drugset / Trial / NCT02349139
Safety, Preliminary Efficacy and Pharmacokinetics of ASN001 in Metastatic Castrate Resistant Prostate Cancer
SequentialOpen-labelTreatment
Summary
This study will be conducted in three parts. Part A is a dose-escalation study to determine two safe and tolerable doses of ASN001 for men with metastatic castration resistant prostate cancer. Part A will also characterize the pharmacokinetics and pharmacodynamics of the ASN001 through blood sampling. Subjects in Part B will receive one of two doses identified in Part A to determine which one is more effective, and collect additional pharmacokinetic data. Part C is an extension for subjects completing either Part A or B.
Timeline
- Start
- 2015-01-19
- Primary completion
- 2017-07-14
- Completion
- 2017-08-17
Outcome
Outcome not reported
Stopped (Business): “Business Decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ASN001 | Unknown | 50 mg | — |
| Subject | ASN001 | Unknown | 100 mg | — |
| Subject | ASN001 | Unknown | 200 mg | — |
| Subject | ASN001 | Unknown | 300 mg | — |
| Subject | ASN001 | Unknown | 400 mg | — |