NCT04570423

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Spectrum Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumors
• Lymphoma

Interventions

Type	Name	Description
DRUG	Eflapegrastim	Eflapegrastim supplied in prefilled, single-use syringes for SC injection.
DRUG	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.

Timeline

• Start date: 2021-05-20
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2020-09-30
• Last updated: 2026-02-18

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study