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
Spectrum Pharmaceuticals, Inc
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.
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.
Eligibility
- Age range
- 0–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant must have a pathologic/histologic confirmed newly diagnosed/relapsed/recurrent solid tumor or lymphoma without bone marrow involvement. 2. 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. 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…
Interventions
- DrugEflapegrastim
Eflapegrastim supplied in prefilled, single-use syringes for SC injection.
- DrugChemotherapy
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.
Locations (5)
- New York Medical CollegeValhalla, New York
- Carolinas Medical Center/ Levine Children's HospitalCharlotte, North Carolina
- Levine Children's HealthCharlotte, North Carolina
- University Hospitals Cleveland Medical CenterCleveland, Ohio
- UT MD Anderson Cancer CenterHouston, Texas