Actively Recruiting
Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer
Led by City of Hope Medical Center · Updated on 2026-04-13
19
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or legally authorized representative provides documented informed consent
- Adult patients aged 18 years or older
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed advanced unresectable pancreatic ductal adenocarcinoma
- Measurable or evaluable disease by RECIST v1.1 criteria
- Planned treatment with single agent gemcitabine
- Fully recovered from prior anti-cancer therapy toxic effects except alopecia or neuropathy (grade 1 or less)
- No bone marrow involvement with ANC ≥ 1,500/mm³ and platelets ≥ 100,000/mm³ (transfusions not permitted within 14 days unless due to disease)
- Hemoglobin ≥ 9 g/dL (transfusions not permitted within 14 days unless due to disease)
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN) or direct bilirubin ≤ ULN (with exceptions for Gilbert's disease)
- AST ≤ 1.5 x ULN or ≤ 3 x ULN if liver metastases present
- ALT ≤ 1.5 x ULN or ≤ 2 x ULN if liver metastases present
- Creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min if creatinine > 1.5 x ULN
- Women of childbearing potential must have a negative pregnancy test
- Agreement to use effective contraception or abstain during study and specified periods after treatment
- Agreement to use archival tumor tissue or exceptions approved by study investigator
You will not qualify if you...
- Chemotherapy, radiation, biological therapy, or immunotherapy within 21 days before starting study treatment
- Use of drugs metabolized by certain enzymes and transporters within 21 days before treatment
- Use of herbal medications except cannabidiol (CBD)
- History of allergic reactions to similar compounds as study drugs
- Difficulty tolerating oral medications such as swallowing problems or ongoing nausea/vomiting
- Positive or latent tuberculosis
- Active diarrhea
- Clinically significant uncontrolled illness
- Active infection requiring antibiotics
- Known HIV, hepatitis B or C infection with detectable viral load
- Diagnosis of Gilbert's disease
- Prior malignancy in last 5 years except certain low-risk cancers
- Pregnant or breastfeeding women
- Any condition or circumstance judged by the investigator to contraindicate participation
- Inability to comply with all study procedures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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