이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

화학 요법으로 유발 된 메스꺼움 예방 및 소아암 환자에서 고도로 emetogenic 화학 요법 (HEC)의 구토를 예방하기위한 IV NEPA (Fosnetupitant/Palonosetron)에 대한 연구

2026년 9월 28일 업데이트: Helsinn Healthcare SA

IV NEPA (Fosnetupitant/palonosetron)를 통한 다중 센터, 다국적, 약동학 적, 안전성 및 효능 연구는 화학 요법에 의한 메스꺼움을 예방하고 소아 암 환자에서 고화증 화학 요법 (HEC)을 겪고 있습니다. 1 일 HEC (1 일 HEC)의 1 일 HEC 및 반복적 인 복용량 IV NEPA에서 2 단계, 오픈-라벨, 무작위, 단일 용량 IV NEPA 대 FOSAPREPITANT/ONDANSETRON을 사용한 2- 부분 연구.

Chemotherapy often causes nausea and vomiting (CINV), and this is a major problem for the children being treated for cancer. To prevent this, a combination of two substances in fixed proportion (IV NEPA) was developed. The two substances are: palonosetron, an antagonist of 5 HT3 receptors, and fosnetupitant, an antagonist of NK1 receptors that transforms into netupitant in the body. The medication is administered through intravenous injection (IV- drip).

This study is built from 2 parts:

Part 1: phase 2, open label Part 2: phase 3 double blind

The detailed description, study design, study milestones and eligibility criteria will reflect the Part 1 requirements

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Part I of the study is a Phase 2, open-label, randomised (for Cohort 1 only), single chemotherapy cycle study which will compare single-dose of IV NEPA to another treatment (fosaprepitant/ondansetron) considered as a standard of care, in patients receiving single-day chemotherapy that has a high possibility to generate a vomiting episode (HEC) (Cohort 1) and assess repeated dose of IV NEPA in patients receiving multi day HEC chemotherapy (Cohort 2).

Because this will be the first study testing the IV NEPA in children, Part I will enroll patients from older to younger age groups with safety checks before moving to the next group.

연구 유형

중재적

등록 (추정된)

