RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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, and tolerability, as well as preliminary estimates of anti-tumor effects of low-dose epidermal growth factor receptor EGFR inhibitors in combination with bi-weekly gemcitabine/nab-paclitaxel (GnP) will be examined in subjects with advanced basal-like pancreatic adenocarcinoma. The Purity Independent Subtyping of Tumors (PurIST) will determine the type of cancer either "basal type" or "classical". If cancer subtype-based first-line chemotherapy in combination with erlotinib will be safe and tolerable in subjects with advanced unresectable or metastatic pancreatic adenocarcinoma of the basal-like subtype as defined by PurIST, as well as provide a preliminary assessment of treatment response in basal-like subjects. This study will also follow a subset of subjects with classical subtypes that are treated per standard of care on oxaliplatin-based triplet chemotherapy.

Official 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.

Quick Facts

Study Start:2025-02-06
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06483555

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Age ≥ 18 years at the time of consent.
  3. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
  4. * The subject must consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient.
  5. * 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.
  1. * Disease is not measurable according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1
  2. * Not having histological or cytological evidence/confirmation of metastatic pancreatic adenocarcinoma.
  3. * Prior pancreatic-focused therapy.
  4. * Brain metastasis diagnosed within the last 4 weeks.

Contacts and Locations

Study Contact

Catherine A Griffin
CONTACT
1 984-974-8771
catherine_griffin@med.unc.edu

Principal Investigator

Ashwin Somasundaram, MD
PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center

Study Locations (Sites)

University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-06
Study Completion Date2027-08

Study Record Updates

Study Start Date2025-02-06
Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

  • safety
  • tolerability
  • efficacy
  • EGFR inhibitors
  • gemcitabine
  • nab-paclitaxel

Additional Relevant MeSH Terms

  • Pancreatic Adenocarcinoma
  • Metastatic Pancreatic Cancer
  • Basal Cell Neoplasm