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NCT05685602 · ClinicalTrials.gov registry record · Phase 1

CA-4948 Added to Standard Chemotherapy to Treat Metastatic or Unresectable Pancreatic Cancer

A Phase 1 study of Stage IV Pancreatic Cancer AJCC v8 and Stage III Pancreatic Cancer AJCC v8, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 1
Development phase
43
Enrollment target
20
Study locations

NCT05685602 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 National Cancer Institute (NCI). The registered enrollment target is 43 participants, below the 87-participant average among 31 other Stage IV Pancreatic Cancer AJCC v8 trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT05685602, a Phase 1 study of Stage IV Pancreatic Cancer AJCC v8 and Stage III Pancreatic Cancer AJCC v8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 1
Development phase
43 participants
Enrollment target
20
Study locations

Study Summary

This phase I trial tests the safety, side effects, and best dose of emavusertib (CA-4948) in combination with gemcitabine and nab-paclitaxel in treating patients with pancreatic ductal adenocarcinoma that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). CA-4948 is in a class of medications called kinase inhibitors. It works by blocking the action of abnormal proteins called interleukin-1 receptor-associated kinase 4 (IRAK4) and FMS-like tyrosine kinase 3 (FLT3) that signal cells to multiply. This may help keep cancer cells from growing. The usual approach for patients with pancreatic ductal adenocarcinoma is treatment with chemotherapy drugs gemcitabine and nab-paclitaxel. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Giving CA-4948 in combination with gemcitabine and nab-paclitaxel may shrink or stabilize metastatic or unresectable pancreatic ductal adenocarcinoma.

Conditions Studied

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

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy Procedure
  • BIOLOGICAL Emavusertib
  • DRUG Gemcitabine Hydrochloride

Study Locations (20)

Missouri

  • Siteman Cancer Center at Saint Peters Hospital - City of Saint Peters
  • Siteman Cancer Center at West County Hospital - Creve Coeur
  • Washington University School of Medicine - St Louis
  • Siteman Cancer Center-South County - St Louis
  • Siteman Cancer Center at Christian Hospital - St Louis

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
  • UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange

Maryland

  • Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
  • National Cancer Institute Developmental Therapeutics Clinic - Bethesda
  • National Institutes of Health Clinical Center - Bethesda

New York

  • NYU Langone Hospital - Long Island - Mineola
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center - New York

Illinois

  • Northwestern University - Chicago
  • Memorial Hospital East - Shiloh

Colorado

  • UCHealth University of Colorado Hospital - Aurora

Kentucky

  • University of Kentucky/Markey Cancer Center - Lexington

North Carolina

  • UNC Lineberger Comprehensive Cancer Center - Chapel Hill

Trial Details

FieldValue
Enrollment Target 43 participants
Start Date 2023-06-12
Est. Completion 2026-04-30
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05685602

The ClinicalTrials.gov registry entry for NCT05685602 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 87-participant average among 31 other Stage IV Pancreatic Cancer AJCC v8 trials with a reported enrollment target (51% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 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.

NCT05685602 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Missouri, California, Maryland.

Frequently Asked Questions

What is clinical trial NCT05685602 about?

NCT05685602 is a clinical study titled "CA-4948 Added to Standard Chemotherapy to Treat Metastatic or Unresectable Pancreatic Cancer". This phase I trial tests the safety, side effects, and best dose of emavusertib (CA-4948) in combination with gemcitabine and nab-paclitaxel in treating patients with pancreatic ductal adenocarcinoma that has spread from where it first started (primary site) to other places in the body (metastatic) ...

What is the current status of trial NCT05685602?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2023-06-12. Estimated completion is 2026-04-30.

What conditions does trial NCT05685602 study?

This clinical trial studies the following conditions: Stage IV Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Metastatic Pancreatic Ductal Adenocarcinoma, Unresectable Pancreatic Ductal Adenocarcinoma.

What interventions are being tested in trial NCT05685602?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Emavusertib (BIOLOGICAL), Gemcitabine Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT05685602?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05685602 being conducted?

This trial has 20 study locations across California, Colorado, Illinois, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.