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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 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.

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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.

Conditions Studied

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

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

FieldValue
Enrollment Target 19 participants
Start Date 2024-05-13
Est. Completion 2026-11-13
Phase Phase 1

Sponsor

City of Hope Medical Center

582 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06454383

The ClinicalTrials.gov registry entry for NCT06454383 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 88-participant average among 31 other Stage IV Pancreatic Cancer AJCC v8 trials with a reported enrollment target (78% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.