Locally Advanced Pancreatic CancerPhase 2NCT06353581
Prophylactic Administration of Neulapeg (Pegteograstim) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Receiving the Modified FOLFIRINOX
A Phase 2 study testing Neulapeg in people with Locally Advanced Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Neutropenia, a decrease in the number of neutrophils, a type of white blood cell, due to the myelosuppressive effects of chemotherapeutic drugs, is a frequent occurrence in patients receiving anticancer drug therapy, which increases the risk of infection, which can have serious consequences such as antibiotic… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Locally Advanced Pancreatic Cancer, Metastatic Pancreatic Cancer
- What is being tested?
- Neulapeg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Feb 2022to 8 May 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pancreatic cancer assessed as locally advanced or metastatic by histology/cytology or imaging studies including CT or MRI
- Patients who are scheduled to receive modified FOLFIRINOX chemotherapy (less than second-line treatment as a consolidation regimen)
- Patients with an ECOG performance capacity index of 0 to 1
- Patients 19 years of age or older who are willing and able to complete a written informed consent for this study
- Patients with adequate organ function
- Patients who voluntarily agree to participate in the study
Who cannot join
- Other histologic/cytologic or imaging diagnosis other than pancreatic ductal adenocarcinoma (e.g., neuroendocrine tumor, etc.)
- Patients with moderate acute or chronic medical conditions or abnormal laboratory findings that would affect the results of this study.
- Pregnant or lactating women or patients planning to become a mother during the scheduled study period from the screening visit through Day 120 after the last dose of study drug
- Active systemic infection that is not resolving
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Open Label Study of the Efficacy and Safety of Neulapeg (Pegteograstim) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Treated With Modified FOLFIRINOX
Neutropenia, a decrease in the number of neutrophils, a type of white blood cell, due to the myelosuppressive effects of chemotherapeutic drugs, is a frequent occurrence in patients receiving anticancer drug therapy, which increases the risk of infection, which can have serious consequences such as antibiotic treatment, hospitalization, intensive care unit treatment, and death, and also reduces the effectiveness of anticancer treatment due to dose reduction and cycle delay. Therefore,G-CSF,which acts as a neutrophil growth factor, can be administered immediately after chemotherapy to increase the production rate of neutrophils and promote the efflux of mature neutrophils from the bone marrow, thereby increasing the absolute neutrophil count. Guidelines for the use of G-CSF published by the NCCN indicate that primary prophylaxis with G-CSF has clinical benefit for patients receiving anticancer drug therapy with a risk of febrile neutropenia greater than 20%. For those at 10-20% risk, consider primary prophylaxis based on risk factors. The frequency of neutropenic fever with FOLFIRINOX chemotherapy, which is commonly used in patients with locally advanced or metastatic pancreatic cancer, was 5.4% in a prospective study of patients receiving high-dose regimens, but 42.5% of patients received prophylactic G-CSF, and 63.0% of patients received prophylactic G-CSF compared to 3.0% when given as postoperative adjuvant therapy demonstrating the need for G-CSF administration.In a retrospective study in Japan, a modified FOLFIRINOX chemotherapy regimen without pegylated G-CSF was associated with a 23% incidence of neutropenic fever and 61.5% grade 3-4 neutropenia, while prophylactic administration of pegylated G-CSF was associated with zero neutropenic fever and grade 3-4 neutropenia and longer survival .A retrospective study from Korea also reported that prophylactic G-CSF administration reduced neutropenic fever from 18.5% to 1.8% and Grade 3-4 neutropenia from 55.6% to 31.6 in pancreatic cancer patients receiving FOLFIRINOX .Pegteograstim (Neulapeg®) is a pegylated human recombinant granulocyte colony-stimulating factor with a long half-life (15-80 hours) compared to filgrastim (3-4 hours). Although several studies have demonstrated that G-CSF primary prophylaxis reduces the frequency of hematologic toxicities, particularly febrile neutropenia, during chemotherapy, it has not been prospectively studied whether primary prophylaxis reduces the frequency of grade 3-4 neutropenia and neutropenic fever in the modified FOLFIRINOX chemotherapy regimen in patients with pancreatic cancer. Therefore, this study is designed to determine if prophylactic administration of NEURAPEC reduces the frequency of Grade 3-4 neutropenia and neutropenic fever in patients with locally advanced or metastatic pancreatic cancer receiving modified FOLFIRINOX chemotherapy.
