A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy

Официальное название

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Patients With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy

Обзор

The purpose of this study is to evaluate the safety and pharmacokinetics of eflapegrastim in pediatric participants with solid tumors or lymphoma and treated with myelosuppressive chemotherapy.

Подробное описание

This is a Phase 2, open label, multicenter study of eflapegrastim in pediatric participants (≥1 month to \<17 years) with solid tumors or lymphoma.

Approximately 40 participants will be enrolled and assigned to one of 4 age-based cohorts. Participants enrolled in Cohort 1 will be followed for dose-limiting toxicities (DLTs) prior to initiating parallel enrollment into Cohorts 2 through 4.

All participants will receive chemotherapy as Standard of Care after which a subcutaneous (SC) dose of eflapegrastim will be administered up to 4 treatment cycles.

Вмешательства

• Препарат Eflapegrastim
  Eflapegrastim supplied in prefilled, single-use syringes for SC injection.
• Препарат Chemotherapy
  Chemotherapy agents may include doxorubicin, ifosfamide, docetaxel, CHOP regimen, etoposide, cyclophosphamide and vincristine which will be administered as per standard of care per the Primary Care physician's treatment plan.

Первичные конечные точки

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Срок оценки: From first dose of study drug to 35 days after the last dose of the study drug (Up to approximately 16 months)]

Вторичные конечные точки (6)

• Percentage of Participants With Severe Neutropenia in Cycle 1 [Срок оценки: Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected)]
• Time to Absolute Neutrophil Count (ANC) Recovery of Severe Neutropenia in Cycle 1 [Срок оценки: Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected)]
• Number of Participants With Febrile Neutropenia in Cycle 1 [Срок оценки: Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected)]
• Peak Concentration (Cmax) of Eflapegrastim in Cycle 1 [Срок оценки: Pre-dose and at multiple time points (up to Day 9 [Cohorts 1-3] and Day 6 [Cohort 4]) post-dose in Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected)]
• Time to Reach Peak Concentration (Tmax) of Eflapegrastim in Cycle 1 [Срок оценки: Pre-dose and at multiple time points (up to Day 9 [Cohorts 1-3] and Day 6 [Cohort 4]) post-dose in Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected)]
• Elimination Half-life (t½) of Eflapegrastim in Cycle 1 [Срок оценки: Pre-dose and at multiple time points (up to Day 9 [Cohorts 1-3] and Day 6 [Cohort 4]) post-dose in Cycle 1 (cycle length may vary and can be up to 28 days or more based on the type of chemotherapy selected)]

Критерии участия

Критерии включения

• Participant must have a pathologic/histologic confirmed newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement.
• Participant must be a candidate to receive myelosuppressive chemotherapy, with a febrile neutropenia rate of at least 20% as outlined in the National Comprehensive Cancer Network (NCCN) guidelines.
• Participant has adequate hematological, renal, and hepatic function.
• Participant must have an echocardiogram (ECHO) or multigated acquisition (MUGA) within 14 days of Screening if receiving a cardiotoxic therapy and have a cardiac ejection fraction of >50%.
• Participant must have a lumbar puncture, if clinically indicated, to rule out central nervous system (CNS) involvement within 14 days of study entry.
• Participant has a Karnofsky performance level ≥50% for patients ≥16 years of age or a Lansky performance level ≥50 for children <16 years of age.

Критерии исключения

• Participant has an uncontrollable infection, has an underlying medical condition, and/or another serious illness that would impair the ability of the participant to receive protocol-specified treatment.
• Participant has had previous exposure to filgrastim (within 7 days), pegfilgrastim (within 14 days), or other granulocyte colony stimulating factor (G-CSF) products in clinical development within 2 weeks prior to the administration of study drug (eflapegrastim)
• Participant requires concurrent radiation therapy specifically in Cycle 1.
• Participant has had prior bone marrow or hematopoietic stem cell transplant and/or has concurrent bone marrow involvement in their malignancy, including leukemia.
• Participant has had spinal radiation therapy within 30 days prior to study enrollment.
• Participant has used any investigational drugs, biologics or devices within 30 days prior to study treatment or plans to use any of these during the study.
• Participant has a known sensitivity or previous reactions to any of the G-CSF products.
• Participant with active CNS disease.
• Participant has not recovered from previous treatment adverse events to ≤Grade 1.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 5 центров

• New York Medical College — Valhalla
• Carolinas Medical Center/ Levine Children's Hospital — Charlotte
• Levine Children's Health — Charlotte
• University Hospitals Cleveland Medical Center — Cleveland
• UT MD Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT04570423 · SPI-GCF-202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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