drugset / Trial / NCT01595087
A Phase I/II Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)
NaSingle-groupOpen-labelTreatment
Summary
This phase I/IIa study is a multi-center, prospective, open-label study evaluating safety and biological efficacy of up to six dose levels of Osteodex of patients with metastatic castration resistant prostate cancer (CRPC). Osteodex is a poly-bisphosphonate containing three known substances; dextran, alendronate and guanidine. The objective of the study is to define the maximum tolerable dose of Osteodex when given every third week. The following objectives will also be evaluated: overall survival, PSA response, response markers related to bone metabolism (S-ALP and U-NTx), Quality of Life and assessment of pharmacokinetic parameters.
Timeline
- Start
- 2012-01
- Primary completion
- 2013-06
- Completion
- 2013-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Osteodex | Other / unclassified | 0.1 mg/kg | Other |
| Subject | Osteodex | Other / unclassified | 0.3 mg/kg | Other |
| Subject | Osteodex | Other / unclassified | 0.6 mg/kg | Other |
| Subject | Osteodex | Other / unclassified | 0.9 mg/kg | Other |
| Subject | Osteodex | Other / unclassified | 1.2 mg/kg | Other |
| Subject | Osteodex | Other / unclassified | 1.5 mg/kg | Other |
| Subject | Osteodex | Other / unclassified | 3 mg/kg | Other |