Phase 1 Study of ATR-101 in Subjects With Advanced Adrenocortical Carcinoma

Status:	Completed
Conditions:	Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	11/8/2017
Start Date:	August 13, 2013
End Date:	October 17, 2017

Phase 1 Study of the Safety and Tolerability of ATR-101 in Adrenocortical Carcinoma

This first-in-human study is designed to establish the safety and tolerability of ATR-101 in
patients with advanced adrenocortical carcinoma whose tumor has progressed on standard
therapy. Information will also be collected to determine how long ATR-101 stays in the blood,
and if any effect on tumor progression is seen. Biomarkers (blood and urine tests) will
determine if any effects on production of steroid hormones (cortisol, aldosterone, estrogen
and testosterone) are seen.

Inclusion Criteria:

18 years;

- Clinical confirmation of adrenocortical carcinoma that is locally advanced or
metastatic and not amendable to surgical resection;

- Failed or declined mitotane (adjuvant or therapeutic) therapy or a platinum-based
chemotherapy regimen;

- Able to understand and comply with the protocol requirements;

- Willing and able to provide informed consent.

Exclusion Criteria:

- Mitotane level > 5

- Use of contraindicated concomitant medications

- Unstable medical condition that, in the judgment of the investigator, could interfere
with study procedures or data interpretation.

We found this trial at

sites

M.D.Anderson Cancer Center

Houston, Texas 77030

Principal Investigator: Aung Naing, MD

Phone: 713-563-1930

from

Houston, TX