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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Millendo Therapeutics, Inc.
Information provided by (Responsible Party):
Millendo Therapeutics, Inc. Identifier:
First received: July 10, 2013
Last updated: May 11, 2016
Last verified: May 2016
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
Drug: ATR-101
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in objective measurement of tumor size [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    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 2017
Estimated Primary Completion Date: February 2017 (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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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   
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 Identifier (NCT Number):
Responsible Party: Millendo Therapeutics, Inc. Identifier: NCT01898715     History of Changes
Other Study ID Numbers: ATR-101-001 
Study First Received: July 10, 2013
Last Updated: May 11, 2016
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Adrenal Gland Diseases
Adrenocortical Carcinoma
Adrenal Cortex Diseases
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial processed this record on May 26, 2016