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

November 2, 2017 updated by: Millendo Therapeutics, Inc.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Würzburg, Germany
        • Comprehensive Cancer Center Mainfranken, University Hospital of Würzburg
  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health/National Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • University of Michigan Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • MDAnderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Occurrence of DLT at 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 and Day 22
Change in plasma cortisol levels
Time Frame: Baseline and day 22
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
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Millendo Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2013

Primary Completion (Actual)

November 2, 2016

Study Completion (Actual)

October 17, 2017

Study Registration Dates

First Submitted

July 10, 2013

First Submitted That Met QC Criteria

July 10, 2013

First Posted (Estimate)

July 12, 2013

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 2, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATR-101-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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