RecruitingPhase 1NCT06454383

Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer

A Phase 1b Study of Gemcitabine and Leflunomide in Patients With Unresectable Pancreatic Cancer

Sponsor

City of Hope Medical Center

Enrollment

19 participants

Start Date

May 13, 2024

Study Type

INTERVENTIONAL

Conditions

Stage III Pancreatic Cancer AJCC v8 Stage IV Pancreatic Cancer AJCC v8 Advanced Pancreatic Adenocarcinoma Unresectable Pancreatic Ductal Adenocarcinoma

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests whether adding leflunomide (an anti-inflammatory drug normally used for arthritis) to gemcitabine chemotherapy can improve outcomes in patients with advanced pancreatic cancer that cannot be removed with surgery. **You may be eligible if...** - You are 18 or older with advanced, unresectable pancreatic ductal adenocarcinoma confirmed by biopsy - You are planning to receive gemcitabine (single-agent) chemotherapy - You are in good health (ECOG 0 or 1) with adequate blood counts and organ function - You have measurable or assessable disease on imaging **You may NOT be eligible if...** - You have had prior treatment for advanced pancreatic cancer (some exceptions may apply) - You have significant liver, kidney, or bone marrow problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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