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NCT04172532 · ClinicalTrials.gov registry record · Phase 1

Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer

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

Recruiting
Registry status
Phase 1
Development phase
92
Enrollment target
20
Study locations

NCT04172532 is a Phase 1 study of Stage III Pancreatic Cancer AJCC v8 and Locally Advanced Pancreatic Adenocarcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 92 participants, above the 56-participant average among 23 other Stage III Pancreatic Cancer AJCC v8 trials with a reported enrollment target (64% higher). The trial reports 20 study locations across 7 states.

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The verdict

NCT04172532, a Phase 1 study of Stage III Pancreatic Cancer AJCC v8 and Locally Advanced Pancreatic Adenocarcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

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

Study Summary

This phase I/II trial studies the safety, side effects and best dose of M3814 and to see how well it works when given together with radiation therapy in treating patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving M3814 and hypofractionated radiation therapy together may be safe, tolerable and/or more effective than radiation therapy alone in treating patients with locally advanced pancreatic cancer.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • PROCEDURE Biopsy Procedure
  • RADIATION Hypofractionated Radiation Therapy

Study Locations (20)

Kansas

  • University of Kansas Clinical Research Center - Fairway
  • HaysMed - Hays
  • University of Kansas Cancer Center - Kansas City
  • Lawrence Memorial Hospital - Lawrence
  • The University of Kansas Cancer Center - Olathe - Olathe
  • University of Kansas Cancer Center-Overland Park - Overland Park
  • Mercy Hospital Pittsburg - Pittsburg
  • Salina Regional Health Center - Salina
  • University of Kansas Health System Saint Francis Campus - Topeka
  • University of Kansas Hospital-Westwood Cancer Center - Westwood

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
  • City of Hope at Irvine Lennar - Irvine
  • UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
  • University of California Davis Comprehensive Cancer Center - Sacramento

Colorado

  • UCHealth University of Colorado Hospital - Aurora

District of Columbia

  • Sibley Memorial Hospital - Washington D.C.

Illinois

  • Northwestern University - Chicago

Kentucky

  • University of Kentucky/Markey Cancer Center - Lexington

Michigan

  • Wayne State University/Karmanos Cancer Institute - Detroit

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2021-01-11
Est. Completion 2026-08-01
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT04172532

The ClinicalTrials.gov registry entry for NCT04172532 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 92 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 56-participant average among 23 other Stage III Pancreatic Cancer AJCC v8 trials with a reported enrollment target (64% higher). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Stage III Pancreatic Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT04172532 reports 20 study locations spanning 7 distinct geographic areas - top geographies include Kansas, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT04172532 about?

NCT04172532 is a clinical study titled "Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer". This phase I/II trial studies the safety, side effects and best dose of M3814 and to see how well it works when given together with radiation therapy in treating patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced). M3814 may stop the growth of tumor cel...

What is the current status of trial NCT04172532?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 92 participants. The study started on 2021-01-11. Estimated completion is 2026-08-01.

What conditions does trial NCT04172532 study?

This clinical trial studies the following conditions: Stage III Pancreatic Cancer AJCC v8, Locally Advanced Pancreatic Adenocarcinoma.

What interventions are being tested in trial NCT04172532?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Hypofractionated Radiation Therapy (RADIATION).

Who is sponsoring clinical trial NCT04172532?

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

Where is trial NCT04172532 being conducted?

This trial has 20 study locations across California, Colorado, District of Columbia, Illinois, Kansas. 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

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