Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-20 @ 1:38 PM
Study NCT ID:
NCT03370718
Status:
COMPLETED
Last Update Posted:
2024-12-10
First Post:
2017-12-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cabozantinib in Treating Patients With Locally Advanced or Metastatic Unresectable Adrenocortical Carcinoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Phase II Study to Evaluate the Effects of Cabozantinib in Patients With Unresectable/Metastatic Adrenocortical Carcinoma
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial studies how well cabozantinib works in treating patients with adrenal cortex cancer that has spread to nearby tissue, lymph nodes (locally advanced), or other places in the body (metastatic), and cannot be removed by surgery (unresectable). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description:
PRIMARY OBJECTIVE:
I. To estimate progression free survival at 4 months.
SECONDARY OBJECTIVES:
I. Best overall response rate. II. Overall survival (OS). III. Toxicity assessment by the Common Terminology Criteria for Adverse Events (CTCAE) version (V)4.0.
EXPLORATORY OBJECTIVES:
I. Pharmacokinetics and cabozantinib serum levels to assess correlation with response to therapy.
II. Steroid hormone biomarkers as markers of disease response. III. Study the effect of cabozantinib on immune markers by obtaining optional biopsy and blood samples collections at baseline, during therapy and at time of progression.
IV. Pharmacogenomics of drug disposition gene variants that potentially influence cabozantinib pharmacokinetics (PK).
OUTLINE:
Patients receive cabozantinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30-37 days.
I. To estimate progression free survival at 4 months.
SECONDARY OBJECTIVES:
I. Best overall response rate. II. Overall survival (OS). III. Toxicity assessment by the Common Terminology Criteria for Adverse Events (CTCAE) version (V)4.0.
EXPLORATORY OBJECTIVES:
I. Pharmacokinetics and cabozantinib serum levels to assess correlation with response to therapy.
II. Steroid hormone biomarkers as markers of disease response. III. Study the effect of cabozantinib on immune markers by obtaining optional biopsy and blood samples collections at baseline, during therapy and at time of progression.
IV. Pharmacogenomics of drug disposition gene variants that potentially influence cabozantinib pharmacokinetics (PK).
OUTLINE:
Patients receive cabozantinib orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30-37 days.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: