Phase 1 Study of the Safety and Tolerability of ATR-101 in Adrenocortical Carcinoma
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Millendo Therapeutics, Inc.
- Enrollment
- 63
- Locations
- 5
- Primary Endpoint
- Frequency of dose-limiting toxicity and determination of maximum tolerated dose
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Arms & Interventions
ATR-101
ATR-101 will be administered as capsules or tablets by mouth once or twice per day to ascending dose cohorts
Intervention: ATR-101 (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in plasma cortisol levels(Baseline and day 22)
- Area under the plasma concentration versus time curve (AUC) of ATR-101(Day 1 and Day 22)
- Change in objective measurement of tumor size(Baseline and 8 weeks)