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The purpose of this study is to determine the maximum tolerated dose (MTD) of X-82 as a single agent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| X-82 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| X-82 | Drug | Dose escalation starting at 20 mg, oral once or twice a day, 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose | To determine the maximum tolerated dose (MTD) of X-82 as a single agent. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary Pharmacokinetics of X-82 given as a single agent | To characterize the preliminary pharmacokinetics (PK) of X-82 given as a single agent. | 12 months |
| Preliminary biological activity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gina Courtney, MD | Study PI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30478190 | Derived | Bendell JC, Patel MR, Moore KN, Chua CC, Arkenau HT, Dukart G, Harrow K, Liang C. Phase I, First-in-Human, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Vorolanib in Patients with Advanced Solid Tumors. Oncologist. 2019 Apr;24(4):455-e121. doi: 10.1634/theoncologist.2018-0740. Epub 2018 Nov 26. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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To explore the preliminary biological activity and clinical tumor response after treatment with X-82 given as a single agent.
| 18 months |