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

This study is currently recruiting participants.
Verified February 2017 by Millendo Therapeutics, Inc.
ClinicalTrials.gov Identifier:
First Posted: July 12, 2013
Last Update Posted: February 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Millendo Therapeutics, Inc.
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.

Condition Intervention Phase
Adrenocortical Carcinoma Adrenal Cancer ACC Drug: ATR-101 Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of the Safety and Tolerability of ATR-101 in Adrenocortical Carcinoma

Resource links provided by NLM:

Further study details as provided by Millendo Therapeutics, Inc.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • Change in plasma cortisol levels [ Time Frame: Baseline and day 22 ]
  • 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

Estimated Enrollment: 78
Study Start Date: July 2013
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATR-101
ATR-101 will be administered as capsules or tablets by mouth once or twice per day to ascending dose cohorts
Drug: ATR-101


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01898715

Contact: Marian Ijzerman, PhD 734-845-9300
Contact: Marianne R Plaunt, PhD 734-249-6030

United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Tiffany Romershausen, MPH    813-745-2146    Tiffany.Romershausen@moffitt.org   
Principal Investigator: Jeffery Russell, MD, PhD         
United States, Maryland
National Institutes of Health/National Cancer Institute Recruiting
Bethesda, Maryland, United States, 20892
Contact: EOB Research Nurse    301-402-4395      
Principal Investigator: Electron Kebebew, MD         
United States, Michigan
University of Michigan Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48103
Contact: Cancer Answer Line    800-865-1125      
Principal Investigator: David C. Smith, MD         
United States, Texas
MDAnderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Trial Clinic    713-563-1930      
Principal Investigator: Aung Naing, MD         
Comprehensive Cancer Center Mainfranken, University Hospital of Würzburg Recruiting
Würzburg, Germany
Contact: Michaela Haaf    +49-931-201-39717      
Principal Investigator: Martin Fassnacht, MD         
Sponsors and Collaborators
Millendo Therapeutics, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Millendo Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01898715     History of Changes
Other Study ID Numbers: ATR-101-001
First Submitted: July 10, 2013
First Posted: July 12, 2013
Last Update Posted: February 7, 2017
Last Verified: February 2017

Keywords provided by Millendo Therapeutics, Inc.:
Adrenocortical carcinoma
Adrenal cancer

Additional relevant MeSH terms:
Adrenocortical Carcinoma
Adrenal Gland Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adrenal Cortex Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases
Adrenal Gland Diseases
Endocrine System Diseases