A Phase 1 Study Of Ramucirumab a Human Monoclonal Antibody Against the Vascular Endothelial Growth Factor-2 (VEGFR-2) Receptor in Children With Refractory Solid Tumors Including CNS Tumors

J
James Croop, MD, PhD

Primary Investigator

Overview

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.

Description

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.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Solid Tumor,Cancer,solid tumors
  • Age: Between 1 Years - 21 Years
  • Gender: All

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


Additional Information:
Participants will not be paid for their participation.

Updated on 09 Mar 2024. Study ID: 1511807264 (PHO-LILLY-CROOP-ADVL1416)

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