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NCT06454383 · ClinicalTrials.gov registry record · Phase 1
Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer
A Phase 1 study of Stage IV Pancreatic Cancer AJCC v8 and Stage III Pancreatic Cancer AJCC v8, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT06454383: Recruiting Phase 1 study of Stage IV Pancreatic Cancer AJCC v8 and Stage III Pancreatic Cancer AJCC v8, sponsored by City of Hope Medical Center.
NCT06454383 is a Phase 1 study of Stage IV Pancreatic Cancer AJCC v8 and Stage III Pancreatic Cancer AJCC v8 that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 19 participants, below the 88-participant average among 31 other Stage IV Pancreatic Cancer AJCC v8 trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06454383, a Phase 1 study of Stage IV Pancreatic Cancer AJCC v8 and Stage III Pancreatic Cancer AJCC v8, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Toxicities will be graded according to Common Terminology Criteria for Adverse Events version 5.0.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- DRUG Gemcitabine
- DRUG Cholestyramine
- PROCEDURE Diagnostic Imaging
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2024-05-13 |
| Est. Completion | 2026-11-13 |
| Phase | Phase 1 |
What NCT06454383 shows while recruiting
NCT06454383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 88-participant average among 31 other Stage IV Pancreatic Cancer AJCC v8 trials with a reported enrollment target (78% lower).
The record links to 4 conditions, with Stage IV Pancreatic Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06454383 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06454383 about?
NCT06454383 is a clinical study titled "Gemcitabine and Leflunomide in Patients With Advanced Unresectable Pancreatic Cancer". 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 b...
What is the current status of trial NCT06454383?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2024-05-13. Estimated completion is 2026-11-13.
What conditions does trial NCT06454383 study?
This clinical trial studies the following conditions: Stage IV Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Advanced Pancreatic Adenocarcinoma, Unresectable Pancreatic Ductal Adenocarcinoma.
What interventions are being tested in trial NCT06454383?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Gemcitabine (DRUG), Cholestyramine (DRUG), Diagnostic Imaging (PROCEDURE).
Who is sponsoring clinical trial NCT06454383?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06454383 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV Pancreatic Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06454383's enrollment target sits among peer trials
19 27th of 31 higher than 5 of 31 other Stage IV Pancreatic Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Pancreatic Cancer AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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