Trials / Completed
CompletedNCT01228760
A Study to Determine the Maximum Tolerated Dose of ASG-5ME in Subjects With Castration-Resistant Prostate Cancer
A Phase 1, Open-label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of ASG-5ME Monotherapy in Subjects With Castration-Resistant Prostate Cancer (CRPC)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 46 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this dose escalation study is to determine the Maximum Tolerated Dose (MTD) and the recommended Phase 2 dose of ASG-5ME in subjects with castration-resistant prostate cancer (CRPC).
Detailed description
The study has two components. The first aims to establish a safe dose of ASG-5ME. Once identified, the safety and preliminary estimate of antitumor activity of ASG-5ME will be tested in additional subjects with castration-resistant prostate cancer (CRPC) who are either chemotherapy naïve or chemotherapy exposed in expanded cohorts.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ASG-5ME | IV |
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2013-02-01
- Completion
- 2013-02-01
- First posted
- 2010-10-26
- Last updated
- 2013-06-07
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01228760. Inclusion in this directory is not an endorsement.