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

Phase 1

• Conditions: Pediatric Solid TumorCNS Malignancies; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-000364-30-Outside-EU/EEA
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-01
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 1. Baseline to Study Completion (Approximately 42 Months)<br><br>2. Predose Cycle 1 Day 1 through Follow-Up (Approximately 6 Months)<br><br>3.Predose Cycle 1 Day 1 through Follow-Up (Approximately 42 Months);Main Objective: 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.;Secondary Objective: Not applicable;Primary end point(s): 1. Maximum Tolerated Dose of Ramucirumab <br><br>2. Pharmacokinetics (PK): Minimum Concentration (Cmin) of Ramucirumab<br><br>3. Number of Participants with Anti-Ramucirumab Antibodies

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Percentage of Participants with Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD): Best Overall Response (BOR) ;Timepoint(s) of evaluation of this end point: Baseline to Date of Objective Disease Progression (Approximately 42 Months)