Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers (Dulastin)

November 13, 2023 updated by: Sang Myung Woo, National Cancer Center, Korea

An Open-label, Randomized, Multicenter, Phase II Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers

  • Clinical trial phase: Phase 2
  • Intervention model: Control group
  • Group allocation: Randomized controlled trial
  • Research perspective: Prospective study
  • Participating centers: Multicenter study
  • Definition of the intervention period: Based on the RECIST 1.1 guidelines, patients will receive treatment until dropout due to disease progression or unacceptable toxicity related to the trial drug. Patients will be followed up with to assess survival every 2 months until either death or the end of the trial, whichever is first.
  • The intervention period is from the date of IRB approval to December 31st, 2025
  • The follow-up duration is one year, and the statistical analysis duration is six months
  • The total research period is from the date of IRB approval to June 30th, 2026

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pancreatic cancer and Bile duct cancer are the 8th and 9th leading causes of all cancer in Korea, have 5-year survival rates of approximately 20%, and unresectable cancers show a poor prognosis of approximately 5%. The first-line treatment recommended for unresectable pancreaticobiliary cancer is chemotherapy. FOLFIRINOX or gemcitabine/nab-paclitaxel combination therapy is recommended for pancreatic cancer, and gemcitabine/cisplatin combination therapy is recommended for bile duct cancer. Recently, anticancer therapy advances have led to an increase in survival for pancreaticobiliary cancer patients, and more than half of patients receive secondary chemotherapy due to disease progression after first-line treatment. Recently, with the introduction of nanoliposomal irinotecan (nal-IRI) and the clinical outcomes of Phase 3 NAPOL-1 trial and the Phase 2b NIFTY trial, nal-IRI/5-FU/LV combination therapy is being used as second-line chemotherapy following gemcitabine treatment. Granulocyte colony-stimulating factors (G-CSFs) (filgrastim, pegfilgrastim, and tripegfilgrastim) can be used for neutropenia prevention and treatment. In particular, pegylated G-CSF can reduce patient discomfort due to its long retention time. In a retrospective study analyzing the use of G-CSF for primary neutropenia prevention in Korea, pancreatic cancer patients who received FOLFIRINOX treatment that exhibited neutropenia and FN were significantly reduced from 55.6% to 31.6% (P = 0.003) and from 18.5% to 1.8% (P = 0.002), respectively. Similarly, in a retrospective study in Japan, preventive pegylated G-CSF treatment reduced the incidence of FN from 23% to 0%, and in a double-blinded, randomized, phase 3 breast cancer clinical trial, pegylated G-CSF treatment significantly reduced the incidence of FN from 68.8% to 1.2%. In a retrospective study of non-small cell lung cancer, another solid cancer, the incidence of FN in the preventive pegylated G-CSF treatment group was 0%, compared to an incidence of 50% in the control group.

However, no studies have evaluated the efficacy of G-CSF in pancreaticobiliary cancer patients receiving nal-IRI/5-FU/LV combination therapy yet. Hence, our objective was to report the effects of pegylated G-CSF on preventing severe neutropenia in patients receiving nal-IRI/5-FU/LV combination chemotherapy for unresectable pancreaticobiliary cancer.

Study Type

Interventional

Enrollment (Estimated)

98

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Sangmyung Woo, M.D
  • Phone Number: 82-31-920-1733
  • Email: wsm@ncc.re.kr

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged at least 19 years old, diagnosed with unresectable pancreaticobiliary cancer, and scheduled to receive chemotherapy using nal-IRI/5-FU/LV combination chemotherapy

Exclusion Criteria:

  • Patients who refuse to sign the consent form Patients who have previously experienced severe neutropenia during chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
  • Premedication: depending on the center (Ondansetron 8 mg +Dextrose 5% 50 mL, MIV, Dexamethason 10 mg IV, and Atropine sulfate 0.25 mg [0.5 amp] SC)
  • Onivyde 70 mg/m2 + Dextrose 5% 500 mL (bag), and MIV for 90 min
  • Leucovorin 400 mg/m2 + Dextrose 5% 500 mL (bag), and MIV for 30 min
  • 5-FU (2400 mg/m2) + Dextrose 5% 500 mL (bag) and MIV for 46 h
  • Tripegfilgrastim 6 mg SC administered 24 h after completing 5-FU infusion The above chemotherapy will be administered every two weeks
Drug: Tripegfilgrastim
Tripegfilgrastim to reduce the risk of severe neutropenia in patients with unresectable pancreaticobiliary cancers
Other Names:
  • Dulastin
No Intervention: Control Group
  • Premedication: depending on center (Ondansetron 8 mg+Dextrose 5% 50 mL, MIV, Dexamethason 10 mg IV, and Atropine sulfate 0.25 mg [0.5 amp] SC)
  • Onivyde 70 mg/m2 + Dextrose 5% 500 mL (bag), and MIV for 90 min
  • Leucovorin 400 mg/m2 + Dextrose 5% 500 mL (bag), and MIV for 30 min
  • 5-FU (2400 mg/m2) + Dextrose 5% 500 mL (bag), and MIV for 46 h The following medication will be provided in the event that the patient develops febrile neutropenia after the above chemotherapy
  • Tripegfilgrastim 6 mg SC administered 24 h after stopping 5-FU. In the event of neutropenia, chemotherapy will be paused until the patient recovers, and then restarted after recovery.
  • The above chemotherapy will be administered every two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary endpoint
Time Frame: through study completion, an average of 1 year
Severe neutropenia incidence
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neutropenia incidence
Time Frame: through study completion, an average of 1 year
All grades of neutropenia incidence
through study completion, an average of 1 year
Febrile neutropenia
Time Frame: through study completion, an average of 1 year
Febrile neutropenia incidence
through study completion, an average of 1 year
emergency department visits
Time Frame: through study completion, an average of 1 year
Frequency of unexpected emergency department visits and length of stay
through study completion, an average of 1 year
Overall survival
Time Frame: through study completion, an average of 1 year
Overall survival
through study completion, an average of 1 year
Progression-free survival
Time Frame: through study completion, an average of 1 year
Progression-free survival
through study completion, an average of 1 year
biomarkers
Time Frame: through study completion, an average of 1 year
Predictive biomarkers for treatment response analysis
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Collaborators

Seoul National University Hospital

Investigators

  • Principal Investigator: Sangmyung Woo, M.D, National Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 10, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Estimated)

November 16, 2023

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC2023-0235

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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