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Study of Gemcitabine, Erlotinib, and Nab-paclitaxel for Pancreatic Cancer

This study is looking at new ways to treat advanced pancreatic cancer. Researchers want to see if adding a drug called erlotinib to standard chemotherapy (gemcitabine and nab-paclitaxel) is safe and helpful for people with a specific type of pancreatic cancer called "basal-like." Before joining, your tumor will be tested to see if it's "basal-like" or "classical." If you have basal-like cancer, you might receive gemcitabine, nab-paclitaxel, and erlotinib. The study will measure side effects and how long people live. We don't have information on the current recruitment status.

Study design
This is a Phase I/II interventional study planning to enroll 104 participants. It aims to find the safest dose of erlotinib with standard chemotherapy, and then compare that combination to standard chemotherapy alone.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Overall survival for classical metastatic pancreatic adenocarcinoma will be measured for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06483555

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
UNC Lineberger Comprehensive Cancer Center
~104 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:GemcitabineNab paclitaxelErlotinibNALIRIFOXFolfirinox

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Adverse Events per Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Measured over First day of study treatment through the 28 days after last treatment
+3 more outcomes measured

Conditions

Pancreatic Adenocarcinoma
Metastatic Pancreatic Cancer
Basal Cell Neoplasm

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NCT06483555

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ashwin Somasundaram, MD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center

Who to contact

Catherine A Griffin
[email protected]
1 984-974-8771
Email the study team

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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 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

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

What this trial measures

  • Adverse Events per Common Terminology Criteria for Adverse Events (NCI-CTCAE)First day of study treatment through the 28 days after last treatment

    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. .

  • Dose-limiting toxicity (DLT)Up to 28 days

    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.

  • Overall survival- classical metastatic pancreatic adenocarcinoma2 years

    Overall survival of subjects with classical metastatic pancreatic adenocarcinoma is defined as the length of time from the start of treatment until death.

  • Progression-free survival2 years

    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.