Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
This phase Ib trial tests the safety, side effects, and best dose of leflunomide in combination with gemcitabine in treating patients with pancreatic cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and cannot be removed by surgery (unresectable). Improving the effectiveness of gemcitabine without increasing side effects could lead to a greater impact for pancreatic cancer patients' survival and quality of life. Gemcitabine is commonly used as a first-line chemotherapy treatment for pancreatic cancer. Leflunomide is a drug approved for use against rheumatoid arthritis that is being looked at as a cancer treatment option. It has shown promising results when combined with gemcitabine. Giving gemcitabine in combination with leflunomide may be safe and effective in treating patients with advanced unresectable pancreatic cancer.
Sponsor: City of Hope Medical Center
You may qualify if…
- ✓ Documented informed consent of the participant and/or legally authorized representative.
- ✓ Adult patients lacking capacity to consent may participate if they have a caretaker that could ensure oral medication compliance.
- ✓ Agreement to allow the use of archival tissue from diagnostic tumor biopsies.
- ✓ If unavailable, exceptions may be granted with study principal investigator (PI) approval.
- ✓ Age: ≥ 18 years.
- ✓ Eastern Cooperative Oncology Group (ECOG) ≤ 1.
- ✓ Subjects must have histologically or cytologically confirmed diagnosis of advanced unresectable pancreatic ductal adenocarcinoma (PDA).
- ✓ Measurable or evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
You may not qualify if…
- ✕ Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy.
- ✕ Drugs metabolized by CYP2C8, CYP1A2, BCRP, OATP1B1/B3, and OAT3 transporters within 21 days prior to day 1 of protocol therapy.
- ✕ Herbal medications (excluding cannabidiol \[CBD\]).
- ✕ History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
- ✕ Issues with tolerating oral medication (e.g. inability to swallow pills, malabsorption issues, ongoing nausea or vomiting).
- ✕ Positive for tuberculosis or latent tuberculosis (TB).
- ✕ Active diarrhea.
- ✕ Clinically significant uncontrolled illness.
Where it's recruiting
Duarte
Source: ClinicalTrials.gov · NCT06454383 · last updated 2026-04-13