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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01898715
Other study ID # ATR-101-001
Secondary ID
Status Completed
Phase Phase 1
First received July 10, 2013
Last updated November 2, 2017
Start date August 13, 2013
Est. completion date October 17, 2017

Study information

Verified date November 2017
Source Millendo Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date October 17, 2017
Est. primary completion date November 2, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
ATR-101


Locations

Country Name City State
Germany Comprehensive Cancer Center Mainfranken, University Hospital of Würzburg Würzburg
United States University of Michigan Cancer Center Ann Arbor Michigan
United States National Institutes of Health/National Cancer Institute Bethesda Maryland
United States MDAnderson Cancer Center Houston Texas
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Millendo Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of dose-limiting toxicity and determination of maximum tolerated dose 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 Area under the plasma concentration versus time curve (AUC) of ATR-101 Plasma levels of ATR-101 will be assessed after daily oral dosing and pharmacokinetic parameters will be calculated. Day 1 and Day 22
Secondary Change in plasma cortisol levels Baseline and day 22
Secondary Change in objective measurement of tumor size CT or MRI scans will be read according to RECIST 1.1 Baseline and 8 weeks
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