RecruitingPhase 1Phase 2NCT06483555

Basal-like PDAC Treated With Gemcitabine, Erlotinib, and Nab-paclitaxel

Subjects With Advanced Basal-like Pancreatic Adenocarcinoma Treated With Gemcitabine, Erlotinib and Nab-paclitaxel (PANGEA) Versus Subjects With Classical Pancreatic Adenocarcinoma Treated With Triplet Standard of Care Therapy.


Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

104 participants

Start Date

Feb 6, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This Phase I/II clinical trial is being conducted at multiple centers to find out whether adding a low dose of EGFR blocking drugs to the standard chemotherapy combination of gemcitabine and nab paclitaxel (GnP) is safe, tolerable, and helpful for people with advanced pancreatic cancer. All participants are first tested with a tool called PurIST, which classifies tumors as either "basal-like" or "classical." People with basal-like tumors will receive GnP plus erlotinib during Phase I so researchers can determine the safest and most effective dose. Once that dose is identified, the study moves to Phase II, where people with basal-like tumors will be randomly assigned to receive either GnP alone or GnP with erlotinib. Phase II may also test new drug combinations if new treatments become approved during the study period. Overall, the trial plans to include up to about 52 basal-like patients in Phase I, roughly 82 basal-like patients in Phase II, and at least 52 classical patients, with the possibility of enrolling more if needed. People whose tumors are classified as classical will continue with standard treatments recommended by their doctors or other clinical trials. Across the entire study, researchers will carefully track long-term outcomes such as overall survival, how long patients live before the cancer progresses, and how well their tumors respond to treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug chemotherapy combination — gemcitabine, erlotinib, and nab-paclitaxel — specifically in patients with "basal-like" pancreatic ductal adenocarcinoma (PDAC), a particularly aggressive subtype of pancreatic cancer identified by genetic profiling. The goal is to see if this combination works better for this specific subtype. **You may be eligible if...** - You are 18 or older - You have been diagnosed with basal-like pancreatic ductal adenocarcinoma (confirmed by molecular testing) - Your ECOG performance status is 0 or 1 (you are fully active or have minor limitations) - You have consented to provide a biopsy if archival tissue is not available - Your disease is measurable on scans **You may NOT be eligible if...** - Your disease is not measurable by standard imaging criteria - You have severe organ impairment that would make chemotherapy unsafe - You have an active unrelated cancer that could interfere with this study Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGemcitabine

1000 mg/m2, intravenously on day 1 and day 15, for subjects with basal-like cell type pancreatic carcinoma.

DRUGNab paclitaxel

125 mg/m2 intravenously on day 1 and day 15 for subjects with basal-like cell type pancreatic carcinoma.

DRUGErlotinib

50 mg per oral daily. for subjects with basal-like cell type pancreatic carcinoma.

DRUGNALIRIFOX

Subjects with classical pancreatic adenocarcinoma will receive. NALIRIFOX is liposomal irinotecan with 5-fluorouracil/leucovorin and oxaliplatin. Dosing and plan will be decided by the treating physician.

DRUGFolfirinox

Subjects with classical pancreatic adenocarcinoma will receive. Dosing and plan will be decided by the treating physician.


Locations(1)

University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

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NCT06483555


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