95

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 그리스
      • Athens, 그리스
        • 모병
        • Aghia Sophia Children's Hospital, Pediatric Hematology/ Oncology Unit (POHemU)
      • Thessaloniki, 그리스
        • 빼는
        • "AHEPA" University General Hospital of Thessaloniki, 2nd Department of Pediatrics
  • 루마니아
      • Bucharest, 루마니아
        • 모병
        • Fundeni Clinical Institute, Pediatric Hematology and BMT
      • Bucharest, 루마니아
        • 모병
        • Oncology Institute "Prof. Dr. Al. Trestioreanu", Pediatric Oncology
      • Timișoara, 루마니아
        • 모병
        • Emergency Children's Hospital " Louis Turcanu, Oncology-Haematology and BMP department
  • 터키 (Türkiye)
      • Ankara, 터키 (Türkiye)
        • 모병
        • Gazi University Gazi Hospital Children Hematology and Oncology
      • Ankara, 터키 (Türkiye)
        • 모병
        • Hacettepe University Hospitals Oncology Hospital 2nd Floor Children Oncology
    • Faith
      • Istanbul, Faith, 터키 (Türkiye)
        • 아직 모집하지 않음
        • Istanbul University Istanbul Faculty of Medicine Topkapı
    • Mamak
      • Ankara, Mamak, 터키 (Türkiye)
        • 모병
        • Ankara University Faculty of Medicine Children's Hospital, Department of Children Oncology and Hematology
    • Melikgazi
      • Kayseri, Melikgazi, 터키 (Türkiye)
        • 모병
        • Erciyes University Hospitals Kanka Children's Hematology Oncology and Bone Marrow Hospital
  • 폴란드
      • Bialystok, 폴란드
        • 빼는
        • Department of Pediatrics, Oncology and Hematology University Children's Clinical Hospital them. Ludwik Zamenhof in Bialystok
      • Bydgoszcz, 폴란드, 85-667
        • 모병
        • Department of Paediatrics, Haematology, Oncology and Rheumatology Voivodship Children's Hospital them. J. Brudziński
      • Lodz, 폴란드
        • 모병
        • Clinic of Pediatrics, Oncology and Hematology University Pediatric Center them M. Konopnicka SP ZOZ Central Clinical Hospital Medical University of Lodz
      • Lublin, 폴란드, 20-093
        • 아직 모집하지 않음
        • University Children'S Hospital in Lublin, Department of Pediatric Hematology, Oncology, and Transplantology
      • Olsztyn, 폴란드
        • 빼는
        • Clinical Department of Paediatric Oncology and Haematology VOIVODSHIP SPECIALIST CHILDREN'S HOSPITAL them. prof. dr. Stanisław Popowski in Olsztyn
      • Poznan, 폴란드
        • 모병
        • Department of Pediatric Oncology, Hematology and Transplantation Clinical Hospital them. Karol Jonscher Medical University them. Karol Marcinkowski in Poznań
      • Szczecin, 폴란드
        • 빼는
        • Department of Paediatrics and Paediatric Haemato-Oncology University Clinical Hospital No. 1 them. prof. Tadeusz Sokołowski Pomeranian Medical University
      • Szczecin, 폴란드
        • 빼는
        • Department of Paediatrics, Oncology and Paediatric Immunology, University Clinical Hospital No. 1 them. prof. Tadeusz Sokołowski Pomeranian Medical University in Szczecin
      • Warsaw, 폴란드
        • 모병
        • Department of Oncology and Surgical Oncology for Children and Youth Institute Mother and Child
      • Warsaw, 폴란드
        • 모병
        • Department of Oncology Institute "Monument - Child Health Center"

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

1초 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

The following inclusion criteria must be checked prior to study inclusion:

  1. Signed written Informed Consent Form (ICF) by parent(s)/legal guardian of the paediatric patient in compliance with the local laws and regulations. In addition, the signed children's Assent Form according to local requirements.

  2. Male or female in- or out-patient from 0 months (newborns) to <18 years on the date of enrolment (Day 1).

  3. Cohort 1: Patient < 6 months weighing at least 4 kg or patient ≥ 6 months weighing at least 6 kg.

    Cohort 2: Patient weighing at least 4 kg.

  4. Patient with a predicted life expectancy ≥3 months according to Investigator's opinion.

  5. Patient naïve or non-naïve to chemotherapy, with histologically and/or cytologically (or imaging in the case of brain tumours and nephroblastomas) confirmed malignant disease.

  6. Cohort 1: Patient scheduled and eligible to receive at least 1 cycle of single-day HEC.

    Cohort 2: Patient scheduled and eligible to receive at least 1 cycle of multi-day HEC.

    (For the level of emetogenicity of the chemotherapeutic agents, refer to the POGO January 2021 guideline).

  7. For patients aged ≥10 years: Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤2.

  8. For patient with known hepatic impairment: the patient may be enrolled provided the serum ALT and AST are ≤2.5 ULN, the total bilirubin is ≤1.5 ULN, and in the Investigator's opinion the impairment is not expected to jeopardize the patient's safety during the study.

  9. For patient with known renal impairment: the patient may be enrolled provided the estimated glomerular filtration rate (eGFR) is ≥70 mL/min/1.73m2 (≥50 mL/min/1.73m2 for children <3 months old) (the eGFR should be calculated using the modified Schwartz equation) and in the Investigator's opinion the impairment is not expected to jeopardize the patient's safety during the study.

  10. For patient with known history or predisposition to cardiac abnormalities: as per the Investigator's opinion, the history/predisposition should not jeopardize patient's safety during the study.

  11. Patient with non-clinically significant abnormal laboratory values or with clinically relevant abnormal laboratory values may be enrolled if in the Investigator's opinion the patient's safety is not expected to be jeopardized.

