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Anti-metabolites
Combination Therapy 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
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Age ≥ 18 years at the time of consent
Must not have
Not having histological or cytological evidence/confirmation of metastatic pancreatic adenocarcinoma
Prior pancreatic-focused therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to find the best dose of a combination treatment for patients with an advanced form of pancreatic cancer. The study will look at the safety, effectiveness, and side effects of using a low dose
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 belowSelect...
I am fully active or can carry out light work.
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I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer is not confirmed as metastatic pancreatic adenocarcinoma.
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I have had treatment specifically for pancreatic cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 moreSecondary 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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Gemcitabine
2017
Completed Phase 3
~1920
Nab paclitaxel
2014
Completed Phase 2
~580
Erlotinib
2011
Completed Phase 4
~2290
Find a Location
Who is running the clinical trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
365 Previous Clinical Trials
92,616 Total Patients Enrolled
Ashwin Somasundaram, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
4 Previous Clinical Trials
120 Total Patients Enrolled