Read the detailed description
- Subjects who meet the inclusion/exclusion criteria for this study will be randomized to two arms, Arm A and Arm B, alternating between patients receiving prophylactic Neulapeg and patients not receiving prophylactic Neulapeg. Once assigned, they will be followed until the end of the 8th cycle of modified FOLFIRINOX.
- Patients assigned to the arm receiving prophylactic Neulapeg will receive Neulapeg subcutaneously 24 hours after the end of modified FOLFIRINOX dosing. (This should be administered no later than 72 hours, and Neulapeg will only be given for a maximum of 8 cycles.)
- Patients in both arms will have additional visits at the discretion of the investigator for hematologic toxicity surveillance on days 7-10 of modified FOLFIRINOX dosing during the first 4 cycles. Thereafter, patients will be seen only at the time of chemotherapy administration at the discretion of the investigator.
- Patients in both arms will be instructed to return for any fever greater than 38.3 degrees Celsius or greater than 38.0 degrees Celsius lasting more than 1 hour.
- Patients assigned to the arm not receiving prophylactic Neulapeg will not receive intervention with G-CSF for neutropenia of grade 2 or less.
- Patients assigned to the no prophylactic Neulapeg arm will be crossover to prophylactic Neulapeg if they develop Grade 3-4 neutropenia or neutropenic fever. Crossover subjects will receive up to 8 cycles of prophylactic Neulapeg as a secondary treatment regardless of starting cycle.
- Hematologic toxicity monitored every cycle for 8 cycles / Quality of life assessed according to EORTC QLQ-C30 at baseline, once every 2 weeks for a total of 5 times (Baseline, Cycle 2 Day 1, Cycle 4 Day1 , Cycle 6 Day 1 , Cycle 8 Day 1) / completion of the bone pain questionnaire at baseline, once every 1 cycle for the first 4 cycles, and then every 2 cycles for a total of 7 times (Baseline, Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 6 Day 1, Cycle 8 Day 1). The mFOLFIRINOX will be administered every 2 weeks for up to 8 cycles, while Neulapeg will be administered within 24-72 hours of the end of dosing and will be available for up to 8 cycles only. The crossover control arm will continue as usual.
- The modified FOLFIRINOX chemotherapy regimen will be administered at the original dose at the start of Cycle 1, with subsequent dose deferral until recovery of a neutrophil count ≥1,000 /mm3 in the event of toxicity, with dose reduction at the discretion of the investigator.
- Being tested
- Neulapeg, Control
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeulapegDrug
Participants will receive Neulapeg subcutaneously 24 hours after the end of modified FOLFIRINOX dosing. (Must be administered within a maximum of 72 hours; Neulapeg will only be given for up to 8 cycles).
ControlOther
Patients assigned to the non-Neulapeg arm will be crossover to Neulapeg if they develop grade 3-4 neutropenia or neutropenic fever. Crossover subjects will receive up to 8 cycles of Neulapeg as a secondary treatment regardless of starting cycle.
| Study group | Role | What they receive |
|---|---|---|
| Neulapeg | Experimental | Neulapeg Receives: Drug: Neulapeg; Other: Control |
| Control | No intervention | If grade 3-4 neutropenia or neutropenic fever occurs, patients will be crossover to Neulapeg. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of grade 3-4 neutropenia (grade 3-4 neutropenia, ANC<1000/mL)
The occurrence of grade 3-4 neutropenia (grade 3-4 neutropenia, ANC<1000/mL) and the occurrence of neutropenic fever (febrile neutropenia) will be tested using the chi-squared test.
Measured: 4 years
development of neutropenic fever (febrile neutropenia)
The occurrence of grade 3-4 neutropenia (grade 3-4 neutropenia, ANC<1000/mL) and the occurrence of neutropenic fever (febrile neutropenia) will be tested using the chi-squared test.
