Adrenocortical Carcinoma Clinical Trial
Official title:
Phase 1 Study of the Safety and Tolerability of ATR-101 in Adrenocortical Carcinoma
Verified date | November 2017 |
Source | Millendo Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 63 |
Est. completion date | October 17, 2017 |
Est. primary completion date | November 2, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Germany | Comprehensive Cancer Center Mainfranken, University Hospital of Würzburg | Würzburg | |
United States | University of Michigan Cancer Center | Ann Arbor | Michigan |
United States | National Institutes of Health/National Cancer Institute | Bethesda | Maryland |
United States | MDAnderson Cancer Center | Houston | Texas |
United States | Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Millendo Therapeutics, Inc. |
United States, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Occurrence of DLT at 28 days | |
Secondary | 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. | Day 1 and Day 22 | |
Secondary | Change in plasma cortisol levels | Baseline and day 22 | ||
Secondary | Change in objective measurement of tumor size | CT or MRI scans will be read according to RECIST 1.1 | Baseline and 8 weeks |
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