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

Phase 1

Completed

• Conditions: Adrenal Cancer; ACC; Adrenocortical Carcinoma
• Interventions: Drug: ATR-101

• Registration Number: NCT01898715
• Lead Sponsor: Millendo Therapeutics, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-07-10
• Study First Posted: 2013-07-12
• Study Start: 2013-08-13
• Primary Completion: 2016-11-02
• Study Completion: 2017-10-17
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ATR-101	ATR-101	ATR-101 will be administered as capsules or tablets by mouth once or twice per day to ascending dose cohorts

Primary Outcome Measures

Name	Time	Method
Frequency of dose-limiting toxicity and determination of maximum tolerated dose	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

Name	Time	Method
Change in plasma cortisol levels	Baseline and day 22
Area under the plasma concentration versus time curve (AUC) of ATR-101	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 objective measurement of tumor size	Baseline and 8 weeks	CT or MRI scans will be read according to RECIST 1.1

Trial Locations

Locations (5)

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, United States

Comprehensive Cancer Center Mainfranken, University Hospital of Würzburg; 🇩🇪 Würzburg, Germany