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

NCT06483555 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: LCCC2220-DCT
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase I/II clinical trial is being conducted at multiple centers to find out whether adding a low dose of EGFR blocking drugs to the standard chemotherapy combination of gemcitabine and nab paclitaxel (GnP) is safe, tolerable, and helpful for people with advanced pancreatic cancer. All participants are first tested with a tool called PurIST, which classifies tumors as either "basal-like" or "classical." People with basal-like tumors will receive GnP plus erlotinib during Phase I so researchers can determine the safest and most effective dose. Once that dose is identified, the study moves to Phase II, where people with basal-like tumors will be randomly assigned to receive either GnP alone or GnP with erlotinib. Phase II may also test new drug combinations if new treatments become approved during the study period. Overall, the trial plans to include up to about 52 basal-like patients in Phase I, roughly 82 basal-like patients in Phase II, and at least 52 classical patients, with the possibility of enrolling more if needed. People whose tumors are classified as classical will continue with standard treatments recommended by their doctors or other clinical trials. Across the entire study, researchers will carefully track long-term outcomes such as overall survival, how long patients live before the cancer progresses, and how well their tumors respond to treatment.

Conditions

Pancreatic Adenocarcinoma; Metastatic Pancreatic Cancer; Basal Cell Neoplasm

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Adverse Events per Common Terminology Criteria for Adverse Events (NCI-CTCAE)

  Adverse Events (AEs) will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, in Phase I subjects with basal-like settings. The number of participants with adverse events (AE) will be reported. .

  First day of study treatment through the 28 days after last treatment

• Dose-limiting toxicity (DLT)

  DLTs are defined using adverse events as at least possibly related to erlotinib administration in Phase I subjects. If an apparent DLT is clearly due to an underlying disease and is unrelated to the product infusion, then the investigator will specify that the event is not a DLT. Toxicities related to treatment and assessed Adverse Events per Common Terminology Criteria for Adverse Events (NCI-CTCAE) will be used for assessment. The safety evaluation period for dose-limiting toxicity (DLT) assessment and determination of optimal best dose (OBD) will encompass toxicities related to treatment with low-dose erlotinib when administered with bi-weekly gemcitabine/nab-paclitaxel starting on the day of treatment initiation through the end of treatment.

  Up to 28 days

• Overall survival- classical metastatic pancreatic adenocarcinoma

  Overall survival of subjects with classical metastatic pancreatic adenocarcinoma is defined as the length of time from the start of treatment until death.

  2 years

• Progression-free survival

  Progression-free survival in subjects on low-dose erlotinib when administered with bi-weekly gemcitabine/nab-paclitaxel with basal-like metastatic pancreatic adenocarcinoma is defined as the length of time between the start of treatment until progression or death.

  2 years

Secondary Outcomes (6)

• The number of Adverse Events (AEs) in subjects with basal like pancreatic carcinoma

  First day of study treatment through the 28 days after last treatment

• Overall survival in subjects with basal-like metastatic pancreatic adenocarcinoma

  2 years

• The objective response in subjects with classical pancreatic adenocarcinoma

  Up to 12 weeks

• The number of Adverse Events (AEs) in subjects with classical pancreatic adenocarcinoma

  First day of study treatment through the 28 days after last treatment

• Progression-free survival (PFS) in subjects with classical pancreatic adenocarcinoma

  2 years

Study Arms (2)

PurIST Basal

EXPERIMENTAL

Subjects will be screened using the PurIST classifier and "basal-like" tumors will be assigned combination therapy with GnP and erlotinib.

Drug: Gemcitabine; Drug: Nab paclitaxel; Drug: Erlotinib

PurIST Classical

ACTIVE COMPARATOR

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

Drug: NALIRIFOX; Drug: Folfirinox

Interventions

Nab paclitaxel DRUG

125 mg/m2 intravenously on day 1 and day 15 for subjects with basal-like cell type pancreatic carcinoma.

Also known as: Abraxane

PurIST Basal

Gemcitabine DRUG

1000 mg/m2, intravenously on day 1 and day 15, for subjects with basal-like cell type pancreatic carcinoma.

Also known as: Gemcitabine hydrochloride, FF 10832, LY188011, C9H11F2N3O4 - HCl

PurIST Basal

Erlotinib DRUG

50 mg per oral daily. for subjects with basal-like cell type pancreatic carcinoma.

Also known as: Tarceva

PurIST Basal

NALIRIFOX DRUG

Subjects with classical pancreatic adenocarcinoma will receive. NALIRIFOX is liposomal irinotecan with 5-fluorouracil/leucovorin and oxaliplatin. Dosing and plan will be decided by the treating physician.

Also known as: A combination of liposomal irinotecan,5 fluorouracil /leucovorin and oxaliplatin.

PurIST Classical

Folfirinox DRUG

Subjects with classical pancreatic adenocarcinoma will receive. Dosing and plan will be decided by the treating physician.

Also known as: It is a combination of leucovorin calcium (folinic acid), fluorouracil, irinotecan hydrochloride, and oxaliplatin

PurIST Classical

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Histological or cytological evidence/confirmation of unresectable, borderline resectable, or metastatic (basal-like and classical) pancreatic adenocarcinoma.
• The subject must consent to a mandatory pre-study biopsy if archival tissue is not available or sufficient.
• Subjects may have received prior standard-of-care (SOC) neoadjuvant therapy and may have received up to two cycles of first-line FOLFIRINOX or NALIRIFOX.
• A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study treatment have been off of corticosteroids for ≥ 2 weeks and are asymptomatic.

You may not qualify if:

• Disease is not measurable according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1
• Not having histological or cytological evidence/confirmation of metastatic pancreatic adenocarcinoma.
• Treatment with any investigational drug or prior cancer treatment within 28 days prior to study treatment

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms, Basal Cell

Interventions

Gemcitabine; Taxes; Albumin-Bound Paclitaxel; Erlotinib Hydrochloride; Leucovorin; Oxaliplatin; folfirinox; Fluorouracil; Irinotecan

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Uracil; Pyrimidinones; Camptothecin; Alkaloids

Study Officials

• Ashwin Somasundaram, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine A Griffin

CONTACT

1 984-974-8771; catherine_griffin@med.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a two-stage U-BOIN design

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 3, 2024
• Study Start: February 6, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)