A Phase IIb Study to Evaluate Efficacy and Tolerability of ODX (Osteodex) in Metastatic CRPC
Status:
Terminated
Trial end date:
2015-09-01
Target enrollment:
Participant gender:
Summary
This phase IIb study is a randomized, double-blind, placebo-controlled multi-center study
evaluating efficacy and tolerability 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 evaluate the relative change of response markers to bone
metabolism (B-ALP and S-P1NP) The following objectives will also be evaluated: overall
survival, PSA response, other response markers related to bone metabolism (S-CTX and
osteocalcin), safety, tolerability, pain and quality of life.