Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2025-12-24 @ 10:18 PM
NCT ID:
NCT01709435
Brief 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.
Study:
NCT01709435
Study Brief:
Protocol Section:
NCT01709435