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NCT06483555 · ClinicalTrials.gov registry record · Phase 1
Basal-like PDAC Treated With Gemcitabine, Erlotinib, and Nab-paclitaxel
A Phase 1 study of Pancreatic Adenocarcinoma and Metastatic Pancreatic Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 104
- Enrollment target
- 1
- Study location
NCT06483555: Recruiting Phase 1 study of Pancreatic Adenocarcinoma and Metastatic Pancreatic Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT06483555 is a Phase 1 study of Pancreatic Adenocarcinoma and Metastatic Pancreatic Cancer that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 104 participants, below the 99,464-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06483555, a Phase 1 study of Pancreatic Adenocarcinoma and Metastatic Pancreatic Cancer, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 104 participants
- Enrollment target
- 1
- Study location
Study Summary
This study explores the best dose of the combination treatment for subjects with advanced unresectable or metastatic basal-like subtype pancreatic adenocarcinoma. For that reason, the safety, efficacy, and tolerability, as well as preliminary estimates of anti-tumor effects of low-dose epidermal growth factor receptor EGFR inhibitors in combination with bi-weekly gemcitabine/nab-paclitaxel (GnP) will be examined in subjects with advanced basal-like pancreatic adenocarcinoma. The Purity Independent Subtyping of Tumors (PurIST) will determine the type of cancer either "basal type" or "classical". If cancer subtype-based first-line chemotherapy in combination with erlotinib will be safe and tolerable in subjects with advanced unresectable or metastatic pancreatic adenocarcinoma of the basal-like subtype as defined by PurIST, as well as provide a preliminary assessment of treatment response in basal-like subjects. This study will also follow a subset of subjects with classical subtypes that are treated per standard of care on oxaliplatin-based triplet chemotherapy.
Primary Outcome
Adverse Events (AEs) will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, in Phase I subjects with basal-like settings. The number of participants with adverse events (AE) will be reported. .
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG Nab paclitaxel
- DRUG NALIRIFOX
- DRUG Erlotinib
- DRUG Folfirinox
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2025-02-06 |
| Est. Completion | 2027-08 |
| Phase | Phase 1 |
What NCT06483555 shows while recruiting
NCT06483555 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 99,464-participant average among 62 other Pancreatic Adenocarcinoma trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Pancreatic Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Gemcitabine is the first listed.
NCT06483555 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06483555 about?
NCT06483555 is a clinical study titled "Basal-like PDAC Treated With Gemcitabine, Erlotinib, and Nab-paclitaxel". This study explores the best dose of the combination treatment for subjects with advanced unresectable or metastatic basal-like subtype pancreatic adenocarcinoma. For that reason, the safety, efficacy, and tolerability, as well as preliminary estimates of anti-tumor effects of low-dose epidermal gro...
What is the current status of trial NCT06483555?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 104 participants. The study started on 2025-02-06. Estimated completion is 2027-08.
What conditions does trial NCT06483555 study?
This clinical trial studies the following conditions: Pancreatic Adenocarcinoma, Metastatic Pancreatic Cancer, Basal Cell Neoplasm.
What interventions are being tested in trial NCT06483555?
The interventions under investigation include: Gemcitabine (DRUG), Nab paclitaxel (DRUG), NALIRIFOX (DRUG), Erlotinib (DRUG), Folfirinox (DRUG).
Who is sponsoring clinical trial NCT06483555?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06483555 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06483555's enrollment target sits among peer trials
104 23rd of 62 higher than 40 of 62 other Pancreatic Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Adenocarcinoma 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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