Last updated on May 2019

Cabozantinib in Treating Patients With Locally Advanced or Metastatic Unresectable Adrenocortical Carcinoma


Brief description of study

This phase II trial studies how well cabozantinib works in treating patients with adrenal cortex cancer that has spread to nearby tissue, lymph nodes, or other places in the body, and cannot be removed by surgery. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed Study Description

PRIMARY OBJECTIVES:

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.

Clinical Study Identifier: NCT03370718

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