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

Completed · Phase 1

Conditions studied: Adrenocortical Carcinoma, Adrenal Cancer, ACC

In brief

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.

Key facts

Study ID

NCT01898715

Run by

Millendo Therapeutics, Inc.

People needed

63

Starts

2013-08-13

Expected to finish

2017-10-17

Last updated by the study team

2017-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Moffitt Cancer Center — Tampa, Florida, United States
• National Institutes of Health/National Cancer Institute — Bethesda, Maryland, United States
• University of Michigan Cancer Center — Ann Arbor, Michigan, United States
• MDAnderson Cancer Center — Houston, Texas, United States
• Comprehensive Cancer Center Mainfranken, University Hospital of Würzburg — Würzburg, Germany

Full record on ClinicalTrials.gov

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