NCT01898715

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

Completed Phase 1 Last updated 6 November 2017

What this trial tests

Phase 1 trial testing ATR-101 in Adrenocortical Carcinoma in 63 participants. Completed in 17 October 2017.

Timeline

13 August 2013

Primary endpoint
2 November 2016

17 October 2017

Quick facts

Lead sponsor	Millendo Therapeutics, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	63
Start date	13 August 2013
Primary completion	2 November 2016
Estimated completion	17 October 2017
Sites	5 locations across United States, Germany

Drugs / interventions tested

• ATR-101 — full drug profile →

Conditions studied

• Adrenocortical Carcinoma — all drugs for Adrenocortical Carcinoma →
• Adrenal Cancer — all drugs for Adrenal Cancer →
• ACC — all drugs for ACC →

Sponsor

Millendo Therapeutics, Inc.

Who can join

18 and older, any sex, with Adrenocortical Carcinoma or Adrenal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Lipid metabolism in pancreatic cancer: emerging roles and potential targets.
   Yin X, Xu R, Song J, Ruze R, et al · · 2022 · cited 91× · PMID 36107801 · DOI 10.1002/cac2.12360
2. The Lipid Metabolic Landscape of Cancers and New Therapeutic Perspectives.
   Wang W, Bai L, Li W, Cui J. · · 2020 · cited 86× · PMID 33364199 · DOI 10.3389/fonc.2020.605154
3. Lipid Metabolism in Glioblastoma: From De Novo Synthesis to Storage.
   Kou Y, Geng F, Guo D. · · 2022 · cited 59× · PMID 36009491 · DOI 10.3390/biomedicines10081943
4. Active steroid hormone synthesis renders adrenocortical cells highly susceptible to type II ferroptosis induction.
   Weigand I, Schreiner J, Röhrig F, Sun N, et al · · 2020 · cited 51× · PMID 32184394 · DOI 10.1038/s41419-020-2385-4
5. A phase 1 study of nevanimibe HCl, a novel adrenal-specific sterol O-acyltransferase 1 (SOAT1) inhibitor, in adrenocortical carcinoma.
   Smith DC, Kroiss M, Kebebew E, Habra MA, et al · · 2020 · cited 41× · PMID 31984451 · DOI 10.1007/s10637-020-00899-1
6. Sterol O-Acyl Transferase 1 as a Prognostic Marker of Adrenocortical Carcinoma.
   Lacombe AMF, Soares IC, Mariani BMP, Nishi MY, et al · · 2020 · cited 22× · PMID 31963898 · DOI 10.3390/cancers12010247
7. A Phase 2, Multicenter Study of Nevanimibe for the Treatment of Congenital Adrenal Hyperplasia.
   El-Maouche D, Merke DP, Vogiatzi MG, Chang AY, et al · · 2020 · cited 16× · PMID 32589738 · DOI 10.1210/clinem/dgaa381
8. The challenge of developmental therapeutics for adrenocortical carcinoma.
   Costa R, Carneiro BA, Tavora F, Pai SG, et al · · 2016 · cited 16× · PMID 27102148 · DOI 10.18632/oncotarget.8774