Adrenocortical CarcinomaPhase 1NCT01898715
Phase 1 Study of ATR-101 in Subjects With Advanced Adrenocortical Carcinoma
A Phase 1 study testing ATR-101 in people with Adrenocortical Carcinoma and Adrenal Cancer, run by Millendo Therapeutics, Inc. at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenocortical Carcinoma, Adrenal Cancer, ACC
- What is being tested?
- ATR-101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 13 Aug 2013to 17 Oct 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
University of Michigan Cancer Center
Ann Arbor, Michigan, 48103
National Institutes of Health/National Cancer Institute
Bethesda, Maryland, 20892
MDAnderson Cancer Center
Houston, Texas, 77030
Moffitt Cancer Center
Tampa, Florida, 33612
Germany1 site
Comprehensive Cancer Center Mainfranken, University Hospital of Würzburg
Würzburg
About this study
Official title: Phase 1 Study of the Safety and Tolerability of ATR-101 in Adrenocortical Carcinoma
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.
- Conditions
- Adrenocortical Carcinoma, Adrenal Cancer, ACC
- Being tested
- ATR-101
- Keywords
- Adrenocortical carcinoma, Adrenal cancer, ACC
- Medical subject headings
- Adrenocortical Carcinoma, Adrenal Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATR-101Drug
| Study group | Role | What they receive |
|---|---|---|
| ATR-101 | Experimental | ATR-101 will be administered as capsules or tablets by mouth once or twice per day to ascending dose cohorts Receives: Drug: ATR-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Occurrence of DLT at 28 days
Secondary outcomes (3)
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.
Measured: Day 1 and Day 22
Change in plasma cortisol levels
Measured: Baseline and day 22
Change in objective measurement of tumor size
CT or MRI scans will be read according to RECIST 1.1
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study start13 Aug 2013
- Primary completion2 Nov 2016
- Study completion17 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adrenocortical CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millendo Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898715
- Sponsor's protocol ID
- ATR-101-001
- Status last verified
- Nov 2017
- First submitted
- 10 Jul 2013
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31984451Lalli 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.
PubMed 26666256
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the Safety and Tolerability of ATR-101 in Adrenocortical Carcinoma
- ClinicalTrials.gov ID
- NCT01898715
- Acronym / sponsor ID
- ATR-101-001
- Conditions
- Adrenocortical Carcinoma, Adrenal Cancer, ACC
- Keywords
- Adrenocortical carcinoma, Adrenal cancer, ACC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Millendo Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2013 (actual)
- Primary completion
- 2 Nov 2016 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 12 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATR-101 | Experimental | Drug: ATR-101ATR-101 will be administered as capsules or tablets by mouth once or twice per day to ascending dose cohorts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATR-101 | Drug | ATR-101 |
Primary outcome
Frequency of dose-limiting toxicity and determination of maximum tolerated dose
Time frame: 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.
3 secondary outcomes
Area under the plasma concentration versus time curve (AUC) of ATR-101
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
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 31984451Smith 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.
- Derived from this study: PubMed 26666256Lalli 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.
Related trials for Adrenocortical Carcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruitingPhase 2
Pembrolizumab in the Treatment of Advanced, Progressive Adrenocortical Carcinoma.
Adrenocortical Carcinoma
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
RecruitingPhase 2
Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer
Locally Advanced Adrenal Cortical Carcinoma, Metastatic Adrenal Cortical Carcinoma
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATR-101 in people with Adrenocortical Carcinoma and Adrenal Cancer, run by Millendo Therapeutics, Inc. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of dose-limiting toxicity and determination of maximum tolerated dose (time frame: Occurrence of DLT at 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01898715, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.