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

Adrenocortical Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01898715
• Other study ID #: ATR-101-001
• 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
• 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.

Related Conditions & MeSH terms

• ACC
• Adrenal Cancer
• Adrenal Gland Neoplasms
• Adrenocortical Carcinoma
• Carcinoma

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