Solid TumorPhase 1NCT02963389

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim in Pediatric Solid Tumor/Lymphoma Patients

A Phase 1 study testing Tripegfilgrastim in people with Solid Tumor and Lymphoma, run by Dong-A ST Co., Ltd. at 1 site 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

This is an open-label, single ascending dose study to evaluate safety, tolerability, and pharmacokinetics/pharmacodynamics of Tripegfilgrastim in pediatric solid tumor/lymphoma patients Read more about this study

Who is it for?: Ages 6 to 19 years
Conditions the study is for: Solid Tumor, Lymphoma
What is being tested?: Tripegfilgrastim
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteSouth Korea
Study dates: 4 Oct 2016to Nov 2018
Phase: Phase 1
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 6 to 19 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

>=6 and <19-year-old pediatrics with solid tumor/lymphoma
Scheduled for chemotherapy requiring G-CSF support or having given an experience of ANC < 0.5x10^9/L
ANC > 0.75x10^9/L, platelet > 75x10^9/L
ECOG performance status 0 or 1

Who cannot join

Patients with leukemia, myelodysplastic syndrome or uncontrolled infectious/nervous diseases
History of allergy to filgrastim, pegfilgrastim or known hypersensitivity to E-coli derived proteins.
Women who are pregnant or lactating

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Hospital
Seoul, 82

Other trials in South Korea

About this study

Official title: A Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim After Single Administration in Pediatric Solid Tumor/Lymphoma Patients

This is an open-label, single ascending dose study to evaluate safety, tolerability, and pharmacokinetics/pharmacodynamics of Tripegfilgrastim in pediatric solid tumor/lymphoma patients

Conditions: Solid Tumor, Lymphoma
Being tested: Tripegfilgrastim
Medical subject headings: Lymphoma

What participants receive

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

TripegfilgrastimDrug
Also called DA-3031

Study groups in NCT02963389
Study group	Role	What they receive
Tripegfilgrastim 60ug/kg, >=6 and <12-year-old patients	Experimental	A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy Receives: Drug: Tripegfilgrastim
Tripegfilgrastim 60ug/kg, >=12 and <19-year-old patients	Experimental	A single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy Receives: Drug: Tripegfilgrastim
Tripegfilgrastim 100ug/kg, >=6 and <12-year-old patients	Experimental	A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy Receives: Drug: Tripegfilgrastim
Tripegfilgrastim 100ug/kg, >=12 and <19-year-old patients	Experimental	A single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy Receives: Drug: Tripegfilgrastim

What is being measured

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

PK parameter
Time to reach Cmax of Tripegfilgrastim [Tmax]
Measured: Day 1(Hour 0) ~ Day 21
PK parameter
Peak plasma concentration of Tripegfilgrastim [Cmax]
Measured: Day 1(Hour 0) ~ Day 21
PK parameter
Area under the plasma concentration of Tripegfilgrastim versus time curve [AUC]
Measured: Day 1(Hour 0) ~ Day 21
PK parameter
Half-life of Tripegfilgrastim [T1/2]
Measured: Day 1(Hour 0) ~ Day 21
PK parameter
The lowest plasma concentration that Tripegfilgrastim reaches before the next dose is administered [Ctrough]
Measured: Day 1(Hour 0) ~ Day 21

Secondary outcomes (3)

PD parameter
Peak plasma concentration of Absolute Neutrophil Count [ANCmax]
Measured: Day 1(Hour 0) ~ Day 14
PD parameter
Area under the plasma concentration of Absolute Neutrophil Count versus time curve [AUC(ANC)]
Measured: Day 1(Hour 0) ~ Day 14
PD parameter
Time to reach Cmax of Absolute Neutrophil Count [Tmax(ANC)]
Measured: Day 1(Hour 0) ~ Day 14

Timeline

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

4 Oct 2016Nov 2018

First posted15 Nov 2016 (estimated)
Study start4 Oct 2016
Primary completionNov 2018
Study completionNov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Solid TumorStudies of the same condition, open and under way.
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 1
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02963389
Sponsor's protocol ID: DA3031_PNP_I
Status last verified: Jan 2019
First submitted: 13 Oct 2016
Last updated: 15 Jan 2019
Results posted: No

Publications

Lee S, Hong KT, Jang IJ, Yu KS, Kang HJ, Oh J. Semimechanistic pharmacokinetic-pharmacodynamic model of tripegfilgrastim for pediatric patients after chemotherapy. CPT Pharmacometrics Syst Pharmacol. 2023 Sep;12(9):1319-1334. doi: 10.1002/psp4.13012. Epub 2023 Aug 9.
PubMed 37559343
Lee S, Hong KT, Moon SJ, Choi JY, Hong CR, Shin HY, Cho JY, Jang IJ, Yu KS, Oh J, Kang HJ. Pharmacokinetic and Pharmacodynamic Characteristics of Tripegfilgrastim, a Pegylated G-CSF, in Pediatric Patients with Solid Tumors. Clin Pharmacol Ther. 2022 Jan;111(1):293-301. doi: 10.1002/cpt.2433. Epub 2021 Oct 27.
PubMed 34605552

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim After Single Administration in Pediatric Solid Tumor/Lymphoma Patients
ClinicalTrials.gov ID: NCT02963389
Acronym / sponsor ID: DA3031_PNP_I
Conditions: Solid Tumor, Lymphoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
Study start: 4 Oct 2016 (actual)
Primary completion: Nov 2018 (actual)
Study completion: Nov 2018 (actual)
First posted: 15 Nov 2016 (estimated)
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.

