A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors

• Status: Completed
• Trial end date: 2019-07-16
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to evaluate the safety of the study drug known as ramucirumab in children with recurrent or refractory solid tumors including central nervous system (CNS) tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Collaborator: Children's Oncology Group
• Treatments: Endothelial Growth Factors; Ramucirumab

Criteria

Inclusion Criteria:

• Part A: participants with recurrent or refractory non-CNS solid tumors

• Part B: participants with recurrent or refractory CNS tumors

• Measurable or evaluable disease

• No other therapeutic options

• Performance Status: Karnofsky ≥50% for participants >16 years and Lansky ≥50 for participants ≤16 years

Exclusion Criteria:

• Active or recent history of serious bleeding events

• Active or recent history of gastrointestinal perforations, ulcers, fistulas or abscesses

• Active or recent history of hypertensive crisis or hypertensive encephalopathy

• Active non-healing wound or bone fracture

• History of solid organ transplant