NCT01538095

Trebananib in Treating Younger Patients With Relapsed or Refractory Solid Tumors, Including Central Nervous System Tumors

A Phase 1 Study of AMG 386, an Angiopoietin Neutralizing Peptibody, in Children With Relapsed or Refractory Solid Tumors, Including CNS Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 2 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of trebananib in treating patients with solid tumors that has returned after a period of improvement or does not respond to treatment, including central nervous system tumors. Trebananib may stop the growth of tumor cells by blocking blood flow to the tumor.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the maximum-tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of trebananib (AMG 386) administered as a weekly intravenous infusion to children with recurrent or refractory solid tumors. II. To determine the tolerability of the solid tumor MTD and/or RP2D of AMG 386 in children with central nervous system (CNS) tumors. III. To define and describe the toxicities of AMG 386 administered on this schedule. IV. To characterize the pharmacokinetics and immunogenicity of AMG 386 in children with refractory cancer. V. To measure changes in vascular permeability relative to baseline, evaluated by magnetic resonance imaging (MRI) perfusion, following AMG 386 administration in pediatric patients with CNS tumors. SECONDARY OBJECTIVES: I. To preliminarily define the antitumor activity of AMG 386 within the confines of a Phase 1 study. II. To measure biologic markers of angiogenesis with potential for correlation with disease response. OUTLINE: This is a dose-escalation study (part 1) followed by a safety and imaging study (part 2). Patients receive trebananib intravenously (IV) over 30-60 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 3 to 6 months for up to 1 year.

Conditions

• Central Nervous System Neoplasm
• Solid Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Dynamic Contrast-Enhanced Magnetic Resonance Imaging	Correlative studies
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
BIOLOGICAL	Trebananib	Given IV

Timeline

• Start date: 2012-02-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2012-02-23
• Last updated: 2016-10-03

Locations

22 sites across 2 countries: United States, Canada