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NCT01898715 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Study of ATR-101 in Subjects With Advanced Adrenocortical Carcinoma
A Phase 1 study of Adrenocortical Carcinoma and ACC, sponsored by Millendo Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
- 5
- Study locations
NCT01898715: Completed Phase 1 study of Adrenocortical Carcinoma and ACC, sponsored by Millendo Therapeutics.
NCT01898715 is a Phase 1 study of Adrenocortical Carcinoma and ACC that has completed, run by Millendo Therapeutics. The registered enrollment target is 63 participants, below the 356-participant average among 8 other Adrenocortical Carcinoma trials with a reported enrollment target (82% lower). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01898715, a Phase 1 study of Adrenocortical Carcinoma and ACC, has completed, sponsored by Millendo Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG ATR-101
Study Locations (5)
Florida
- Moffitt Cancer Center - Tampa
Maryland
- National Institutes of Health/National Cancer Institute - Bethesda
Michigan
- University of Michigan Cancer Center - Ann Arbor
Texas
- MDAnderson Cancer Center - Houston
Other
- Comprehensive Cancer Center Mainfranken, University Hospital of Würzburg - Würzburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2013-08-13 |
| Est. Completion | 2017-10-17 |
| Phase | Phase 1 |
What the finished NCT01898715 record still lists
NCT01898715 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 356-participant average among 8 other Adrenocortical Carcinoma trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Adrenocortical Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which ATR-101 is the first listed.
NCT01898715 lists 5 locations in 5 states (Florida, Maryland, Michigan).
Frequently Asked Questions
What is clinical trial NCT01898715 about?
NCT01898715 is a clinical study titled "Phase 1 Study of ATR-101 in Subjects With Advanced 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...
What is the current status of trial NCT01898715?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2013-08-13. Estimated completion is 2017-10-17.
What conditions does trial NCT01898715 study?
This clinical trial studies the following conditions: Adrenocortical Carcinoma, ACC, Adrenal Cancer.
What interventions are being tested in trial NCT01898715?
The interventions under investigation include: ATR-101 (DRUG).
Who is sponsoring clinical trial NCT01898715?
This trial is sponsored by Millendo Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01898715 being conducted?
This trial has 5 study locations across Florida, Maryland, Michigan, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01898715's enrollment target sits among peer trials
63 6th of 8 higher than 3 of 8 other Adrenocortical Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Adrenocortical Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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