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Pancreatic Ductal AdenocarcinomaPhase 2NCT07163273

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

A Phase 2 study testing NALIRIFOX and Gemcitabine plus nab-Paclitaxel (GnP) in people with Pancreatic Ductal Adenocarcinoma, run by Northwell Health at 7 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Ductal Adenocarcinoma
What is being tested?
NALIRIFOX and Gemcitabine plus nab-Paclitaxel (GnP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
7 sitesUnited States
Study dates
26 Jun 2025to 20 Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >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
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

GI Trial Referral contact

5167348896

gitrialreferral@northwell.edu

Lalta Dhanantwari, MBA contact

5167348896

ldhanantwari@northwell.edu

7 sites in 1 country

United States7 sites, 7 recruiting

  • Imbert Cancer Center

    Bay Shore, New York, 11706

    GI Trial Referral, 516-734-8896, gitrialreferral@northwell.edu

    Recruiting

  • Northern Westchester Cancer Center

    Mount Kisco, New York, 10549

    GI Trial Referral, 516-734-8896, gitrialreferral@northwell.edu

    Recruiting

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

    GI Trial Referral, 516-734-8896, gitrialreferral@northwell.edu

    Recruiting

  • Zuckerberg Cancer Center

    New Hyde Park, New York, 11042

    GI Trial Referral, 516-734-8896, gitrialreferral@northwell.edu

    Daniel King, MD, 5167348900, dking14@northwell.edu

    Recruiting

  • Manhattan Eye, Ear and Throat Hospital

    New York, New York, 10065

    GI Trial Referral, 516-734-8896, gitrialreferral@northwell.edu

    Recruiting

  • NHPP Medical Oncology at Rego Park

    Rego Park, New York, 11374

    GI Trial Referral, 516-734-8896, gitrialreferral@northwell.edu

    Recruiting

  • Phelps Cancer Center

    Sleepy Hollow, New York, 10591

    GI Trial Referral, 516-734-8896, gitrialreferral@northwell.edu

    Recruiting

Other trials in United States

About this study

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.

Being tested
NALIRIFOX, Gemcitabine plus nab-Paclitaxel (GnP)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NALIRIFOXDrug

    Also called 5fu/ leucovorin / oxaliplatin / liposomal irinotecan

    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

    Also called Gemcitabine/nab-Paclitaxel

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

Study groups in NCT07163273
Study groupRoleWhat they receive
NALIRIFOXActive comparatorNALIRIFOX 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
Receives: Drug: NALIRIFOX
Gemcitabine plus nab-Paclitaxel (GnP)Active comparatorGnP consists of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2, given on Days 1, 8, and 15.
Receives: Drug: Gemcitabine plus nab-Paclitaxel (GnP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (5)

  1. Overall Response Rate

    Overall response rate, defined as the proportion of patients whose best response is partial response or complete response by RECIST v.1.1

    Measured: 24 months

  2. Disease Control Rate

    Disease control rate, defined as the proportion of patients whose best response is stable disease, partial response, or complete response, by RECIST v.1.1

    Measured: 24 months

  3. Overall Survival

    OS, defined as the time from treatment initiation to death. Patients living without disease progression will be censored at the date of last assessment

    Measured: 24 months

  4. Determine Toxicities using the NCI CTCAE v. 5.0

    AEs will be monitored, and the incidence, severity, and relationship to study drug will be reported.

    Measured: 24 months

  5. Time to Treatment Failure

    Time to treatment failure, defined as the time from treatment initiation to discontinuation of treatment, either due to progression or intolerance

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2025
  2. Study start26 Jun 2025
  3. Primary completion20 Jun 2027 (estimated)
  4. Study completion20 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07163273
Sponsor's protocol ID
24-0950
Status last verified
Sep 2026
First submitted
14 Jul 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NALIRIFOX and Gemcitabine plus nab-Paclitaxel (GnP) in people with Pancreatic Ductal Adenocarcinoma, run by Northwell Health at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact GI Trial Referral (5167348896, gitrialreferral@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine 6-month Progression Free Survival (PFS) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07163273.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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