Skip to main content
OpenTrials
Completed

NCT Number: NCT01898715

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adrenocortical Carcinoma ACC Adenocarcinoma Adrenal Cancer Adrenal Cortex Diseases Adrenal Cortex Neoplasms Adrenal Gland Diseases Adrenal Gland Neoplasms Carcinoma Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Comprehensive Cancer Center Mainfranken, University Hospital of Würzburg, Würzburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ATR-101

Drug

Primary outcomes

  1. Frequency of dose-limiting toxicity and determination of maximum tolerated dose

    Time frame: Occurrence of DLT at 28 days

    Adverse events will be recorded and tabulated by grade and system organ class according to CTCAE v 4.03. Laboratory measures and ECGs will be assessed.

Secondary outcomes

  1. Area under the plasma concentration versus time curve (AUC) of ATR-101

    Time frame: Day 1 and Day 22

    Plasma levels of ATR-101 will be assessed after daily oral dosing and pharmacokinetic parameters will be calculated.

  2. Change in plasma cortisol levels

    Time frame: Baseline and day 22

  3. Change in objective measurement of tumor size

    Time frame: Baseline and 8 weeks

    CT or MRI scans will be read according to RECIST 1.1

Sponsors and collaborators

Lead sponsor

Millendo Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Jul 12, 2013
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.