NCT01898715

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2013

Longer than P75 for phase_1

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

August 13, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2016

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2017

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

3.2 years

First QC Date

July 10, 2013

Last Update Submit

November 2, 2017

Conditions

Adrenocortical CarcinomaAdrenal CancerACC

Keywords

Adrenocortical carcinomaAdrenal cancerACC

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Area under the plasma concentration versus time curve (AUC) of ATR-101

    Day 1 and Day 22

  • Change in plasma cortisol levels

    Baseline and day 22

  • Change in objective measurement of tumor size

    Baseline and 8 weeks

Study Arms (1)

ATR-101

EXPERIMENTAL

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

Drug: ATR-101

Interventions

ATR-101DRUG
ATR-101

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

National Institutes of Health/National Cancer Institute

Bethesda, Maryland, 20892, United States

Location

University of Michigan Cancer Center

Ann Arbor, Michigan, 48103, United States

Location

MDAnderson Cancer Center

Houston, Texas, 77030, United States

Location

Comprehensive Cancer Center Mainfranken, University Hospital of Würzburg

Würzburg, Germany

Location

Related Publications (2)

  • Smith DC, Kroiss M, Kebebew E, Habra MA, Chugh R, Schneider BJ, Fassnacht M, Jafarinasabian P, Ijzerman MM, Lin VH, Mohideen P, Naing A. A phase 1 study of nevanimibe HCl, a novel adrenal-specific sterol O-acyltransferase 1 (SOAT1) inhibitor, in adrenocortical carcinoma. Invest New Drugs. 2020 Oct;38(5):1421-1429. doi: 10.1007/s10637-020-00899-1. Epub 2020 Jan 27.

    PMID: 31984451DERIVED

  • Lalli E, Sasano H. 5th International ACC Symposium: An Outlook to Current and Future Research on the Biology of Adrenocortical Carcinoma: Diagnostic and Therapeutic Applications. Horm Cancer. 2016 Feb;7(1):44-8. doi: 10.1007/s12672-015-0240-3. Epub 2015 Dec 14.

    PMID: 26666256DERIVED

MeSH Terms

Conditions

Adrenocortical CarcinomaAdrenal Gland Neoplasms

Interventions

N-(2,6-bis(1-methylethyl)phenyl)-N'-((1-(4-(dimethylamino)phenyl)cyclopentyl)methyl)urea hydrochloride

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsAdrenal Cortex NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteAdrenal Cortex DiseasesAdrenal Gland DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 12, 2013

Study Start

August 13, 2013

Primary Completion

November 2, 2016

Study Completion

October 17, 2017

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

US(4)DE(1)