Clinical trial NCT01898715: Phase 1 Study of ATR-101 in Subjects With Advanced Adrenocortical Carcinoma
Official title: Phase 1 Study of the Safety and Tolerability of ATR-101 in Adrenocortical Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adrenocortical Carcinoma
Adrenal Cancer
ACC
Keywords: Adrenocortical carcinoma
Adrenal cancer
ACC
Lead sponsor: Millendo Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-12
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of dose-limiting toxicity and determination of maximum tolerated dose
timeFrame: Occurrence of DLT at 28 days
Secondary outcomes:
measure: Area under the plasma concentration versus time curve (AUC) of ATR-101
timeFrame: Day 1 and Day 22
measure: Change in plasma cortisol levels
timeFrame: Baseline and day 22
measure: Change in objective measurement of tumor size
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Bethesda
country: United States
facility: National Institutes of Health/National Cancer Institute
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
city: Houston
country: United States
facility: MDAnderson Cancer Center
state: Texas
city: Würzburg
country: Germany
facility: Comprehensive Cancer Center Mainfranken, University Hospital of Würzburg
Study officials:
References:
citation: Smith DC, Kroiss M, Kebebew E, Habra MA, Chugh R, Schneider BJ, Fassnacht M, Jafarinasabian P, Ijzerman MM, Lin VH, Mohideen P, Naing A. A phase 1 study of nevanimibe HCl, a novel adrenal-specific sterol O-acyltransferase 1 (SOAT1) inhibitor, in adrenocortical carcinoma. Invest New Drugs. 2020 Oct;38(5):1421-1429. doi: 10.1007/s10637-020-00899-1. Epub 2020 Jan 27.
citation: Lalli E, Sasano H. 5th International ACC Symposium: An Outlook to Current and Future Research on the Biology of Adrenocortical Carcinoma: Diagnostic and Therapeutic Applications. Horm Cancer. 2016 Feb;7(1):44-8. doi: 10.1007/s12672-015-0240-3. Epub 2015 Dec 14.