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

Lilly

Status and phase: Completed; Phase 1

Conditions: Pediatric Solid Tumor; CNS Malignancies; Refractory Tumor; Recurrent Tumor

Treatments: Drug: Ramucirumab

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT02564198

15542

I4T-MC-JVDA (Other Identifier)

ADVL1416 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 12 months to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Ramucirumab

Experimental group

Description:

(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.

Treatment:

Drug: Ramucirumab