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 on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Lymphoma
- Solid Tumors
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 117 years
- Gender
- Both males and females
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-li...
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.
Tracking Information
- NCT #
- NCT04570423
- Collaborators
- Not Provided
- Investigators
- Not Provided