Cabozantinib in Unresectable/Metastatic Adrenocortical Carcinoma
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|ClinicalTrials.gov Identifier: NCT03370718|
Recruitment Status : Recruiting
First Posted : December 12, 2017
Last Update Posted : May 8, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Adrenocortical Carcinoma||Drug: Cabozantinib||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study to Evaluate the Effects of Cabozantinib in Patients With Unresectable/Metastatic Adrenocortical Carcinoma|
|Actual Study Start Date :||February 26, 2018|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2021|
Participants take Cabozantinib tablets by mouth 1 time each day.
Cabozantinib initiation dose is 60 mg daily by mouth. The dose can be reduced to 40 mg then 20 mg a day based on tolerability and adverse effects.
- Progression-Free Survival Rate (PFS) in Patients with Unresectable/Metastatic Adrenocortical Carcinoma (ACC) Who Receive Cabozantinib [ Time Frame: 4 months ]PFS determined by serial imaging studies used to assess measurable disease per RECIST 1.1.
- Toxicity in Patients with Unresectable/Metastatic Adrenocortical Carcinoma (ACC) Who Receive Cabozantinib [ Time Frame: 4 months ]Toxicity defined as any grade ≥ 3 toxicity that is attributed to cabozantinib as defined by Common Terminology Criteria for Adverse Events (CTCAE) V4.0
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03370718
|Contact: Mouhammed A. Habra, MD||713-792-2841||CR_Study_Registration@mdanderson.org|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Clinical Research Operations CR_Study_Registration@mdanderson.org|
|Principal Investigator:||Mouhammed A. Habra, MD||M.D. Anderson Cancer Center|