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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Millendo Therapeutics, Inc.

Current Primary Outcome: Frequency of dose-limiting toxicity and determination of maximum tolerated dose [ Time Frame: Occurrence of DLT at 28 days ]

Adverse events will be recorded and tabulated by grade and system organ class according to CTCAE v 4.03. Laboratory measures and ECGs will be assessed.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Area under the plasma concentration versus time curve (AUC) of ATR-101 [ Time Frame: Day 1 and Day 22 ]
    Plasma levels of ATR-101 will be assessed after daily oral dosing and pharmacokinetic parameters will be calculated.
  • Change in plasma cortisol levels [ Time Frame: Baseline and day 22 ]
  • Change in objective measurement of tumor size [ Time Frame: Baseline and 8 weeks ]
    CT or MRI scans will be read according to RECIST 1.1


Original Secondary Outcome: Same as current

Information By: Millendo Therapeutics, Inc.

Dates:
Date Received: July 10, 2013
Date Started: July 2013
Date Completion: July 2019
Last Updated: February 6, 2017
Last Verified: February 2017