Back to resultsPhase 1 Study of ATR-101 in Subjects With Advanced Adrenocortical Carcinoma
Primary Purpose
Adrenocortical Carcinoma, Adrenal Cancer, ACC
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ATR-101
Sponsored by
About this trial
This is an interventional treatment trial for Adrenocortical Carcinoma focused on measuring Adrenocortical carcinoma, Adrenal cancer, ACC
Eligibility Criteria
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.
Sites / Locations
- Moffitt Cancer Center
- National Institutes of Health/National Cancer Institute
- University of Michigan Cancer Center
- MDAnderson Cancer Center
- Comprehensive Cancer Center Mainfranken, University Hospital of Würzburg
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ATR-101
Arm Description
ATR-101 will be administered as capsules or tablets by mouth once or twice per day to ascending dose cohorts
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Change in plasma cortisol levels
Change in objective measurement of tumor size
CT or MRI scans will be read according to RECIST 1.1
Full Information
NCT ID
NCT01898715
First Posted
July 10, 2013
Last Updated
November 2, 2017
Sponsor
Millendo Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01898715
Brief Title
Phase 1 Study of ATR-101 in Subjects With Advanced Adrenocortical Carcinoma
Official Title
Phase 1 Study of the Safety and Tolerability of ATR-101 in Adrenocortical Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
August 13, 2013 (Actual)
Primary Completion Date
November 2, 2016 (Actual)
Study Completion Date
October 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Millendo Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenocortical Carcinoma, Adrenal Cancer, ACC
Keywords
Adrenocortical carcinoma, Adrenal cancer, ACC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ATR-101
Arm Type
Experimental
Arm Description
ATR-101 will be administered as capsules or tablets by mouth once or twice per day to ascending dose cohorts
Intervention Type
Drug
Intervention Name(s)
ATR-101
Primary Outcome Measure Information:
Title
Frequency of dose-limiting toxicity and determination of maximum tolerated dose
Description
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 Outcome Measure Information:
Title
Area under the plasma concentration versus time curve (AUC) of ATR-101
Description
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
Title
Change in plasma cortisol levels
Time Frame
Baseline and day 22
Title
Change in objective measurement of tumor size
Description
CT or MRI scans will be read according to RECIST 1.1
Time Frame
Baseline and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
National Institutes of Health/National Cancer Institute
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Facility Name
University of Michigan Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
MDAnderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Comprehensive Cancer Center Mainfranken, University Hospital of Würzburg
City
Würzburg
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
31984451
Citation
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.
Results Reference
derived
PubMed Identifier
26666256
Citation
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.
Results Reference
derived
Learn more about this trial
Phase 1 Study of ATR-101 in Subjects With Advanced Adrenocortical Carcinoma
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