Phase 1 Study of ATR-101 in Subjects With Advanced Adrenocortical Carcinoma

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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

, , 

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

, , 


Verification Date

November 2017