Status:
RECRUITING
Basal-like PDAC Treated With Gemcitabine, Erlotinib, and Nab-paclitaxel
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Conditions:
Pancreatic Adenocarcinoma
Metastatic Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
The standard of care chemotherapy for first-line advanced pancreatic adenocarcinoma is FOLFIRINOX, NALIRIFOX, or gemcitabine/nab-paclitaxel. However, multiple studies suggest that basal-like subtypes ...
Eligibility Criteria
Inclusion
- Written informed consent was obtained to participate in the study and HIPAA authorization for release of personal health information. Subjects is willing and able to comply with study procedures based on the judgment of the investigator.
- Age ≥ 18 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
- The subject must consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient.
- Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Exclusion
- Disease is not measurable according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1
- Not having histological or cytological evidence/confirmation of metastatic pancreatic adenocarcinoma.
- Prior pancreatic-focused therapy.
- Brain metastasis diagnosed within the last 4 weeks.
Key Trial Info
Start Date :
February 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06483555
Start Date
February 6 2025
End Date
August 1 2027
Last Update
April 16 2025
Active Locations (1)
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1
University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599