A Phase 1 interventional study of ATR-101 in Adrenocortical Carcinoma, Adrenal Cancer and ACC, sponsored by Millendo Therapeutics, Inc.. Completed at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by Millendo Therapeutics, Inc. · Phase 1, Interventional, and Treatment
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.
94 studies on the registry are indexed under Adrenocortical Carcinoma; 26 are open to participants now.
This study's enrollment of 63 is above the median of 30 across 69 interventional studies indexed under Adrenocortical Carcinoma.
Browse Adrenocortical Carcinoma studies →Millendo Therapeutics, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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18 years;
Exclusion Criteria:
ATR-101 will be administered as capsules or tablets by mouth once or twice per day to ascending dose cohorts
Drug: ATR-101
Frequency of dose-limiting toxicity and determination of maximum tolerated dose
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.
Time frame: Occurrence of DLT at 28 days
Area under the plasma concentration versus time curve (AUC) of ATR-101
Plasma levels of ATR-101 will be assessed after daily oral dosing and pharmacokinetic parameters will be calculated.
Time frame: Day 1 and Day 22
Change in plasma cortisol levels
Time frame: Baseline and day 22
Change in objective measurement of tumor size
CT or MRI scans will be read according to RECIST 1.1
Time frame: Baseline and 8 weeks
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pd-132301 hydrochloride
Millendo Therapeutics, Inc.