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

Conditions

ACC, Adrenal Cancer, Adrenocortical Carcinoma

Keywords

Adrenocortical carcinoma, Adrenal cancer, ACC

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.

Smith DC, Kroiss M, Kebebew E, Habra MA, Chugh R, Schneider BJ, Fassnacht M, Jafarinasabian P, Ijzerman MM, Lin VH, Mohideen P, Naing A.

2020-01-2741 citations

10.1007/s10637-020-00899-1

ATR-101 phase 1 clinical study for adrenocortical carcinoma.

Aung Naing, Siqing Fu, Mouhammed Amir Habra, Rashmi Chugh, Electron Kebebew et al. (15 authors)

Journal of Clinical Oncology2015-05-205 citations

10.1200/jco.2015.33.15_suppl.tps4585

Phase 1 study of ATR-101 in adrenocortical carcinoma (ACC): ATR-101-001.

Aung Naing, Mouhammed Amir Habra, Siqing Fu, Sarina A. Piha‐Paul, Marian Ijzerman et al. (8 authors)

Journal of Clinical Oncology2014-05-20

10.1200/jco.2014.32.15_suppl.tps4607

Interventions

DRUGATR-101

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 plasma cortisol levels	Baseline and day 22	—
Change in objective measurement of tumor size	Baseline and 8 weeks	CT or MRI scans will be read according to RECIST 1.1

Countries

Germany, United States

Outcome results

None listed