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NCT04825288 · ClinicalTrials.gov registry record · Phase 1
XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer
A Phase 1 study of Pancreatic Cancer, sponsored by XBiotech.
- Active
- Registry status
- Phase 1
- Development phase
- 76
- Enrollment target
- 20
- Study locations
NCT04825288: Active Phase 1 study of Pancreatic Cancer, sponsored by XBiotech.
NCT04825288 is a Phase 1 study of Pancreatic Cancer that is active but no longer recruiting, run by XBiotech. The registered enrollment target is 76 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04825288, a Phase 1 study of Pancreatic Cancer, is active but no longer recruiting, sponsored by XBiotech.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 76 participants
- Enrollment target
- 20
- Study locations
Study Summary
This trial will include 2 portions (phase 1 and phase 2). The first portion will be a Phase I, open label, dose escalation study to establish the maximum tolerated dose (MTD) of XB2001 as measured by Dose-Limiting Toxicity (DLT), in combination with ONIVYDE + LV + 5-FU chemotherapy regimen in patients with advanced pancreatic cancer and to determine the recommended dose for the subsequent Phase 2 study. The phase 2 portion will be implemented with the maximum established tolerated dose (MTD) of XB2001. The target enrollment in the phase 2 portion is 60 patients which will be randomized on a 1:1 basis to XB2001 plus ONIVYDE + LV + 5-FU (Arm 1) or placebo plus ONIVYDE + LV + 5-FU (Arm 2).
Primary Outcome
The primary objective of the Phase I portion is to identify the MTD of XB2001 when administered in combination with ONIVYDE + LV + 5-FU. The MTD is defined as the highest dose level at which no more than one out of six subjects experience a DLT. If two or more subjects in a cohort of six experience a DLT, the MTD is considered exceeded, and the previous lower dose level will be identified as the MTD. If no DLTs are observed at the highest dose level studied, that dose will be used for Phase II.
Conditions Studied
Interventions
- BIOLOGICAL XB2001 or Placebo
Study Locations (20)
California
- Disney Family Cancer Center at Providence St. Joseph Medical Center - Burbank
- TOI Clinical Research - Cerritos
- Providence St. Joseph Heritage - Fullerton, CA - Fullerton
- Hoag Memorial Hospital Presbyterian - Newport Beach
Florida
- Sarah Cannon - Florida Cancer Specialists - Lake Mary
- Mt. Sinai Comprehensive Cancer Center - Miami Beach
- Sarasota Memorial Hospital - Sarasota
Michigan
- Barbara Ann Karmanos Cancer Institute - Detroit
- Revive Research - Farmington Hills - Farmington Hills
- Revive Research - Sterling Heights - Sterling Heights
New York
- Stony Brook Cancer Center - Stony Brook
- Montefiore Einstein Medical Center - The Bronx
Arizona
- Arizona Oncology Associates - Tucson
Colorado
- Grand Valley Oncology - Grand Junction
Indiana
- Goshen Center for Cancer Care - Goshen
Kansas
- Alliance for Multispecialty Research, LLC - Merriam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2021-05-27 |
| Est. Completion | 2025-06-10 |
| Phase | Phase 1 |
What the registry record for NCT04825288 still lists
NCT04825288 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Pancreatic Cancer appearing as the primary indexed condition, and to 1 intervention - of which XB2001 or Placebo is the first listed.
NCT04825288 names 20 study sites across 12 states, led by California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT04825288 about?
NCT04825288 is a clinical study titled "XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer". This trial will include 2 portions (phase 1 and phase 2). The first portion will be a Phase I, open label, dose escalation study to establish the maximum tolerated dose (MTD) of XB2001 as measured by Dose-Limiting Toxicity (DLT), in combination with ONIVYDE + LV + 5-FU chemotherapy regimen in patie...
What is the current status of trial NCT04825288?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2021-05-27. Estimated completion is 2025-06-10.
What conditions does trial NCT04825288 study?
This clinical trial studies the following conditions: Pancreatic Cancer.
What interventions are being tested in trial NCT04825288?
The interventions under investigation include: XB2001 or Placebo (BIOLOGICAL).
Who is sponsoring clinical trial NCT04825288?
This trial is sponsored by XBiotech, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04825288 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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