Monthly Alternating NALIRIFOX and GnP in the First-Line Setting for Metastatic Pancreatic Ductal Adenocarcinoma

Part of paid clinical trials in Bay Shore, New York.

Sponsor
Northwell Health
Study ID
NCT07163273
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • NALIRIFOX — DRUG
    NALIRIFOX consists of 5-FU 2400 mg/m2 over 46 hours, liposomal irinotecan 50 mg/m2, and oxaliplatin 60 mg/m2, which would be given on Day 1 and Day 15
  • Gemcitabine plus nab-Paclitaxel (GnP) — DRUG
    GnP consists of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2, given on Days 1, 8, and 15.

Study Details

A prospective, interventional, single-center, single-arm, open-label, phase II study for patients with metastatic pancreatic cancer. The intervention consists of monthly alternating standard chemotherapy regimens-NALIRIFOX and GnP. The hypothesis is that induction therapy with alternating NALIRIFOX and GnP has better efficacy compared to historical observation.

Key Dates

Start date
Jun 20, 2025
Status verified
Mar 2026
Primary completion
Jun 20, 2027
Completion
Jun 20, 2027

Study Design

Enrollment
41 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: NALIRIFOX
    NALIRIFOX consists of 5-FU 2400 mg/m2 over 46 hours, liposomal irinotecan 50 mg/m2, and oxaliplatin 60 mg/m2, which would be given on Day 1 and Day 15
  • Active Comparator: Gemcitabine plus nab-Paclitaxel (GnP)
    GnP consists of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2, given on Days 1, 8, and 15.

Primary Outcome Measure

Determine 6-month Progression Free Survival (PFS) [ Time Frame: 6 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Imbert Cancer CenterBay ShoreNew York11706
GI Trial Referral
[email protected]
516-734-8896
Northern Westchester Cancer CenterMount KiscoNew York10549
GI Trial Referral
[email protected]
516-734-8896
Long Island Jewish Medical CenterNew Hyde ParkNew York11040
GI Trial Referral
[email protected]
516-734-8896
Zuckerberg Cancer CenterNew Hyde ParkNew York11042
GI Trial Referral
[email protected]
516-734-8896
Daniel King, MD
[email protected]
5167348900
Daniel King, MD, PhD (PRINCIPAL_INVESTIGATOR)
Manhattan Eye, Ear and Throat HospitalNew YorkNew York10065
GI Trial Referral
[email protected]
516-734-8896
NHPP Medical Oncology at Rego ParkRego ParkNew York11374
GI Trial Referral
[email protected]
516-734-8896
Phelps Cancer CenterSleepy HollowNew York10591
GI Trial Referral
[email protected]
516-734-8896

Find similar trials in Bay Shore, NY

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Imbert Cancer Center· Bay Shore, NYNorthern Westchester Cancer Center· Mount Kisco, NYLong Island Jewish Medical Center· New Hyde Park, NYZuckerberg Cancer Center· New Hyde Park, NYManhattan Eye, Ear and Throat Hospital· New York, NYNHPP Medical Oncology at Rego Park· Rego Park, NY

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