Pancreatic Adenocarcinoma > Erlotinib

Combination Therapy for Pancreatic Cancer

(PANGEA Trial)

Recruiting in Palo Alto (17 mi)

Overseen By Ashwin Somasundaram, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: UNC Lineberger Comprehensive Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I am fully active or can carry out light work.

Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information

Subject must consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient

Exclusion Criteria

I was diagnosed with brain metastasis in the last 4 weeks.

My cancer is not confirmed as metastatic pancreatic adenocarcinoma.

Disease is not measurable according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1

Participant Groups

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.

Group I: PurIST Basal Experimental Treatment 3 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 Classical Active Control 2 Interventions

Subjects will be screened using the PurIST classifier and with classical tumors will be treated per standard of care on triplet therapy.

Erlotinib is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Tarceva for:

• Non-small cell lung cancer
• Pancreatic cancer

🇺🇸 Approved in United States as Tarceva for:

• Non-small cell lung cancer
• Pancreatic cancer

🇨🇦 Approved in Canada as Tarceva for:

• Non-small cell lung cancer
• Pancreatic cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center Chapel Hill, NC

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center Lead Sponsor

References