Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Pharmaceutical Solutions

All Drugs and Chemicals

3.0 mg/kg bodyweight solution for infusion

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

Osteodex

Placebo

Camilla Thellenberg-Karlsson, MD, PhD.

Claes Nyman, MD, PhD.

Henriette Lindberg, MD, PhD.

Anders R Holmberg, CEO

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.

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.

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)

Life expectancy for participating subjects ≥ 6 months

EQ-5D-5L questionnaire, FACT-P questionnaire

DexTech Medical AB

Symptoms and General Pathology

Neoplasm Metastasis

formulation: solution for infusion route of administration: intravenous infusion

Anders Holmberg, MD

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).

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 diagnostic CT scan 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 (European Quality of Life - 5 Dimensions with 5 levels) 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 20 weeks from screening to the follow-up visit 2 weeks after the last dose. Each subject will receive 10 doses of investigational product. After the follow-up visit, the subject enters to long-term follow-up phase which lasts approximately 2 years.

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.

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

A 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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase IIb Study to Evaluate Efficacy and Tolerability of ODX (Osteodex) in Metastatic CRPC	NCT02378870	Prostate Cancer...	Osteodex Placebo	18 Years -	DexTech Medical AB
Study of ODX (Osteodex) in Metastatic Castration Resistant Prostate Cancer (CRPC)	NCT02825628	Prostate Cancer...	Osteodex	18 Years -	DexTech Medical AB
A Phase IIb Study to Evaluate Efficacy and Tolerability of ODX (Osteodex) in Metastatic CRPC	NCT02378870	Prostate Cancer...	Osteodex Placebo	18 Years -	DexTech Medical AB

Spots Global Cancer Trial Database for osteodex

Every month we try and update this database with for osteodex cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for osteodex

Every month we try and update this database with for osteodex cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for osteodex cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.