  12. Female patient shall: a) not have attained menarche yet or b) have attained menarche and have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at Day 1.

  13. Male or female fertile patient using reliable contraceptive measures. Such measures, for patient and sexual partner, include: implants, injectables, combined oral contraceptives, intrauterine devices, vasectomized/sterilized partner, use of a double barrier method, or sexual abstinence. The patient and his/her parent(s)/legal guardian must be counselled on the importance of avoiding pregnancy before and during the study.

Exclusion Criteria:

  1. The patient and/or parent(s)/legal guardian are expected by the Investigator to be non compliant with the study procedures.

  2. Patient has received or is scheduled to receive total body irradiation; total nodal irradiation; upper abdomen radiotherapy; half or upper body irradiation; or radiotherapy of the cranium, craniospinal regions, head and neck, lower thorax region, or the pelvis within 1 week prior to study entry (Day 1) or within 120 h after start of chemotherapy on Day 1 (Cohort 1 patients) or within 168 h (for Cohort 2 patients receiving the last IV NEPA on Day 3) or 216 h (for Cohort 2 patients receiving the last IV NEPA on Day 5) from start of chemotherapy on Day 1.

  3. Known history of allergy to any component of the study treatments or other contraindications to any NK1-RAs or 5-HT3-RAs.

  4. Active infection.

  5. Any illness or condition that, in the opinion of the Investigator, may pose unwarranted risks in administering the investigational product to the patient.

  6. Uncontrolled medical condition (e.g., uncontrolled insulin-dependent diabetes mellitus).

  7. Patient experiencing ongoing vomiting from any organic aetiology (including patients with history of gastric outlet obstruction or intestinal obstruction due to adhesions or volvulus), or patient with hydrocephalus.

  8. Patient who experienced any vomiting, retching, or nausea within 24 h prior to the administration of the study treatment on Day 1 (Note: functional vomiting for infants, which is normally seen during the first 3 months of life, is not to be considered as vomiting).

  9. Patient who received any drug with potential antiemetic effect within 24 h prior to administration of study treatment on Day 1, including but not limited to the following:

    • NK1-RAs (e.g., (fos)aprepitant or any other drug of this class)
    • 5-HT3-RAs (e.g., ondansetron, granisetron, dolasetron, tropisetron, ramosetron)
    • Benzamides (e.g., metoclopramide, alizapride)
    • Phenothiazines (e.g., prochlorperazine, promethazine, perphenazine, fluphenazine, chlorpromazine, thiethylperazine)
    • Benzodiazepines initiated 48 h prior to study treatment administration on Day 1 or expected to be administered within the efficacy assessment period, except for single doses of midazolam, temazepam, or triazolam
    • Butyrophenones (e.g., droperidol, haloperidol)
    • Anticholinergics (e.g., scopolamine, except the inhaled anticholinergics for respiratory disorders e.g., ipratropium bromide)
    • Antihistamines (e.g., diphenhydramine, cyclizine, hydroxyzine, chlorphenhyramine, dimenhydrinate, meclizine)
    • Domperidone
    • Mirtazapine
    • Olanzapine
    • Prescribed cannabinoids (e.g., tetrahydrocannabinol, nabilone)
    • Over-the-counter (OTC) antiemetics, OTC cold medications, or OTC allergy medications
    • Herbal preparations containing ephedra or ginger

  10. Patient who received palonosetron within 1 week prior to administration of study treatment on Day 1.

  11. Patient receiving systemic corticosteroid therapy above 0.14mg/kg or >10 mg of prednisone daily or equivalent.

    Exception:

    Dexamethasone for the prevention of CINV is permitted in association with the study treatment (Test Treatment and Reference Treatment) as per standard of care and applicable guidelines, provided its dosage is reduced by 50% in consideration of known interactions with various NK1 RAs, including fosaprepitant and fosnetupitant.

