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

Millendo Therapeutics, Inc.63 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Adrenocortical Carcinoma Adrenal Cancer ACC

Interventions

ATR-101DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

Moffitt Cancer Center

Tampa, Florida, United States

National Institutes of Health/National Cancer Institute

Bethesda, Maryland, United States

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

MDAnderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: Occurrence of DLT at 28 days

Secondary Outcomes

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.

Time frame: Day 1 and Day 22

Change in plasma cortisol levels

Time frame: Baseline and day 22

Change in objective measurement of tumor size

CT or MRI scans will be read according to RECIST 1.1

Time frame: Baseline and 8 weeks

Data from ClinicalTrials.gov

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