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

Last updated: April 24, 2025
Sponsor: Spectrum Pharmaceuticals, Inc
Overall Status: Active - Recruiting

Phase

2

Condition

Solid Tumors

Lymphoma

Treatment

Eflapegrastim

Chemotherapy

Clinical Study ID

NCT04570423
SPI-GCF-202
  • Ages 1-17
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant must have a pathologic/histologic confirmed newlydiagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrowinvolvement.

  2. Participant must be a candidate to receive myelosuppressive chemotherapy, with afebrile neutropenia rate of at least 20% as outlined in the National ComprehensiveCancer Network (NCCN) guidelines.

  3. Participant has adequate hematological, renal, and hepatic function.

  4. Participant must have an echocardiogram (ECHO) or multigated acquisition (MUGA)within 14 days of Screening if receiving a cardiotoxic therapy and have a cardiacejection fraction of >50%.

  5. Participant must have a lumbar puncture, if clinically indicated, to rule outcentral nervous system (CNS) involvement within 14 days of study entry.

  6. Participant has a Karnofsky performance level ≥50% for patients ≥16 years of age ora Lansky performance level ≥50 for children <16 years of age.

Exclusion

Exclusion Criteria:

  1. Participant has an uncontrollable infection, has an underlying medical condition,and/or another serious illness that would impair the ability of the participant toreceive protocol-specified treatment.

  2. Participant has had previous exposure to filgrastim (within 7 days), pegfilgrastim (within 14 days), or other granulocyte colony stimulating factor (G-CSF) products inclinical development within 2 weeks prior to the administration of study drug (eflapegrastim)

  3. Participant requires concurrent radiation therapy specifically in Cycle 1.

  4. Participant has had prior bone marrow or hematopoietic stem cell transplant and/orhas concurrent bone marrow involvement in their malignancy, including leukemia.

  5. Participant has had spinal radiation therapy within 30 days prior to studyenrollment.

  6. Participant has used any investigational drugs, biologics or devices within 30 daysprior to study treatment or plans to use any of these during the study.

  7. Participant has a known sensitivity or previous reactions to any of the G-CSFproducts.

  8. Participant with active CNS disease.

  9. Participant has not recovered from previous treatment adverse events to ≤Grade 1.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Eflapegrastim
Phase: 2
Study Start date:
May 20, 2021
Estimated Completion Date:
October 31, 2027

Study Description

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.

Connect with a study center

  • New York Medical College

    Valhalla, New York 10595
    United States

    Active - Recruiting

  • Carolinas Medical Center/ Levine Children's Hospital

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • Levine Children's Health

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • UT MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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