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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: Recruiting Phase 1 study of Stage III Pancreatic Cancer AJCC v8 and Stage II Pancreatic Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The numbers of subjects treated at each dose level and DLT incidence in both components will be summarized. Will report the estimate probability of DLT with 95% Bayesian Credible Intervals for each dose level as estimated by the TiTE-CRM algorithm at the completion of the phase IB Part 2.
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 |
What NCT05411094 shows while recruiting
NCT05411094 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 23 other Stage III Pancreatic Cancer AJCC v8 trials with a reported enrollment target (70% lower).
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 lists 11 locations in 6 states (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.
Learn More About Clinical Trials
Similar trials for Stage III 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 NCT05411094's enrollment target sits among peer trials
18 21st of 23 higher than 3 of 23 other Stage III Pancreatic Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III 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.
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