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Pancreatic CancerPhase 1/2NASOXNCT04662112

Liposomal Irinotecan, S-1, and Oxaliplatin in Advanced Pancreatic Adenocarcinoma

A Phase 1/2 study testing NASOX in people with Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, run by Asan Medical Center at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In present study, the investigators evaluate the safety and efficacy of OIS-derived NASOX regimen (nal-IRI, S-1, oxaliplatin) in advanced pancreatic cancer. NASOX regimen contains nal-IRI, which has recently been proven effective in pancreatic cancer. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
NASOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesSouth Korea
Study dates
15 Jun 2021to 30 Dec 2024
Phase
Phase 1/2
Are there results?
None posted in the registry

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

Who may be able to join

  • Age 19 years and older
  • Histologically or cytologically confirmed, measurable pancreatic adenocarcinoma
  • Treatment naïve locally advanced or metastatic disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate bone marrow function as defined by platelets ≥ 100 x 109/L , neutrophils ≥ 1.5 x 109/L and hemoglobin > 9 g/dL; transfusion is allowed, provided interval is ≥ 7 days prior to screening
  • Adequate renal function, with serum creatinine < 1.5 x upper limit of normal (ULN). And calculated clearance ≥ 50 mL/min/1.73m2 for patients with serum creatinine levels above or below the institutional normal value. Actual body weight should be used for calculating creatinine clearance using the Cockcroft-Gault Equation (CreatClear = Sex x ((140 - Age) / (SerumCreat)) x (Weight / 72); for patients with body mass index (BMI) >30 kg/m2, lean body weight should be used instead
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  • Adequate hepatic function with serum total bilirubin ≤ 2 x ULN (biliary drainage is allowed for biliary obstruction), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN is acceptable if liver metastases are present)
  • History of any second malignancy in the last 3 years; patients with prior history of in-situ cancer or basal or squamous cell skin cancer are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 3 years.
  • Female patients must be either surgically sterile or postmenopausal, or if of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrolment and agree to use effective barrier contraception during the period of therapy and for one month after the last dose.
  • Written, informed consent to the study

Who cannot join

  • Endocrine or acinar pancreatic carcinoma
  • Uncontrolled CNS metastases (Note: Patients who require steroids should be on a stable or decreasing dose to be eligible)
  • Medical or psychiatric conditions that compromise the patient's ability to give informed consent or to complete the protocol or a history of non-compliance
  • Obstruction of gastrointestinal tract
  • Active gastrointestinal bleeding
  • Myocardial infarction within 6 months prior to the study medication, and other clinically significant heart disease (e.g., unstable angina, congestive heart failure or uncontrolled hypertension)
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  • Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardise compliance with the protocol
  • Active infection or an unexplained fever > 38.5°C during screening visits or on the first scheduled day of dosing (at the discretion of the investigator, patients with tumor fever may be enrolled), which in the investigator's opinion might compromise the patient's participation in the trial or affect the study outcome
  • Use of strong CYP3A4 inhibitors or inducers, or strong UGT1A1 inhibitors (patients are ineligible if unable to discontinue the use of strong CYP3A4 or UGT1A1 inhibitors at least 1 week or strong CYP3A4 inducers at least 2 weeks prior to receiving first dose of irinotecan liposome injection),
  • presence of any contraindications for irinotecan, nal-IRI, S1 and Oxaliplatin
  • Female patients who are pregnant (positive pregnancy test at screening) or breast-feeding

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Hallym University Medical Center

    Anyang-si, Gyeonggi-do, 05505

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

About this study

Official title: Multicenter Phase I/IIa Study of NASOX (Nal-IRI + S-1 + Oxaliplatin) as First-line Treatment for Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma

In present study, the investigators evaluate the safety and efficacy of OIS-derived NASOX regimen (nal-IRI, S-1, oxaliplatin) in advanced pancreatic cancer. NASOX regimen contains nal-IRI, which has recently been proven effective in pancreatic cancer.

Read the detailed description

Pancreatic adenocarcinoma is the seventh leading cause of cancer-related mortality worldwide, and it carries dismal prognosis with a 5-year survival rate of 1-2%. The pivotal ACCORD11 trial, FOLFIRINOX (oxaliplatin, irinotecan, 5-FU and leucovorin) has become the standard of care for patients with locally advanced or metastatic pancreatic adenocarcinoma. In daily practice, modified version of FOLFIRINOX (mFOLFIRINOX) with reduced dose of irinotecan to 150 mg/m2 and omission of bolus 5-FU has been widely used to enhance the dose intensity and safety profiles.

