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

NCT07163273 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 24-0950
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Determine 6-month Progression Free Survival (PFS)

  The primary endpoint is 6-month PFS rate defined as the proportion of patients alive and progression free (by RECIST v.1.1) at 6 months after treatment initiation. PFS events will be classified as either local progression, distant recurrence, secondary malignancy, or death.

  6 months

Secondary Outcomes (5)

• Overall Response Rate

  24 months

• Disease Control Rate

  24 months

• Overall Survival

  24 months

• Determine Toxicities using the NCI CTCAE v. 5.0

  24 months

• Time to Treatment Failure

  24 months

Study Arms (2)

NALIRIFOX

ACTIVE COMPARATOR

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

Drug: NALIRIFOX

Gemcitabine plus nab-Paclitaxel (GnP)

ACTIVE COMPARATOR

GnP consists of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2, given on Days 1, 8, and 15.

Drug: Gemcitabine plus nab-Paclitaxel (GnP)

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

Also known as: 5fu/ leucovorin / oxaliplatin / liposomal irinotecan

NALIRIFOX

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.

Also known as: Gemcitabine/nab-Paclitaxel

Gemcitabine plus nab-Paclitaxel (GnP)

Eligibility Criteria

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

You may qualify if:

• \>18 years of age
• Histologically proven pancreatic ductal adenocarcinoma, poorly differentiated carcinoma, or adenosquamous carcinoma
• Radiographic evidence of metastatic disease
• At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
• Metastatic relapse of previously resected pancreatic cancer is allowed provided the patient is more than 6 months from last SOC adjuvant treatment
• ECOG PS 0-1
• Laboratory assessments within 14 days as indicated below:
• Hemoglobin \> 9.0 g/dL (patients with hemoglobin \< 9 g/dL may be transfused prior to study enrollment)
• Platelet count \> 100 x 10\^9/L
• Absolute neutrophil count (ANC) \> 1.5 x 10\^9/L
• Total bilirubin \< 3 x upper limit of normal (ULN)
• Aspartate transaminase (AST) and alanine transaminase (ALT) \< 3 x ULN (if liver metastases are present, AST and ALT \< 5 x ULN is permitted.
• Creatinine ≤1.5 ULN
• Creatinine clearance \> 40 mL/min as calculated by Cockcroft-Gault formula
• APTT (aPTT) ≤ 1.5 × ULN. For subjects receiving unfractionated heparin \< 2.5 × ULN, or within acceptable range considered by the investigator.

You may not qualify if:

• A history of other disease, metabolic dysfunction, physical examination finding or clinical laboratory test result suspicious of a disease or condition which, in the opinion of the investigator, would compromise patient safety due to risk of treatment complications or could affect interpretation of the study results
• Ampullary, acinar, squamous, and neuroendocrine histology
• Presence of central nervous system metastases
• Life expectancy \< 12 weeks
• Pregnant or breastfeeding women
• Prior neuropathy \> grade 1 as per CTCAE v5
• Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
• Major surgery within 4 weeks prior to initiation of the study treatment, without full recovery
• Any past chemotherapy delivered for metastatic pancreatic cancer
• Known somatic or germline mutations in BRCA1, BRCA2, or PALB2
• Active second malignancy whose prognosis has a high likelihood of impacting survival
• Any other medical or social condition deemed by the investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results. Patients also unwilling or unable to comply with study procedures and/or study visits, including long-term follow-up for survival.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (7)

Imbert Cancer Center

Bay Shore, New York, 11706, United States

RECRUITING

Northern Westchester Cancer Center

Mount Kisco, New York, 10549, United States

RECRUITING

Long Island Jewish Medical Center

New Hyde Park, New York, 11040, United States

RECRUITING

Zuckerberg Cancer Center

New Hyde Park, New York, 11042, United States

RECRUITING

Manhattan Eye, Ear and Throat Hospital

New York, New York, 10065, United States

RECRUITING

NHPP Medical Oncology at Rego Park

Rego Park, New York, 11374, United States

RECRUITING

Phelps Cancer Center

Sleepy Hollow, New York, 10591, United States

RECRUITING

MeSH Terms

Interventions

Fluorouracil; Leucovorin; Oxaliplatin; irinotecan sucrosofate; Gemcitabine; 130-nm albumin-bound paclitaxel

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides

Central Study Contacts

GI Trial Referral

CONTACT

5167348896; gitrialreferral@northwell.edu

Lalta Dhanantwari, MBA

CONTACT

5167348896; ldhanantwari@northwell.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: September 9, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): June 20, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)