Study Details

Open

Basal-like PDAC treated with Gemcitabine, Erlotinib and nab-paclitaxel (PANGEA).

To determine the Optimal Biologic Dose (OBD) of low-dose erlotinib when administered with bi-weekly gemcitabine/nab-paclitaxel in subjects with basal-like (defined by PurIST) metastatic pancreatic adenocarcinoma in the first-line setting in Stage I, the basal-like arm.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina

What will be asked of you

Your medical history, performance status, Cancer assessment using CT or MRI scans and a blood test. Tissue biopsy, if you don't have an available biopsy the study can use. Completing questionnaires that will help the study team evaluate your health and cancer conditions. Performance status review, where you will be asked questions about how well you are feeling, and how cancer is affecting your daily life

In-person visits:
4-60

Phone or online visits:
5

Total length of participation:
Up to 5 years on treatment and up to 5 years on follow-up

Looking for Specific Volunteers

Able to participate:

Histological or cytological evidence/confirmation of metastatic pancreatic adenocarcinoma.
The subject must consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient.
No prior pancreatic focused therapy is permitted unless it was in the neoadjuvant setting
Demonstrate adequate hematological, renal, hepatic, and coagulation function as defined in the protocol.
Performance status of 0-1

Not eligible if:

Active infection requiring systemic therapy
Treatment with any investigational drug or prior cancer treatment within 28 days prior to study treatment.
Untreated HBV may be eligible for study if positive but under physicians treatment.
Subject is currently using tobacco products or vaping.
Subject is receiving any of the prohibited medications or treatments per protocol.

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Trials Office
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Ashwin Somasundaram
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Pancreatic)

IRB Number

24-0912