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NCT05411094 · ClinicalTrials.gov registry record · Phase 1
Testing the Safety of the Anti-Cancer Drugs Durvalumab and Olaparib During Radiation Therapy for Locally Advanced Unresectable Pancreatic Cancer
A Phase 1 study of Stage III Pancreatic Cancer AJCC v8 and Stage II Pancreatic Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 11
- Study locations
NCT05411094 is a Phase 1 study of Stage III Pancreatic Cancer AJCC v8 and Stage II Pancreatic Cancer AJCC v8 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants, below the 60-participant average among 23 other Stage III Pancreatic Cancer AJCC v8 trials with a reported enrollment target (70% lower). The trial reports 11 study locations across 6 states.
The verdict
NCT05411094, a Phase 1 study of Stage III Pancreatic Cancer AJCC v8 and Stage II Pancreatic Cancer AJCC v8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 11
- Study locations
Study Summary
This phase I trial tests the safety and tolerability of olaparib in combination with durvalumab and radiation therapy in patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable). Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. The combination of targeted therapy with olaparib, immunotherapy with durvalumab and radiation therapy may stimulate an anti-tumor immune response and promote tumor control in locally advanced unresectable pancreatic cancer.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Biopsy Procedure
- BIOLOGICAL Durvalumab
Study Locations (11)
California
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Michigan
- University of Michigan Rogel Cancer Center - Ann Arbor
- University of Michigan - Brighton Center for Specialty Care - Brighton
Wisconsin
- University of Wisconsin Carbone Cancer Center - Eastpark Medical Center - Madison
- University of Wisconsin Carbone Cancer Center - University Hospital - Madison
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Ontario
- University Health Network-Princess Margaret Hospital - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2023-05-22 |
| Est. Completion | 2028-07-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05411094
The ClinicalTrials.gov registry entry for NCT05411094 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 60-participant average among 23 other Stage III Pancreatic Cancer AJCC v8 trials with a reported enrollment target (70% 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 III Pancreatic Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05411094 reports 11 study locations spanning 6 distinct geographic areas - top geographies include California, Michigan, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT05411094 about?
NCT05411094 is a clinical study titled "Testing the Safety of the Anti-Cancer Drugs Durvalumab and Olaparib During Radiation Therapy for Locally Advanced Unresectable Pancreatic Cancer". This phase I trial tests the safety and tolerability of olaparib in combination with durvalumab and radiation therapy in patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable). Olaparib is an inhibitor of PAR...
What is the current status of trial NCT05411094?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2023-05-22. Estimated completion is 2028-07-01.
What conditions does trial NCT05411094 study?
This clinical trial studies the following conditions: Stage III Pancreatic Cancer AJCC v8, Stage II Pancreatic Cancer AJCC v8, Unresectable Pancreatic Carcinoma, Locally Advanced Pancreatic Carcinoma.
What interventions are being tested in trial NCT05411094?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Durvalumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05411094?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05411094 being conducted?
This trial has 11 study locations across California, Michigan, North Carolina, Ohio, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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