A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy
Start Date
5/20/2021
Completion Date
10/1/2027
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.
Detailed 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 Criteria
Age Range: No minimum to 17 years
Interventions
Eflapegrastim
Chemotherapy
Conditions
Locations
New York Medical College
Valhalla, New York 10595
United States
Carolinas Medical Center/ Levine Children's Hospital
Charlotte, North Carolina 28203
United States
Levine Children's Health
Charlotte, North Carolina 28203
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
UT MD Anderson Cancer Center
Houston, Texas 77030
United States