← Back to Search

Anti-metabolites

PurIST Basal for Pancreatic Cancer (PANGEA Trial)

Phase 1 & 2
Waitlist Available
Led By Ashwin Somasundaram, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

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.

Who is the study for?
This trial is for adults with advanced basal-like subtype pancreatic adenocarcinoma that cannot be surgically removed or has spread. Participants must have their cancer type confirmed as 'basal type' by the PurIST test and should not have had prior chemotherapy for metastatic disease.
What is being tested?
The study tests a combination of low-dose EGFR inhibitors with bi-weekly gemcitabine/nab-paclitaxel to determine safety, tolerability, and preliminary anti-tumor effects in patients with basal-like pancreatic adenocarcinoma. It also observes subjects with classical subtypes receiving standard oxaliplatin-based chemotherapy.
What are the potential side effects?
Possible side effects include reactions to medication infusions, skin issues due to EGFR inhibitors, fatigue, nausea from chemotherapy drugs like gemcitabine and nab-paclitaxel, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events per Common Terminology Criteria for Adverse Events (NCI-CTCAE)
Dose-limiting toxicity (DLT)
Overall survival- classical metastatic pancreatic adenocarcinoma
+1 more
Secondary study objectives
Overall survival in subjects with basal-like metastatic pancreatic adenocarcinoma
Progression-free survival
Progression-free survival (PFS) in subjects with classical pancreatic adenocarcinoma
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PurIST BasalExperimental Treatment3 Interventions
Subjects will be screened using the PurIST classifier and "basal-like" tumors will be assigned combination therapy with GnP and erlotinib.
Group II: PurIST ClassicalActive Control2 Interventions
Subjects will be screened using the PurIST classifier and with classical tumors will be treated per standard of care on triplet therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nab paclitaxel
2014
Completed Phase 2
~140
Gemcitabine
2017
Completed Phase 3
~2070
Erlotinib
2011
Completed Phase 4
~2290

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
90,388 Total Patients Enrolled
Ashwin Somasundaram, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
4 Previous Clinical Trials
120 Total Patients Enrolled
~69 spots leftby Aug 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top