  12. Patient aged <6 years who received any investigational drug (defined as a medication with no marketing authorization granted for any age or indication) within 90 days prior to Day 1, or patient aged ≥6 years who received any investigational drug within 30 days prior to Day 1, or patient any age who is expected to receive investigational drugs prior to study completion.

  13. Intake of alcohol, food, or beverages (e.g., grapefruit, cranberry, pomegranate, and aloe vera juices; German chamomile) known to interfere with CYP3A4 or CYP2D6 metabolic enzymes within 1 week prior to Day 1 and during the overall study period.

  14. Use of any drugs or substances known to be strong inhibitors of CYP3A4 or CYP2D6 enzymes within 1 week prior to Day 1 or planned to be used during the overall study period.

  15. Use of any drugs or substances known to be CYP3A4 substrates with narrow therapeutic range within 1 week prior to Day 1 or planned to be used during the overall study period.

  16. Use of any drugs or substances known to be strong inducers of CYP3A4 or CYP2D6 enzymes within 4 weeks prior to Day 1 or planned to be used during the overall study period.

  17. Lactating female patient.

  18. Enrolment in a previous study on netupitant (either administered alone or in combination with palonosetron).

  19. Marked baseline prolongation of QTc interval (QTcF>460 millisecond [msec]). At the discretion of the investigator, criterion may be based on automatic interpretation of results.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 방지
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: IV NEPA

The Test Treatment (IV NEPA) is planned to be administered in Cohort 1 and Cohort 2.

IV NEPA Dosing Schedule

  • Cohort 1 (single-day HEC): Single 30-min infusion on Day 1, before start of chemotherapy.
  • Cohort 2 (multi-day HEC): Single 30-min infusion on Days 1, 3, and 5 (administration on Day 5 depending on the patient's multi day HEC scheme), before start of chemotherapy or in the morning if no chemotherapy is administered on the same day.
의약품: IV NEPA (fosnetupitant/palonosetron)

In NEPA-22-01, different body weight-based dosages of IV NEPA will be applied to patients below and over 3 months of age:

Formulation A (for patients ≥3 months of age; 235 mg fosnetupitant/1.5 mg palonosetron per vial) or Formulation B (for patients <3 months of age; 235 mg fosnetupitant/2.5 mg palonosetron per vial).
활성 비교기: Reference Treatment

The Reference Treatment is planned to be administered in Cohort 1 only. The Reference Treatment includes fosaprepitant powder for solution for IV infusion and ondansetron liquid solution for IV infusion.
의약품: Reference Treatment: IV ondansetron infusion

IV Ondansetron Dosing Regimen

  • Day 1 (before start of chemotherapy): One 30-min infusion of 0.15 mg/kg (ondansetron maximum dose: 8 mg per administration)
  • Day 1 at 4 h and 8 h after the end of first administration: Two 30-min infusions of 0.15 mg/kg (ondansetron maximum dose: 8 mg per administration)
의약품: Reference Treatment: IV fosaprepitant infusion

Fosaprepitant IV Dosing Regimen

  • Patients aged 12 years to <18 years: a single dose of IV fosaprepitant 150 mg
  • Patients aged 2 years to <12 years: a single dose of IV fosaprepitant 4 mg/kg (maximum dose: 150 mg)
  • Patients aged 6 months to <2 years: a single dose of IV fosaprepitant 5 mg/kg (maximum dose: 150 mg)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
COHORT 1 Neptupitant exposure parameter
기간: From time zero ( start of IV NEPA infusion) to maximum 168 hours

Maximum concentration (Cmax)
From time zero ( start of IV NEPA infusion) to maximum 168 hours
COHORT 1 Neptupitant exposure
기간: From time zero ( start of IV NEPA infusion) to maximum 168 hours

