Trials / Completed
CompletedNCT00808418
A Study to Determine the Maximum Tolerated Dose of Elesclomol Sodium Given With a Fixed Dose of Docetaxel and Prednisone in Patients With Metastatic Prostate Cancer
A Phase 1 Study of Weekly Elesclomol Sodium Plus Docetaxel and Concomitant Prednisone in Subjects With Metastatic Castration Refractory Prostate Cancer (m-CRPC)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Synta Pharmaceuticals Corp. · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when combined with a fixed dose of docetaxel and concomitant prednisone. This study will also characterize the pharmacokinetics of elesclomol and docetaxel.
Detailed description
This aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose) when combined with a fixed dose of docetaxel and concomitant prednisone. This study will also characterize the pharmacokinetics of elesclomol and docetaxel.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Elesclomol Sodium | Chemotherapy agent |
| DRUG | Docetaxel | Chemotherapy agent |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2010-05-01
- Completion
- 2010-05-01
- First posted
- 2008-12-15
- Last updated
- 2014-02-03
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00808418. Inclusion in this directory is not an endorsement.