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A Phase IIb Study to Evaluate Efficacy and Tolerability of ODX (Osteodex) in Metastatic CRPC

NCT02378870 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2016-06-30

No results posted yet for this study

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.

Conditions

  • Prostate Cancer Metastatic

Interventions

DRUG

Osteodex

Osteodex 3.0 mg/kg given every two week, maximum 13 times.

DRUG

Placebo

Sponsors & Collaborators

  • DexTech Medical AB

    lead INDUSTRY

Principal Investigators

  • Camilla Thellenberg-Karlsson, MD, PhD. · Oncology Department, Norrland University Hospital (NUS) Umeå Sweden

  • Claes Nyman, MD, PhD. · Urology Clinic, Stockholm South General Hospital (SÖS) Stockholm Sweden

  • Henriette Lindberg, MD, PhD. · Oncology Department, Herlev Hospital, Copenhagen Denmark

  • Anders R Holmberg, CEO · DexTech Medical AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-06-30
Completion
2015-09-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02378870 on ClinicalTrials.gov