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AzTrials

Pancreatic CancerPhase 2NaliCapNCT04371224

NaliCap (Irinotecan Liposome (Nal-IRI)/Capecitabine) vs. NAPOLI (Nal-IRI/5-FU/LV) ) in Advanced Pancreatic Cancer

A Phase 2 study testing Irinotecan Liposomal Injection [Onivyde], Capecitabine and 5-fluorouracil in people with Pancreatic Cancer, run by Seoul National University Hospital at 2 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an open label, randomized phase 2 study of NaliCap (irinotecan liposome/Capecitabine) compared to NAPOLI (irinotecan liposome/5-FU/LV) in gemcitabine-pretreated advanced pancreatic cancer patients. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Irinotecan Liposomal Injection [Onivyde], Capecitabine and 5-fluorouracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesSouth Korea
Study dates
23 Jun 2020to 31 Dec 2025
Phase
Phase 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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Age>20 years at time of study entry
  • Histologically confirmed pancreatic ductal adenocarcinoma
  • Advanced stage (unresectable, recurrent)
  • Gemcitabine-pretreated for advanced pancreatic cancer
  • Eastern Cooperative Oncology Group(ECOG) performance status 0, 1
Show all 9Show fewer
  • Adequate organ function
  • Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects.
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.

Who cannot join

  • Participation in another clinical study with an investigational product (IP) during the last 3 weeks
  • Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
  • Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 28 days prior to the first dose of study drug
  • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
  • Known brain metastasis or spinal cord compression.
  • History of allogenic organ transplantation
Show all 12Show fewer
  • Cardiac event during past 6 months
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
  • Active infection including tuberculosis (TB) (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (known positive hepatitis B virus (HBV) surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc (hepatitis B core antigen)] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Female subjects who are pregnant or breastfeeding or male or female subjects of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of IP.
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.

Trial locations and contacts

2 sites in 1 country.

Do-Youn Oh, M.D., PhD. contact

+82-2-2072-0701

ohdoyoun@snu.ac.kr

South Korea2 sites, 2 recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

    Jin Won Kim, MD, 82 31 787 7053, jwkim@snubh.org

    Kim

    Recruiting

  • Seoul National University Hospital

    Seoul, 110-744

    Do-Youn Oh, MD, +82-2-2072-0701, ohdoyoun@snu.ac.kr

    Recruiting

Other trials in South Korea

About this study

Official title: Randomized Phase II Study of NaliCap (Irinotecan Liposome/Capecitabine) Compared to NAPOLI (Irinotecan Liposome/5-fluorouracil/Leucovorin) in Gemcitabine-pretreated Advanced Pancreatic Cancer

This is an open label, randomized phase 2 study of NaliCap (irinotecan liposome/Capecitabine) compared to NAPOLI (irinotecan liposome/5-FU/LV) in gemcitabine-pretreated advanced pancreatic cancer patients.

Read the detailed description
  • At the time of initial diagnosis of pancreatic cancer, resectable pancreatic cancer is around 20%, locally-advanced pancreatic cancer is around 25-30%, and the remaining is metastatic pancreatic cancer.
  • In metastatic pancreatic cancer, Gemcitabine/Abraxane or FOLFIRINOX 5-fluorouracil/leucovorin/irinotecan/oxaliplatin (FOLFIRINOX) is most commonly used regimen as a palliative 1st-line chemotherapy. In gemcitabine-pretreated pancreatic cancer, irinotecan liposome(nal-IRI)/5-fluorouracil(5FU)/leucovorin(LV)(NAPOLI regimen) improved overall survival of patients compared to 5FU/LV. Now, NAPOLI is standard of care in gemcitabine-pretreated pancreatic cancer.
  • Oral 5-FU such as TS-1 is used in gemcitabine pretreated pancreatic cancer patients or 1st-line treatment in gemcitabine-intolerable patients.
  • Capecitabine is oral 5-FU, which is commonly used in GI cancers, usually replacing intravenous infusion of 5-FU. It improves patient's convenience not requiring vascular access or hospital admission.
  • In NAPOLI regimen, iv 5-FU/LV could be replaced with capecitabine. So far, nal-IRI/Capecitabine combination has not yet been tested.
  • Based on these rationale, we plan to conduct the open-label, randomized phase 2 study to assess the safety and efficacy of NaliCap (nal-IRI/Capecitabine) compared to NAPOLI (nal-IRI/5-FU/LV) in patients with gemcitabine-pretreated advanced pancreatic cancer.
Being tested
Irinotecan Liposomal Injection [Onivyde], Capecitabine, 5-fluorouracil, Leucovorin
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • Irinotecan Liposomal Injection [Onivyde]Drug

    Also called nal-IRI

    both arm

  • CapecitabineDrug

    Also called xeloda

    NaliCap

  • 5-fluorouracilDrug

    Also called 5FU

    NAPOLI

  • LeucovorinDrug

    Also called LV

    NAPOLI

Study groups in NCT04371224
Study groupRoleWhat they receive
NaliCapExperimentalnal-IRI/Capecitabine
Receives: Drug: Irinotecan Liposomal Injection [Onivyde]; Drug: Capecitabine
NAPOLIActive comparatornal-IRI/5-FU/LV
Receives: Drug: Irinotecan Liposomal Injection [Onivyde]; Drug: 5-fluorouracil; Drug: Leucovorin

What is being measured

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

  1. Progression-free survival

    Progression-free survival was defined as the duration between randomization and disease progression, any cause of death before disease progression, or the last follow-up.The event was defined as disease progression and any cause of death.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Secondary outcomes (4)

  1. Objective response rate

    Partial response and complete response

    Measured: through study completion, an average of 1 year

  2. Overall survival

    Overall survival was measured from the randomization to the last follow-up or any cause of death. The event was defined as any cause of death.

    Measured: From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 12 months

  3. Adverse events

    Common Terminology Criteria for Adverse Events (CTCAE)_ver 5.0 will be used.

    Measured: through study completion, an average of 1 year

  4. QOL: eortc qlq-c30

    eortc qlq-c30 will be used.

    Measured: through study completion, an average of 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 posted1 May 2020
  2. Study start23 Jun 2020
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (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
Randomised
Intervention model
Parallel groups
Model description
randomized phase 2 study
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04371224
Sponsor's protocol ID
H-1912-090-1089
Acronym
NaliCap
Status last verified
Apr 2024
First submitted
26 Apr 2020
Last updated
19 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan Liposomal Injection [Onivyde], Capecitabine and 5-fluorouracil in people with Pancreatic Cancer, run by Seoul National University Hospital 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 9 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: status not confirmed, as of the sponsor's last update on 19 Apr 2024. 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 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?

Results are not available in the source record.

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

Contact Do-Youn Oh, M.D., PhD. (+82-2-2072-0701, ohdoyoun@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 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 NCT04371224.

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 19 Apr 2024.

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