Measured: 4 years
Secondary outcomes (8)
relative dose intensity
Relative dose intensity: proportion of administrated dose per m2 of BSA per week in relation to optimal dose per m2 of BSA per week
Measured: 4 years
quality of life assessed according to EORTC QLQ-C30
The EORTC QLQ-C30 assesses health-related quality of life in cancer patients participating in clinical trials. The EORTC QLQ-C30 comprises 5 functional scales (physical, role, emotional, social, cognitive), 8 single-item symptom scales (fatigue, pain, nausea/vomiting, appetite loss, constipation, diarrhea, insomnia, and dyspnea), as well as subscales assessing global health/quality of life and financial impact. Raw scores are transformed to a scale of 0 to 100, with higher scores representing better functioning/quality of life and greater symptom burden.
Measured: 4 years
Number of patients experiencing Adverse events (AEs)
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention whether or not considered related to the study intervention.
Measured: 4 years
objective response rate
Objective response rate is defined as the proportion of participants with a complete response (CR) or partial response (PR) based on RECIST v1.1
Measured: 4 years
Progression-free survival
Progression-free survival is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 per investigator or death from any cause.
Measured: 4 years
Overall survival
Overall survival is defined as the time from randomization to the event of death from any cause.
Measured: 4 years
Change in blood cytokine concentrations
Changes in blood cytokine concentrations: measured by ELISA, tested by t-test G-CSF induced bone pain assessed by questionnaire G-CSF induced bone pain modality, assessed by questionnaire, will be measured by the area under the curve (AUC) of the pain scores recorded by the patients. objective response rate according to CTCAE v5.0 will be tested using the chi-squared test will be used to test for differences in adverse events and objective response rates according to CTCAE v5.0.
Differences in progression-free survival, overall survival, and progression-free survival will be analyzed using the Kaplan-Meier test. (overall survival) .Questionnaire-based endpoints such as QOL will be assessed up to Week 8. QOL and other survey-based endpoints will continue to be administered up to cycle 8, and survival will only be validated in patients who did non-crossover
Measured: 4 years
G-CSF induced bone pain as assessed by questionnaires
G-CSF induced bone pain assessed by questionnaire G-CSF induced bone pain modality, assessed by questionnaire, will be measured by the area under the curve (AUC) of the pain scores recorded by the patients.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start16 Feb 2022
- Primary completion8 May 2024 (estimated)
- Study completion8 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353581
- Sponsor's protocol ID
- 4-2021-0924
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee CK, Kim I, Seo DH, Park S, Kim M, Lee SH, Lee YJ, Kim JH, Kim CG, Choi HJ. Pegylated granulocyte colony-stimulating factor primary prophylaxis versus no prophylaxis in patients with unresectable pancreatic cancer treated with modified-FOLFIRINOX: a randomized, open-label, multicenter, phase 2 trial. EClinicalMedicine. 2025 Nov 14;90:103646. doi: 10.1016/j.eclinm.2025.103646. eCollection 2025 Dec.
PubMed 41324016
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open Label Study of the Efficacy and Safety of Neulapeg (Pegteograstim) in Patients With Locally Advanced or Metastatic Pancreatic Cancer Treated With Modified FOLFIRINOX
- ClinicalTrials.gov ID
- NCT06353581
- Acronym / sponsor ID
- 4-2021-0924
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 8 May 2024 (estimated)
- Study completion
- 8 May 2024 (estimated)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neutropenia, a decrease in the number of neutrophils, a type of white blood cell, due to the myelosuppressive effects of chemotherapeutic drugs, is a frequent occurrence in patients receiving anticancer drug therapy, which increases the risk of infection, which can have serious consequences such as antibiotic treatment, hospitalization, intensive care unit treatment, and death, and also reduces the effectiveness of anticancer treatment due to dose reduction and cycle delay. Therefore,G-CSF,which acts as a neutrophil growth factor, can be administered immediately after chemotherapy to increase the production rate