RecruitingInterventionalPhase 1/Phase 2

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.

NCT ID: NCT06483555Sponsor: UNC Lineberger Comprehensive Cancer CenterLast updated: 2026-04-23

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.

Arms & 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.

Outcome measures

Primary

Adverse Events per Common Terminology Criteria for Adverse Events (NCI-CTCAE)
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. .
Time frame: First day of study treatment through the 28 days after last treatment
Dose-limiting toxicity (DLT)
DLTs are defined using adverse events as at least possibly related to erlotinib administration in Phase I subjects. If an apparent DLT is clearly due to an underlying disease and is unrelated to the product infusion, then the investigator will specify that the event is not a DLT. Toxicities related to treatment and assessed Adverse Events per Common Terminology Criteria for Adverse Events (NCI-CTCAE) will be used for assessment. The safety evaluation period for dose-limiting toxicity (DLT) assessment and determination of optimal best dose (OBD) will encompass toxicities related to treatment with low-dose erlotinib when administered with bi-weekly gemcitabine/nab-paclitaxel starting on the day of treatment initiation through the end of treatment.
Time frame: Up to 28 days
Overall survival- classical metastatic pancreatic adenocarcinoma
Overall survival of subjects with classical metastatic pancreatic adenocarcinoma is defined as the length of time from the start of treatment until death.
Time frame: 2 years
Progression-free survival
Progression-free survival in subjects on low-dose erlotinib when administered with bi-weekly gemcitabine/nab-paclitaxel with basal-like metastatic pancreatic adenocarcinoma is defined as the length of time between the start of treatment until progression or death.
Time frame: 2 years

Secondary

The number of Adverse Events (AEs) in subjects with basal like pancreatic carcinoma
Time frame: First day of study treatment through the 28 days after last treatment
Overall survival in subjects with basal-like metastatic pancreatic adenocarcinoma
Time frame: 2 years
The objective response in subjects with classical pancreatic adenocarcinoma
Time frame: Up to 12 weeks
The number of Adverse Events (AEs) in subjects with classical pancreatic adenocarcinoma
Time frame: First day of study treatment through the 28 days after last treatment
Progression-free survival (PFS) in subjects with classical pancreatic adenocarcinoma
Time frame: 2 years
The objective response rate- basal-like pancreatic carcinoma
Time frame: Up to 12 weeks

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

Inclusion Criteria: * 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 Histological or cytological evidence/confirmation of unresectable, borderline resectable, or metastatic (basal-like and classical) pancreatic adenocarcinoma. * The subject must consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient. * Subjects may have received prior standard-of-care (SOC) neoadjuvant therapy and may have received up to two cycles of first-line FOLFIRINOX or NALIRIFOX. * A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study treatment have been off of corticosteroids for ≥ 2 weeks and are asymptomatic. Exclusion Criteria: * 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. * Treatment with any investigational drug or prior cancer treatment within 28 days prior to study treatment

Study locations (1)

University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

Recruiting

Catherine A Griffin · Contact

984-974-8771 catherine_griffin@med.unc.edu

Ashwin Somasundaram, MD · Principal Investigator