Ignite Creation Date:
2025-12-24 @ 10:18 PM
Ignite Modification Date:
2025-12-26 @ 10:55 PM
Study NCT ID:
NCT01709435
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2012-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase 1 Study of XL184 (Cabozantinib) in Children and Adolescents With Recurrent or Refractory Solid Tumors, Including CNS Tumors
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-01890 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| P121149 | None | None | View | |
| COG-ADVL1211 | None | None | View | |
| NCI-2013-01571 | None | None | View | |
| CDR0000741914 | None | None | View | |
| ADVL1211 | OTHER | Pediatric Early Phase Clinical Trial Network | View | |
| ADVL1211 | OTHER | CTEP | View | |
| UM1CA097452 | NIH | None | https://reporter.nih.gov/quic… | View |