of neutrophils and promote the efflux of mature neutrophils from the bone marrow, thereby increasing the absolute neutrophil count. Guidelines for the use of G-CSF published by the NCCN indicate that primary prophylaxis with G-CSF has clinical benefit for patients receiving anticancer drug therapy with a risk of febrile neutropenia greater than 20%. For those at 10-20% risk, consider primary prophylaxis based on risk factors. The frequency of neutropenic fever with FOLFIRINOX chemotherapy, which is commonly used in patients with locally advanced or metastatic pancreatic cancer, was 5.4% in a prospective study of patients receiving high-dose regimens, but 42.5% of patients received prophylactic G-CSF, and 63.0% of patients received prophylactic G-CSF compared to 3.0% when given as postoperative adjuvant therapy demonstrating the need for G-CSF administration.In a retrospective study in Japan, a modified FOLFIRINOX chemotherapy regimen without pegylated G-CSF was associated with a 23% incidence of neutropenic fever and 61.5% grade 3-4 neutropenia, while prophylactic administration of pegylated G-CSF was associated with zero neutropenic fever and grade 3-4 neutropenia and longer survival .A retrospective study from Korea also reported that prophylactic G-CSF administration reduced neutropenic fever from 18.5% to 1.8% and Grade 3-4 neutropenia from 55.6% to 31.6 in pancreatic cancer patients receiving FOLFIRINOX .Pegteograstim (Neulapeg®) is a pegylated human recombinant granulocyte colony-stimulating factor with a long half-life (15-80 hours) compared to filgrastim (3-4 hours). Although several studies have demonstrated that G-CSF primary prophylaxis reduces the frequency of hematologic toxicities, particularly febrile neutropenia, during chemotherapy, it has not been prospectively studied whether primary prophylaxis reduces the frequency of grade 3-4 neutropenia and neutropenic fever in the modified FOLFIRINOX chemotherapy regimen in patients with pancreatic cancer. Therefore, this study is designed to determine if prophylactic administration of NEURAPEC reduces the frequency of Grade 3-4 neutropenia and neutropenic fever in patients with locally advanced or metastatic pancreatic cancer receiving modified FOLFIRINOX chemotherapy.
Detailed description
- Subjects who meet the inclusion/exclusion criteria for this study will be randomized to two arms, Arm A and Arm B, alternating between patients receiving prophylactic Neulapeg and patients not receiving prophylactic Neulapeg. Once assigned, they will be followed until the end of the 8th cycle of modified FOLFIRINOX.
- Patients assigned to the arm receiving prophylactic Neulapeg will receive Neulapeg subcutaneously 24 hours after the end of modified FOLFIRINOX dosing. (This should be administered no later than 72 hours, and Neulapeg will only be given for a maximum of 8 cycles.)
- Patients in both arms will have additional visits at the discretion of the investigator for hematologic toxicity surveillance on days 7-10 of modified FOLFIRINOX dosing during the first 4 cycles. Thereafter, patients will be seen only at the time of chemotherapy administration at the discretion of the investigator.
- Patients in both arms will be instructed to return for any fever greater than 38.3 degrees Celsius or greater than 38.0 degrees Celsius lasting more than 1 hour.
- Patients assigned to the arm not receiving prophylactic Neulapeg will not receive intervention with G-CSF for neutropenia of grade 2 or less.
- Patients assigned to the no prophylactic Neulapeg arm will be crossover to prophylactic Neulapeg if they develop Grade 3-4 neutropenia or neutropenic fever. Crossover subjects will receive up to 8 cycles of prophylactic Neulapeg as a secondary treatment regardless of starting cycle.
- Hematologic toxicity monitored every cycle for 8 cycles / Quality of life assessed according to EORTC QLQ-C30 at baseline, once every 2 weeks for a total of 5 times (Baseline, Cycle 2 Day 1, Cycle 4 Day1 , Cycle 6 Day 1 , Cycle 8 Day 1) / completion of the bone pain questionnaire at baseline, once every 1 cycle for the first 4 cycles, and then every 2 cycles for a total of 7 times (Baseline, Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 6 Day 1, Cycle 8 Day 1). The mFOLFIRINOX will be administered every 2 weeks for up to 8 cycles, while Neulapeg will be administered within 24-72 hours of the end of dosing and will be available for up to 8 cycles only. The crossover control arm will continue as usual.
