Phase 1 Study of ATR-101 in Subjects With Advanced Adrenocortical Carcinoma
NCT ID: NCT01898715
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
63 participants
INTERVENTIONAL
2013-08-13
2017-10-17
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ATR-101
ATR-101 will be administered as capsules or tablets by mouth once or twice per day to ascending dose cohorts
ATR-101
Interventions
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ATR-101
Eligibility Criteria
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Inclusion Criteria
* 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
* Use of contraindicated concomitant medications
* Unstable medical condition that, in the judgment of the investigator, could interfere with study procedures or data interpretation.
18 Years
ALL
No
Sponsors
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Millendo Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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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.
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.
Other Identifiers
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ATR-101-001
Identifier Type: -
Identifier Source: org_study_id