NCT07875907
Repurposing Mefloquine for Pancreatic Cancer Treatment
Not Yet Recruiting · Phase 1 · University of Florida · registry updated 2026-10-15
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
Pancreatic cancer (specifically pancreatic ductal adenocarcinoma, PDAC) is a very aggressive disease that is often diagnosed too late for surgery, and the medicines currently available, mainly two chemotherapy combinations called modified FOLFIRINOX (mFFX) and gemcitabine + nab-paclitaxel (GnP), can extend life but rarely cure patients. This study examines mefloquine, a well-studied antimalarial drug, as a new way to attack pancreatic cancer. Laboratory work has shown that mefloquine can block an enzyme (TYMS) that cancer cells need to make DNA, and unlike many existing drugs it does not cause the cancer cells to produce more of that enzyme and become resistant. In several mouse models, as well as tumors grown from human patients, oral mefloquine at doses that were well tolerated (up to 300 mg/kg) slowed tumor growth and helped the animals live longer. This trial aims to find a safe dose of mefloquine for PDAC patients. A classic "3 + 3" design will be used in three separate arms: one taking mFFX, one taking GnP, and one taking mefloquine as monotherapy after exhausting standard of care treatment options....
Inclusion
- Adults (≥ 18 years old) with histologically confirmed, unresectable or metastatic PDAC.
- Subjects must have measurable disease per RECIST 1.1.
- Subjects must be about to initiate a treatment regimen containing either mFFX or GnP, OR (for monotherapy arm) have relapsed/refractory disease following standard therapies, not candidates for standard-of-care therapies, or are intolerant of such therapies.
- Subjects must plan to continue cancer care at UF Health for at least the next three months.
- Subjects with known or suspected Gilbert's disease must be formally tested for UGT1A1\*28 with results available to study team prior to treatment initiation
- Adequate organ and hematologic function, as defined by:
Exclusion
- Patients with unstable or active CNS metastases
- Patients with swallowing problems or any gastrointestinal disorder or malabsorption that may affect a patient's ability to take and absorb an oral medication
- Known hypersensitivity to Mefloquine or related compounds (e.g., quinine and quinidine), or to any of the excipients contained in the formulation.
- Use of strong CYP3A4 inhibitors or inducers which cannot be discontinued prior to study entry.
- Known history of psychosis, major depression, major anxiety disorder or other psychiatric disorder that the PI believes will place the patient at higher risk of psychiatric toxicity
- Any history of seizures, even if actively treated or remote in history