Brief Title
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
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Frequency of dose-limiting toxicity and determination of maximum tolerated dose
Secondary Outcome
Area under the plasma concentration versus time curve (AUC) of ATR-101
Condition
Adrenocortical Carcinoma
Intervention
ATR-101
Study Arms / Comparison Groups
ATR-101
Description: ATR-101 will be administered as capsules or tablets by mouth once or twice per day to ascending dose cohorts
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
63
Start Date
August 13, 2013
Completion Date
October 17, 2017
Primary Completion Date
November 2, 2016
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT01898715
Organization ID
ATR-101-001
Responsible Party
Sponsor
Study Sponsor
Millendo Therapeutics, Inc.
Study Sponsor
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Verification Date
November 2017