Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06483555

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pancreatic Adenocarcinoma Basal Cell Neoplasm Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Metastatic Pancreatic Cancer Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Basal Cell Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location status: Recruiting

Location contact

Ashwin Somasundaram, MD

PRINCIPAL_INVESTIGATOR

Catherine A Griffin

CONTACT

[email protected]

984-974-8771

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gemcitabine

Drug

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

Other names: Gemcitabine hydrochloride, FF 10832, LY188011, C9H11F2N3O4 - HCl

Nab paclitaxel

Drug

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

Other names: Abraxane

Erlotinib

Drug

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

Other names: Tarceva

NALIRIFOX

Drug

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.

Other names: A combination of liposomal irinotecan,5 fluorouracil /leucovorin and oxaliplatin.

Folfirinox

Drug

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

Other names: It is a combination of leucovorin calcium (folinic acid), fluorouracil, irinotecan hydrochloride, and oxaliplatin

Primary outcomes

  1. Adverse Events per Common Terminology Criteria for Adverse Events (NCI-CTCAE)

    Time frame: 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.

    .

  2. Dose-limiting toxicity (DLT)

    Time frame: 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.

  3. Overall survival- classical metastatic pancreatic adenocarcinoma

    Time frame: 2 years

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

  4. Progression-free survival

    Time frame: 2 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.

Secondary outcomes

  1. 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

    The number of Adverse Events (AEs) in subjects with basal-like pancreatic carcinoma treated with low-dose erlotinib when administered with bi-weekly gemcitabine/nab-paclitaxel as defined by CTCAE v5.

  2. Overall survival in subjects with basal-like metastatic pancreatic adenocarcinoma

    Time frame: 2 years

    Overall survival in subjects with basal-like metastatic pancreatic adenocarcinoma on low-dose erlotinib when administered with bi-weekly gemcitabine/nab-paclitaxel is defined as the length of time from the start of treatment until death (basal-like arm only).

  3. The objective response in subjects with classical pancreatic adenocarcinoma

    Time frame: Up to 12 weeks

    The objective response in subjects with classical pancreatic adenocarcinoma treated with standard-of-care triplet chemotherapy (FOLFIRINOX or NALIRIFOX) as defined as complete response (CR) + partial response (PR) as determined by RECIST 1.1 criteria.

  4. 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

    The number of Adverse Events (AEs) in subjects with classical pancreas carcinoma treated with standard-of-care triplet therapy as defined by CTCAE v5.0.

  5. Progression-free survival (PFS) in subjects with classical pancreatic adenocarcinoma

    Time frame: 2 years

    Progression-free survival (PFS) after standard-of-care triplet chemotherapy (FOLFIRINOX or NALIRIFOX) in patients with classical metastatic pancreatic adenocarcinoma is defined as the length of time between the start of standard-of-care triplet therapy until progression or death.

  6. The objective response rate- basal-like pancreatic carcinoma

    Time frame: Up to 12 weeks

    The objective response rate in Stage 2 subjects with basal-like histology, treated with low-dose erlotinib at the OBD when administered with bi-weekly gemcitabine/nab-paclitaxel as defined as complete response (CR) + partial response (PR) as determined by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) 1.1 criteria. RECIST indicates if the subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine A Griffin

CONTACT

[email protected]

1 984-974-8771

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

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.

Acronym: PANGEA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 3, 2024
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.