Area under the plasma concentration-time curve
From time zero ( start of IV NEPA infusion) to maximum 168 hours
COHORT 2 monitoring of AEs (safety and tolerability of IV NEPA)
기간: Up to 31 days

monitoring of AEs following repeated IV NEPA administration
Up to 31 days

2차 결과 측정

결과 측정
측정값 설명
기간
COHORT 1: To assess the PK profile of netupitant.
기간: From Time zero ( start of IV NEPA infusion) until 168 hours

Cmax of netupitant
From Time zero ( start of IV NEPA infusion) until 168 hours
COHORT 1: To assess the PK profile of fosnetupitant.
기간: From Time zero ( start of IV NEPA infusion) until 168 hours

Cmax of fosnetupitant
From Time zero ( start of IV NEPA infusion) until 168 hours
COHORT 1: To assess the PK profile palonosetron.
기간: From Time zero ( start of IV NEPA infusion) until 168 hours

Cmax of palonosetron
From Time zero ( start of IV NEPA infusion) until 168 hours
COHORT 1: To assess the PK profile of netupitant
기간: From Time zero ( start of IV NEPA infusion) until 48 hours

AUC0-48 of netupitant
From Time zero ( start of IV NEPA infusion) until 48 hours
COHORT 1: To assess the PK profile of fosnetupitant.
기간: From Time zero ( start of IV NEPA infusion) until 48 hours

AUC0-48 of fosnetupitant
From Time zero ( start of IV NEPA infusion) until 48 hours
COHORT 1: To assess the PK profile palonosetron.
기간: From Time zero ( start of IV NEPA infusion) until 48 hours

AUC0-48 of palonosetron
From Time zero ( start of IV NEPA infusion) until 48 hours
COHORT 1: To assess the PK profile of netupitant
기간: From Time zero ( start of IV NEPA infusion) until 168 hours

t1/2 of netupitant
From Time zero ( start of IV NEPA infusion) until 168 hours
COHORT 1: To assess the PK profile of palonosetron.
기간: From Time zero ( start of IV NEPA infusion) until 168 hours

t1/2 of palonosetron
From Time zero ( start of IV NEPA infusion) until 168 hours
COHORT 1 and 2: To assess the population PK profile of fosnetupitant.
기간: From Time zero ( start of IV NEPA infusion) until 168 hours

Clearance (CL) of fosnetupitant
From Time zero ( start of IV NEPA infusion) until 168 hours
COHORT 1 and 2: To assess the population PK profile of palonosetron.
기간: From Time zero ( start of IV NEPA infusion) until 168 hours

CL of palonosetron
From Time zero ( start of IV NEPA infusion) until 168 hours
COHORT 1 and 2: To assess the population PK profile of netupitant.
기간: From Time zero ( start of IV NEPA infusion) until 168 hours

CL/F of netupitant
From Time zero ( start of IV NEPA infusion) until 168 hours
COHORT 1 and 2: To assess the population PK profile of fosnetupitant
기간: From Time zero ( start of IV NEPA infusion) until 168 hours

Volume of compartments (V) for fosnetupitant
From Time zero ( start of IV NEPA infusion) until 168 hours
COHORT 1 and 2: To assess the population PK profile of palonosetron.
기간: From Time zero ( start of IV NEPA infusion) until 168 hours

V for palonosetron
From Time zero ( start of IV NEPA infusion) until 168 hours
COHORT 1 and 2: To assess the population PK profile of netupitant.
기간: From Time zero ( start of IV NEPA infusion) until 168 hours

V/F for netupitant
From Time zero ( start of IV NEPA infusion) until 168 hours

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Helsinn Healthcare SA

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 7월 7일

기본 완료 (추정된)

2027년 10월 1일

연구 완료 (추정된)

2027년 12월 1일

연구 등록 날짜

최초 제출

2024년 12월 16일

QC 기준을 충족하는 최초 제출

2025년 3월 31일

처음 게시됨 (실제)

2025년 4월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 28일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NEPA-22-01
  • 2024-514321-39 (EudraCT 번호)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Only global trial data will be shared, not a single patient

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다