Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors
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|ClinicalTrials.gov Identifier: NCT01709435|
Recruitment Status : Completed
First Posted : October 18, 2012
Last Update Posted : April 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Cabozantinib S-malate Other: Laboratory Biomarker Analysis Other: Pharmacological Study||Phase 1|
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.
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of XL184 (Cabozantinib) in Children and Adolescents With Recurrent or Refractory Solid Tumors, Including CNS Tumors|
|Actual Study Start Date :||November 14, 2012|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||December 31, 2019|
Experimental: Treatment (cabozantinib S-malate)
Patients receive cabozantinib S-malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Cabozantinib S-malate
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- Maximum tolerated dose (MTD) and/or recommended phase 2 dose of cabozantinib S-malate [ Time Frame: 28 days ]Will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. In addition to determination of the MTD, a descriptive summary of all toxicities will be reported.
- Pharmacokinetic (PK) parameters of cabozantinib S-malate including systemic exposure and drug clearance [ Time Frame: Course 1, day 1 (pre-dose and 4 hours post dose), course 1 day 21 (+/- 2 days) (pre-dose, 2, 4, 8 and 24 hours post dose), course 3 day 1 (pre-dose) ]Will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit). PK parameters will be summarized with simple summary statistics, including means, medians, ranges, and standard deviations (if numbers and distribution permit).
- Disease response [ Time Frame: Up to 5 years ]Will be assessed according to Response Evaluation Criteria in Solid Tumors 1.1 criteria and reported descriptively.
- Overall survival (OS) [ Time Frame: Up to 5 years ]OS will also be assessed and summarized using the Kaplan-Meier method.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709435
|Principal Investigator:||Meredith K Chuk||COG Phase I Consortium|