NCT02378870

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

A Randomised, Double-blind, Placebo-controlled Multicentre Phase II Study to Evaluate Efficacy and Tolerability of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: DexTech Medical AB · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Males, diagnosed with CRPC, who fulfil the inclusion criteria and does not have any exclusion criteria, will be asked to participate in the study. The subject will be informed orally and in writing about the study procedures and give written informed consent, prior to study start. At the screening visit the following examinations are performed: Physical examination, medical history and concomitant medication. Heart rate, blood pressure, weight, height, body temperature and respiratory rate are measured. Blood samples are drawn and urine sample is collected. ECG is recorded. Bone scan and PET-CT are also performed. At the next visit, baseline, the subject is examined physically and heart rate, blood pressure, weight, body temperature and respiratory rate are measured, ECG is recorded, blood samples drawn and urine sample collected. FACT-P and EQ-5D-5L questionnaire are filled out by the subject. Adverse events and concomitant medication is documented and the first dose of the investigational product is given. The subject is surveyed for 3 hours at the hospital. The duration of the study for the individual subject will be approximately 30 weeks from screening to the follow-up visit 2 weeks after the last dose. Each subject will receive at least 7 doses and maximum 13 doses of investigational product. A Data Monitoring Committee (DMC) will be designated and will be responsible to monitor/review all study related safety data. After review of safety data the DMC will provide recommendation as to whether the dose escalation can proceed as planned according to the protocol.

Conditions

• Prostate Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Osteodex	Osteodex 3.0 mg/kg given every two week, maximum 13 times.
DRUG	Placebo

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-06-01
• Completion: 2015-09-01
• First posted: 2015-03-04
• Last updated: 2016-06-30

Locations

1 site across 1 country: Sweden