIRINOX-based chemotherapy regimen to be a suitable option.
• People whose cancer can be measured on scans according to standard criteria (RECIST 1.1).
• People aged 18 years or older.
• People who are in good enough general health to carry out light activity and care for themselves (confirm with trial site what this means for specific situations).
• People whose blood counts, liver function, and kidney function meet certain minimum levels as measured by blood tests (confirm specific values with trial site).
• People whose heart electrical activity (measured by an ECG) is within an acceptable range.
• People who agree to use adequate contraception during the trial and for a specified period after the last dose of each study drug. If pregnancy occurs or is suspected during the study, the treating doctor must be informed immediately.
• People who are able to understand and are willing to sign a written consent form agreeing to take part.

Who may not be able to join:

• People who have had another cancer, unless all treatment for that cancer was completed at least 2 years ago with no sign of it returning, or unless it is a slow-growing cancer that does not need treatment and is unlikely to affect pancreatic cancer treatment.
• People who have had an organ transplant or stem cell transplant from another person.
• People who are currently taking part in another clinical trial, or who have received an experimental treatment within 2 weeks or 5 half-lives of that treatment (whichever is shorter) before starting this trial.
• People who have recently taken certain medications that affect how the body processes drugs, including specific enzyme inhibitors or inducers, or medications known to affect heart rhythm — including grapefruit (confirm specific medications with trial site).
• People with cancer that has spread to the brain or central nervous system.
• People who have had a serious allergic reaction to drugs with a similar chemical makeup to the study drugs being used in this trial.
• People with significant nerve damage or nerve-related symptoms rated at grade 2 or above.
• People with a lung condition called interstitial lung disease that is causing symptoms or could make it difficult to detect lung problems related to treatment.
• People with digestive or stomach conditions that the treating doctor believes could prevent the study drug (zunsemetinib) from being properly absorbed.
• People who are unable to swallow pills.
• People with serious uncontrolled illness, such as an active infection, heart failure, unstable chest pain, or irregular heart rhythm.
• People who are pregnant or breastfeeding. Women who could become pregnant must have a negative blood pregnancy test within 7 days before starting the trial.
• People living with HIV whose CD4+ T-cell count is below 350 cells/mcL, or who have had a serious HIV-related infection in the 12 months before joining.
• People who have had major surgery within 28 days before starting the trial. Major surgery includes procedures done under general or regional anaesthesia that involve significant changes to the body, carry higher risks, or need a long recovery. Placement of a central line (a type of intravenous line) is allowed.
• People who have received a live vaccine (such as for flu or chickenpox) within 28 days before starting the trial.

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