Last updated on February 2019

Cabozantinib in Unresectable/Metastatic Adrenocortical Carcinoma


Brief description of study

The goal of this clinical research study is to learn if cabozantinib can help to control unresectable (cannot be removed with surgery) or metastatic (has spread) adrenocortical carcinomas. The safety of this drug will also be studied.

This is an investigational study. Cabozantinib is FDA approved and commercially available to treat medullary thyroid cancer and kidney cancer. It is considered investigational to use cabozantinib to treat adrenocortical carcinomas.

The study doctor can explain how cabozantinib is designed to work.

Up to 18 participants will be enrolled in this study. All will take part at MD Anderson.

Detailed Study Description

Study Drug Administration:

If participant is are found to be eligible to take part in this study, participant will take cabozantinib tablets by mouth 1 time each day. Participant should take participant's dose of study drug at about the same time each day with about a cup (8 ounces) of water. Participant should not eat for at least 2 hours before and at least 1 hour after taking participant's dose of study drug. Participant should not crush the tablets.

If participant forgets to take participant's dose of cabozantinib and it has been less than 12 hours since the scheduled dose time, participant should take participant's dose as soon as participant remembers. If it has been more than 12 hours, participant should not take the drug that day, and wait for participant's next scheduled dose.

Length of Study:

Participant may continue to receive cabozantinib for as long as the study doctor thinks it is in participant's best interest. Participant will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if participant is unable to follow study directions.

Participation on the study will be over after the follow-up visit.

Study Visits:

On Day 1:

  • Blood (about 3 tablespoons) will be drawn for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points.
  • If participant can become pregnant, urine may be collected for a pregnancy test.

On Day 1 of Weeks 3 and 5 and then every 4 weeks after that:

  • Participant will have a physical exam.
  • Blood (about 3-4 teaspoons) and urine will be collected for routine tests.
  • Participant will have an EKG. After Week 12, this will be performed every 8 weeks.
  • If participant can become pregnant, urine or part of the above blood sample will be collected for a pregnancy test. After Week 12, this pregnancy test will be performed every 8 weeks.

On Day 29, blood (about 3 tablespoons), and then every 12 weeks after that, blood (about 2 teaspoons), will be drawn for PK testing.

On Day 1 of Week 9, blood (about 3 tablespoons) will be drawn for immune system testing.

Every 8 weeks:

  • Participant will have an MRI, CT, or PET scan to check the status of the disease.
  • If the doctor thinks it is needed, blood (about 3-4 teaspoons) will be drawn to measure participant's hormone levels.

If at any point the disease appears to get worse, blood (about 3 tablespoons) will be drawn for immune system testing.

Follow-Up Visit:

About 30-37 days after participant's last dose of study drug:

  • Participant will have a physical exam.
  • Blood (about 3-4 teaspoons) and urine will be collected for routine tests. If participant can become pregnant, part of this urine or blood sample may be used for a pregnancy test.
  • You will have an EKG.

Clinical Study Identifier: NCT03370718

Contact Investigators or Research Sites near you

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Mouhammed A. Habra, MD

University of Texas MD Anderson Cancer Center
Houston, TX United States
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Recruitment Status: Open


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