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

Millendo Therapeutics

Status and phase

Completed

Phase 1

Conditions

Adrenocortical Carcinoma

ACC

Adrenal Cancer

Treatments

Drug: ATR-101

Study type

Interventional

Funder types

Industry

Identifiers

NCT01898715

ATR-101-001

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.