Despite of proven efficacy of mFOLFIRINOX in locally advanced or metastatic pancreatic cancer, further improvement in the efficacy outcomes are needed, considering that median overall survival of metastatic pancreatic cancer patients treated with FOLFIRINOX in the phase 3 trial was less than 1 year. Considering that mFOLFIRINOX often require placement of central catheterization or repeated hospitalization for continuous 5-FU infusion, novel regimens improving mFOLFIRINOX in the viewpoint of patient's quality of life is also needed. This may enhance the patient's compliance on the treatment and maximize the clinical outcomes.

Liposomal irinotecan (nal-IRI) is the novel agent enhancing the drug delivery of irinotecan and approved for the management of gemcitabine-progressed metastatic pancreatic cancer patients. Considering the hostile tumor microenvironment of pancreatic adenocarcinoma, nal-IRI may have enhanced anti-tumor activity compared to conventional irinotecan, although there are no head-to-head comparison clinical trial data, yet.

Investigators previously developed oral fluoropyrimidine-based triplet regimen (oxaliplatin, irinotecan and S-1) and investigated in 32 patients with advanced biliary tract cancer. This regimen was well tolerated and showed favorable efficacy outcome as first-line therapy with overall response rate of 50%.

In present study, investigators evaluate the safety and efficacy of OIS-derived NASOX regimen (nal-IRI, S-1, oxaliplatin) in advanced pancreatic cancer. NASOX regimen contains nal-IRI, which has recently been proven effective in pancreatic cancer. If NASOX, which is more convenient than FOLFIRINOX, proves its safety and effectiveness, it may provide an attractive alternative for pancreatic cancer patients.

Being tested
NASOX
Keywords
Pancreatic adenocarcinoma, Liposomal irinotecan, S-1, Oxaliplatin
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • NASOXDrug

    Oxalipatin 60 mg/m2 IV (2 h infusion) on Day 1, every 2 weeks Nal-IRI 50-60 mg/m2 IV (FBE, 90 min infusion) on Day 1, every 2 weeks S-1 40mg/m2 oral twice daily on Day 1-7, every 2 weeks

Study groups in NCT04662112
Study groupRoleWhat they receive
NASOXExperimentalLiposomal irinotecan+S-1+oxaliplatin
Receives: Drug: NASOX

What is being measured

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

  1. Dose limiting toxicity

    Measured: 3 weeks

  2. Objective response rates

    Proportion of patients with complete and partial responses defined by RECIST version 1.1

    Measured: 6 months

Secondary outcomes (3)

  1. Overall Survival

    Time between study treatment and death

    Measured: 1 year

  2. Progression-free survival

    Time between study treatment and tumor progression, or death

    Measured: 1 year

  3. Adverse events

    Toxicity defined by Common Terminology Criteria version 5.0

    Measured: 1 year

Timeline

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

  1. First posted10 Dec 2020
  2. Study start15 Jun 2021
  3. Primary completion30 Oct 2023
  4. Study completion30 Dec 2024

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04662112
Sponsor's protocol ID
NASOX
Acronym
NASOX
Status last verified
Jan 2025
First submitted
4 Dec 2020
Last updated
28 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.

    PubMed 21561347

  • Wainberg Z, Boland P, Lieu C, Dayyani F, Macarulla T, Zhang B, Belanger B, Moore Y, Wang T, Maxwell F, Dean A (2019) A phase 1/2, open-label, dose-expansion study of liposomal irinotecan (nal-IRI) plus 5-fluorouracil/leucovorin (5-FU/LV) and oxaliplatin (OX) in patients with previously untreated metastatic pancreatic cancer. Ann Oncol 30 Suppl 4: iv123

  • Yoo C, Han B, Kim HS, Kim KP, Kim D, Jeong JH, Lee JL, Kim TW, Kim JH, Choi DR, Ha HI, Seo J, Chang HM, Ryoo BY, Zang DY. Multicenter Phase II Study of Oxaliplatin, Irinotecan, and S-1 as First-line Treatment for Patients with Recurrent or Metastatic Biliary Tract Cancer. Cancer Res Treat. 2018 Oct;50(4):1324-1330. doi: 10.4143/crt.2017.526. Epub 2018 Jan 8.

    PubMed 29334603

  • Wang-Gillam A, Li CP, Bodoky G, Dean A, Shan YS, Jameson G, Macarulla T, Lee KH, Cunningham D, Blanc JF, Hubner RA, Chiu CF, Schwartsmann G, Siveke JT, Braiteh F, Moyo V, Belanger B, Dhindsa N, Bayever E, Von Hoff DD, Chen LT; NAPOLI-1 Study Group. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016 Feb 6;387(10018):545-557. doi: 10.1016/S0140-6736(15)00986-1. Epub 2015 Nov 29.

    PubMed 26615328

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing NASOX in people with Pancreatic Cancer and Pancreatic Ductal Adenocarcinoma, run by Asan Medical Center at 2 sites in South Korea.

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 10 inclusion and 11 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: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 NCT04662112, which also lists 4 linked publications.

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 28 Jan 2025.

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