NCT01709435

Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects and best dose of cabozantinib S-malate in treating younger patients with solid tumors that have come back or no longer respond to treatment. Cabozantinib S-malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose of XL184 (cabozantinib) (cabozantinib S-malate) administered orally 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. IV. To evaluate overall survival from study entry through a five-year follow-up period. OUTLINE: This is a dose-escalation study. (Complete as of 4/16/2014) Patients receive cabozantinib S-malate orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, 6 months, and then annually for up to 60 months.

Conditions

• Recurrent Malignant Solid Neoplasm
• Recurrent Melanoma
• Recurrent Primary Central Nervous System Neoplasm
• Recurrent Thyroid Gland Carcinoma
• Refractory Malignant Solid Neoplasm
• Refractory Primary Central Nervous System Neoplasm
• Thyroid Gland Medullary Carcinoma

Interventions

Type	Name	Description
DRUG	Cabozantinib S-malate	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2012-11-14
• Primary completion: 2018-12-31
• Completion: 2019-12-31
• First posted: 2012-10-18
• Last updated: 2023-12-22
• Results posted: 2023-12-21

Locations

23 sites across 2 countries: United States, Canada