A Phase 1 Study of XL184 (Cabozantinib, IND# 116059) in Children and Adolescents With Recurrent or Refractory Solid Tumors, Including CNS Tumors

Status
Active
Cancer Type
Unknown Primary
Trial Phase
Phase I
Eligibility
2 to 18, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCD ID
NCT01709435
Protocol IDs
NCI-2012-01890 (primary)
ADVL1211
U01CA097452
Study Sponsor
National Cancer Institute

Summary

This phase I trial studies the side effects and best dose of cabozantinib in treating younger patients with recurrent or refractory solid tumors. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Objectives

PRIMARY OBJECTIVES:

I. To estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose of XL184 (cabozantinib) administered orally every day to children with refractory solid tumors including central nervous system (CNS) tumors.

II. To define and describe the toxicities of XL184 (cabozantinib) administered on this schedule.

III. To characterize the pharmacokinetics of XL184 (cabozantinib) in children with refractory solid tumors.

SECONDARY OBJECTIVES:

I. To preliminarily define the antitumor activity of XL184 (cabozantinib) within the confines of a Phase 1 study.

II. To assess the biologic activity of XL184 (cabozantinib). III. To assess the biomarker response (carcinoembryonic antigen [CEA] and calcitonin) in patients with medullary thyroid cancer treated with XL184.

OUTLINE: This is a dose-escalation study.

Patients receive cabozantinib orally (PO) once daily (QD) on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Treatment Sites in Georgia


Aflac Cancer and Blood Disorders Center of Children’s at Egleston
1405 Clifton Road NE
3rd Floor
Atlanta, GA 30322
404-785-0853
www.choa.org