Clinical trial · Interventional
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)
NCT00808418CI-TRIAL-00013639completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Docetaxel | Drug | Docetaxel | ALIAS |
| Elesclomol Sodium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cohort
- interventionNames
- Drug: Elesclomol Sodium
- Drug: Docetaxel
Primary outcomes (3)
- measure
- To characterize the safety and tolerability of escalating doses of elesclomol sodium in combination with a fixed dose of docetaxel and concomitant prednisone administered weekly to m-CRPC subjects
- timeFrame
- Jan 2011
- measure
- To determine the MTD of elesclomol sodium when administered with 30 mg/m2 weekly docetaxel
- timeFrame
- Jan 2011
- measure
- To characterize the pharmacokinetics of elesclomol sodium and docetaxel in this population
- timeFrame
- Jan 2011
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Confirmed metastatic prostate cancer * No more than one prior chemotherapy on which the disease progressed * ECOG performance status of less than or equal to 2 * Adequate bone marrow, renal and hepatic functions as defined in the protocol * Neuropathy less than or equal to 2 * Reliable venous access for frequent study drug infusions Exclusion Criteria * Significant cardiovascular disease * Known active brain metastases * Subjects that have received treatment for other malignancies with in the past 5 years * Other clinically significant uncontrolled conditions
References
Publications (0)
Data not yet available
No reference posted for this study.