- The modified FOLFIRINOX chemotherapy regimen will be administered at the original dose at the start of Cycle 1, with subsequent dose deferral until recovery of a neutrophil count ≥1,000 /mm3 in the event of toxicity, with dose reduction at the discretion of the investigator.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neulapeg | Experimental | Drug: Neulapeg, Other: ControlNeulapeg |
| Control | No intervention | –If grade 3-4 neutropenia or neutropenic fever occurs, patients will be crossover to Neulapeg. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with pancreatic cancer assessed as locally advanced or metastatic by histology/cytology or imaging studies including CT or MRI
- Patients who are scheduled to receive modified FOLFIRINOX chemotherapy (less than second-line treatment as a consolidation regimen)
- Patients with an ECOG performance capacity index of 0 to 1
- Patients 19 years of age or older who are willing and able to complete a written informed consent for this study
- Patients with adequate organ function
Key exclusion criteria (4 listed)
- Other histologic/cytologic or imaging diagnosis other than pancreatic ductal adenocarcinoma (e.g., neuroendocrine tumor, etc.)
- Patients with moderate acute or chronic medical conditions or abnormal laboratory findings that would affect the results of this study.
- Pregnant or lactating women or patients planning to become a mother during the scheduled study period from the screening visit through Day 120 after the last dose of study drug
- Active systemic infection that is not resolving
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeulapegParticipants will receive Neulapeg subcutaneously 24 hours after the end of modified FOLFIRINOX dosing. (Must be administered within a maximum of 72 hours; Neulapeg will only be given for up to 8 cycles). | Drug | Neulapeg |
| ControlPatients assigned to the non-Neulapeg arm will be crossover to Neulapeg if they develop grade 3-4 neutropenia or neutropenic fever. Crossover subjects will receive up to 8 cycles of Neulapeg as a secondary treatment regardless of starting cycle. | Other | Neulapeg |
Primary outcome
Development of grade 3-4 neutropenia (grade 3-4 neutropenia, ANC<1000/mL)
Time frame: 4 years
The occurrence of grade 3-4 neutropenia (grade 3-4 neutropenia, ANC<1000/mL) and the occurrence of neutropenic fever (febrile neutropenia) will be tested using the chi-squared test.
development of neutropenic fever (febrile neutropenia)
Time frame: 4 years
The occurrence of grade 3-4 neutropenia (grade 3-4 neutropenia, ANC<1000/mL) and the occurrence of neutropenic fever (febrile neutropenia) will be tested using the chi-squared test.
8 secondary outcomes
relative dose intensity
Time frame: 4 years
quality of life assessed according to EORTC QLQ-C30
Time frame: 4 years
Number of patients experiencing Adverse events (AEs)
Time frame: 4 years
objective response rate
Time frame: 4 years
Progression-free survival
Time frame: 4 years
Overall survival
Time frame: 4 years
Change in blood cytokine concentrations
Time frame: 4 years
G-CSF induced bone pain as assessed by questionnaires
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Derived from this study: PubMed 41324016Lee CK, Kim I, Seo DH, Park S, Kim M, Lee SH, Lee YJ, Kim JH, Kim CG, Choi HJ. Pegylated granulocyte colony-stimulating factor primary prophylaxis versus no prophylaxis in patients with unresectable pancreatic cancer treated with modified-FOLFIRINOX: a randomized, open-label, multicenter, phase 2 trial. EClinicalMedicine. 2025 Nov 14;90:103646. doi: 10.1016/j.eclinm.2025.103646. eCollection 2025 Dec.
- Individual participant dataSharing planned: No
Related trials for Locally Advanced Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
CREO - Microwave Ablation Feasibility Study
Pancreatic Cancer, Liver Cancer (Locally Advanced or Metastatic)
RecruitingPhase 1
Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma
Pancreatic Cancer
Active, not recruitingPhase 1/2
Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer
Locally Advanced Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8
Active, not recruitingPhase 2
Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neulapeg in people with Locally Advanced Pancreatic Cancer and Metastatic Pancreatic Cancer, run by Yonsei University at 1 site 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 6 inclusion and 4 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 9 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 1 site 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?
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?
Development of grade 3-4 neutropenia (grade 3-4 neutropenia, ANC<1000/mL) (time frame: 4 years). 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 NCT06353581, which also lists 1 linked publication.
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 9 Apr 2024.