A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors
Purpose
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.
Conditions
- Pediatric Solid Tumor
- Refractory Tumor
- Recurrent Tumor
- CNS Malignancies
Eligibility
- Eligible Ages
- Between 12 Months and 21 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Ramucirumab |
(Part A-Non-CNS Solid Tumors) Escalating doses of 8 milligrams per kilogram (mg/kg) or 12 mg/kg Ramucirumab administered as an intravenous infusion every 2 weeks (Q2W) with 3 doses per 42 day cycle. (Part B-CNS Tumors) Participants received 12 mg/kg Ramucirumab as an intravenous injection Q2W with 3 doses per cycle. |
|
Recruiting Locations
More Details
- NCT ID
- NCT02564198
- Status
- Completed
- Sponsor
- Eli Lilly and Company