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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT06483555
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gemcitabine — DRUG
    1000 mg/m2, intravenously on day 1 and day 15, for subjects with basal-like cell type pancreatic carcinoma.
  • Nab paclitaxel — DRUG
    125 mg/m2 intravenously on day 1 and day 15 for subjects with basal-like cell type pancreatic carcinoma.
  • Erlotinib — DRUG
    50 mg per oral daily. for subjects with basal-like cell type pancreatic carcinoma.
  • 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.
  • Folfirinox — DRUG
    Subjects with classical pancreatic adenocarcinoma will receive. Dosing and plan will be decided by the treating physician.

Study Details

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.

Key Dates

Start date
Feb 6, 2025
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
104 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PurIST Basal
    Subjects will be screened using the PurIST classifier and "basal-like" tumors will be assigned combination therapy with GnP and erlotinib.
  • Active Comparator: PurIST Classical
    Subjects will be screened using the PurIST classifier and with classical tumors will be treated per standard of care on triplet therapy.

Primary Outcome Measure

Adverse Events per Common Terminology Criteria for Adverse Events (NCI-CTCAE) [ Time Frame: First day of study treatment through the 28 days after last treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599
Catherine A Griffin
[email protected]
984-974-8771
Ashwin Somasundaram, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
University of North Carolina at Chapel Hill Lineberger Comprehensive Cancer Center· Chapel Hill, NC

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