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Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)

NCT02825628 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2024-08-29

No results posted yet for this study

Summary

This is a phase II randomised, double-blind, dose finding, repeat dose Phase II multicentre study of ODX for the treatment of patients with castration resistant prostate cancer (CRPC) and skeletal metastases.

The primary objective is to evaluate the relative change from baseline in response markers related to bone metabolism (alkaline phosphatase (B-ALP) and S P1NP) at 12 weeks of three different doses of ODX (3.0, 6.0 and 9.0 mg/kg ODX).

Conditions

  • Prostate Cancer Metastatic

Interventions

DRUG

Osteodex

formulation: solution for infusion route of administration: intravenous infusion

Sponsors & Collaborators

  • DexTech Medical AB

    lead INDUSTRY

Principal Investigators

  • Anders Holmberg, MD · 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
2016-05-31
Primary Completion
2018-06-30
Completion
2020-06-30

Countries

  • Estonia
  • Finland
  • Latvia
  • Sweden

Study Locations

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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 NCT02825628 on ClinicalTrials.gov