Status:
COMPLETED
Phase 1 Study of ATR-101 in Subjects With Advanced Adrenocortical Carcinoma
Lead Sponsor:
Millendo Therapeutics, Inc.
Conditions:
Adrenocortical Carcinoma
Adrenal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 13 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2017
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01898715
Start Date
August 13 2013
End Date
October 17 2017
Last Update
November 6 2017
Active Locations (5)
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1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
2
National Institutes of Health/National Cancer Institute
Bethesda, Maryland, United States, 20892
3
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48103
4
MDAnderson Cancer Center
Houston, Texas, United States, 77030