Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors
|ClinicalTrials.gov Identifier: NCT01709435|
Recruitment Status : Active, not recruiting
First Posted : October 18, 2012
Last Update Posted : March 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Childhood Solid Neoplasm Childhood Thyroid Gland Medullary Carcinoma Recurrent Childhood Central Nervous System Neoplasm Recurrent Malignant Solid Neoplasm Recurrent Melanoma Recurrent Thyroid Gland Carcinoma Refractory Malignant Solid Neoplasm||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)|
|Estimated 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|
|Estimated Primary Completion Date :||October 31, 2018|
|Estimated Study Completion Date :||October 31, 2018|
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 Names:Other: Laboratory Biomarker Analysis
Correlative studiesOther: Pharmacological Study
- Maximum tolerated dose (MTD) and/or recommended phase 2 dose of cabozantinib S-malate, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: 28 days ]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 assessed according to Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to 5 years ]Will be reported descriptively.
- Overall survival (OS) [ Time Frame: Up to 5 years ]OS will also be assessed and summarized using the Kaplan-Meier method.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709435
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|Principal Investigator:||Meredith Chuk||COG Phase I Consortium|