Trial | NCT01898715  Report issue

Title

Phase 1 Study of ATR-101 in Subjects With Advanced Adrenocortical Carcinoma
Phase 1 Study of the Safety and Tolerability of ATR-101 in Adrenocortical Carcinoma

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    atr-101 ...

  • Study Participants

    63
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 Started
Aug 13
2013
Primary Completion
Nov 02
2016
Study Completion
Oct 17
2017
Last Update
Nov 06
2017

Drug ATR-101

ATR-101 Experimental

ATR-101 will be administered as capsules or tablets by mouth once or twice per day to ascending dose cohorts

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.
No Results Posted