Recruiting
Phase 2

NALIRIFOX & GnP

Sponsor:

Northwell Health

Code:

NCT07163273

Conditions

Pancreatic Ductal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NALIRIFOX

Gemcitabine plus nab-Paclitaxel (GnP)

Study Details

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

Study ID

NCT07163273

Start date

Jun 20, 2025

Status verified date

Mar, 2026

Completion date

Jun 20, 2027

Anticipated

Primary completion date

Jun 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion:

  • >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.
  • PT/INR INR ≤ 1.5 × ULN. For subjects receiving warfarin, 2.0 -3.0, or within acceptable range considered by the investigator.
  • Women of childbearing potential must be surgically sterile or postmenopausal or must have a negative pregnancy test (serum or urine) prior to study enrolment and must use effective barrier contraception or abstinence during the treatment period. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions and therefore are not considered effective for this study. Male patients must be surgically sterile or use effective contraception or abstinence during the treatment period. The definition of effective contraception will be based on investigator discretion. Female and male patients are advised to use effective contraceptives for at least 9 months after the last treatment dose.
  • Ability to understand and willing to sign informed consent form

Exclusion:

  • 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.

Study Design

Enrollment

41 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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

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 and Locations

Central contacts

GI Trial Referral

5167348896gitrialreferral@northwell.edu

Lalta Dhanantwari, MBA

5167348896ldhanantwari@northwell.edu

Locations

Imbert Cancer Center

Recruiting

Bay Shore, New York, United States, 11706

Contacts

GI Trial Referral

516-734-8896gitrialreferral@northwell.edu

Northern Westchester Cancer Center

Recruiting

Mount Kisco, New York, United States, 10549

Contacts

GI Trial Referral

516-734-8896gitrialreferral@northwell.edu

Long Island Jewish Medical Center

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

GI Trial Referral

516-734-8896gitrialreferral@northwell.edu

Zuckerberg Cancer Center

Recruiting

New Hyde Park, New York, United States, 11042

Contacts

GI Trial Referral

516-734-8896gitrialreferral@northwell.edu

Daniel King, MD

5167348900dking14@northwell.edu

Principal Investigator:

Daniel King, MD, PhD

Manhattan Eye, Ear and Throat Hospital

Recruiting

New York, New York, United States, 10065

Contacts

GI Trial Referral

516-734-8896gitrialreferral@northwell.edu

NHPP Medical Oncology at Rego Park

Recruiting

Rego Park, New York, United States, 11374

Contacts

GI Trial Referral

516-734-8896gitrialreferral@northwell.edu

Phelps Cancer Center

Recruiting

Sleepy Hollow, New York, United States, 10591

Contacts

GI Trial Referral

516-734-8896gitrialreferral@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-03-18.