Phase 1 Study of ATR-101 in Subjects With Advanced 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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 1 Study of the Safety and Tolerability of ATR-101 in Adrenocortical Carcinoma|
- Frequency of dose-limiting toxicity and determination of maximum tolerated dose [ Time Frame: Occurrence of DLT at 28 days ] [ Designated as safety issue: Yes ]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.
- Area under the plasma concentration versus time curve (AUC) of ATR-101 [ Time Frame: Day 1 and Day 22 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- Change in objective measurement of tumor size [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]CT or MRI scans will be read according to RECIST 1.1
|Study Start Date:||July 2013|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
ATR-101 will be administered as capsules by mouth once per day to ascending dose cohorts
|Contact: Marian Ijzerman, PhD||734-845-9300|
|Contact: Martin D Phillips, MD||734-845-9000|
|United States, Michigan|
|University of Michigan Cancer Center||Recruiting|
|Ann Arbor, Michigan, United States, 48103|
|United States, Texas|
|MDAnderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|