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

NCT04371224 | Recruiting Phase 2

• 1 other identifier: H-1912-090-1089
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (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.

  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)

• Objective response rate

  through study completion, an average of 1 year

• Overall survival

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

• Adverse events

  through study completion, an average of 1 year

• QOL: eortc qlq-c30

  through study completion, an average of 1 year

Study Arms (2)

NaliCap

EXPERIMENTAL

nal-IRI/Capecitabine

Drug: Irinotecan Liposomal Injection [Onivyde]; Drug: Capecitabine

NAPOLI

ACTIVE COMPARATOR

nal-IRI/5-FU/LV

Drug: Irinotecan Liposomal Injection [Onivyde]; Drug: 5-fluorouracil; Drug: Leucovorin

Interventions

Irinotecan Liposomal Injection [Onivyde] DRUG

both arm

Also known as: nal-IRI

NAPOLI; NaliCap

Capecitabine DRUG

NaliCap

Also known as: xeloda

NaliCap

5-fluorouracil DRUG

NAPOLI

Also known as: 5FU

NAPOLI

Leucovorin DRUG

NAPOLI

Also known as: LV

NAPOLI

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam-si, 13620, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 110-744, South Korea

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

irinotecan sucrosofate; Capecitabine; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Do-Youn Oh, M.D., PhD.

  Seoul National University Hospital

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

+82-2-2072-0701; ohdoyoun@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized phase 2 study

Study Record Dates

• First Submitted: April 26, 2020
• First Posted: May 1, 2020
• Study Start: June 23, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)