This is an open-label, single ascending dose study to evaluate safety, tolerability, and pharmacokinetics/pharmacodynamics of Tripegfilgrastim in pediatric solid tumor/lymphoma patients

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Tripegfilgrastim 60ug/kg, >=6 and <12-year-old patients	Experimental	Drug: TripegfilgrastimA single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy
Tripegfilgrastim 60ug/kg, >=12 and <19-year-old patients	Experimental	Drug: TripegfilgrastimA single dose of Tripegfilgrastim 60ug/kg, S.C, 24hr after completion of chemotherapy
Tripegfilgrastim 100ug/kg, >=6 and <12-year-old patients	Experimental	Drug: TripegfilgrastimA single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy
Tripegfilgrastim 100ug/kg, >=12 and <19-year-old patients	Experimental	Drug: TripegfilgrastimA single dose of Tripegfilgrastim 100ug/kg, S.C, 24hr after completion of chemotherapy

Who may qualify

Ages: 6 to 19 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

>=6 and <19-year-old pediatrics with solid tumor/lymphoma
Scheduled for chemotherapy requiring G-CSF support or having given an experience of ANC < 0.5x10^9/L
ANC > 0.75x10^9/L, platelet > 75x10^9/L
ECOG performance status 0 or 1

Key exclusion criteria (3 listed)

Patients with leukemia, myelodysplastic syndrome or uncontrolled infectious/nervous diseases
History of allergy to filgrastim, pegfilgrastim or known hypersensitivity to E-coli derived proteins.
Women who are pregnant or lactating

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
TripegfilgrastimAlso: DA-3031	Drug	Tripegfilgrastim 100ug/kg, >=12 and <19-year-old patients, Tripegfilgrastim 100ug/kg, >=6 and <12-year-old patients, Tripegfilgrastim 60ug/kg, >=12 and <19-year-old patients, Tripegfilgrastim 60ug/kg, >=6 and <12-year-old patients

Primary outcome

PK parameter
Time frame: Day 1(Hour 0) ~ Day 21
Time to reach Cmax of Tripegfilgrastim [Tmax]
PK parameter
Time frame: Day 1(Hour 0) ~ Day 21
Peak plasma concentration of Tripegfilgrastim [Cmax]
PK parameter
Time frame: Day 1(Hour 0) ~ Day 21
Area under the plasma concentration of Tripegfilgrastim versus time curve [AUC]
PK parameter
Time frame: Day 1(Hour 0) ~ Day 21
Half-life of Tripegfilgrastim [T1/2]
PK parameter
Time frame: Day 1(Hour 0) ~ Day 21
The lowest plasma concentration that Tripegfilgrastim reaches before the next dose is administered [Ctrough]

3 secondary outcomes

PD parameter
Time frame: Day 1(Hour 0) ~ Day 14
PD parameter
Time frame: Day 1(Hour 0) ~ Day 14
PD parameter
Time frame: Day 1(Hour 0) ~ Day 14

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
Derived from this study: PubMed 37559343Lee S, Hong KT, Jang IJ, Yu KS, Kang HJ, Oh J. Semimechanistic pharmacokinetic-pharmacodynamic model of tripegfilgrastim for pediatric patients after chemotherapy. CPT Pharmacometrics Syst Pharmacol. 2023 Sep;12(9):1319-1334. doi: 10.1002/psp4.13012. Epub 2023 Aug 9.
Derived from this study: PubMed 34605552Lee S, Hong KT, Moon SJ, Choi JY, Hong CR, Shin HY, Cho JY, Jang IJ, Yu KS, Oh J, Kang HJ. Pharmacokinetic and Pharmacodynamic Characteristics of Tripegfilgrastim, a Pegylated G-CSF, in Pediatric Patients with Solid Tumors. Clin Pharmacol Ther. 2022 Jan;111(1):293-301. doi: 10.1002/cpt.2433. Epub 2021 Oct 27.

Related trials for Solid Tumor

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

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 1 study testing Tripegfilgrastim in people with Solid Tumor and Lymphoma, run by Dong-A ST Co., Ltd. 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 4 inclusion and 3 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 15 Jan 2019. 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 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.

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?

PK parameter (time frame: Day 1(Hour 0) ~ Day 21). The study lists 5 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 NCT02963389, which also lists 2 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 15 Jan 2019.