17110 - radium Ra 223 dichloride plus paclitaxel in cancer patients
Research type
Research Study
Full title
An open-label, multi-center, non-randomized Phase Ib study to investigate safety and tolerability of radium Ra 223 dichloride (BAY 88-8223) administered in combination with paclitaxel in cancer subjects with bone lesions
IRAS ID
181901
Contact name
Juanita Lopez
Contact email
Sponsor organisation
Bayer HealthCare AG
Eudract number
2015-000083-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 4 months, 31 days
Research summary
This clinical research study is to test a drug combination for patients with cancer who have at least two bone lesions. The main goal of this study is to understand the influence of the study drug, radium Ra 223 dichloride, combined with paclitaxel treatment on the rate of neutropenia (the lowering of the number of white blood cells) and thrombocytopenia (reduction in the number of platelets which are blood cells for blood clotting).
Radium Ra 223 dichloride is a radioactive drug that is taken up by bones after it is injected into the body. It works by giving off radioactivity, which kills the tumour cells that have spread to the bone. Radium Ra 223 dichloride releases a type of radioactivity that travels a very short distance. As a result, most of the effects of the drug are limited to the bones. Radium Ra 223 dichloride was approved in 2013 by the US Food and Drug Administration (FDA) and health authorities in Europe, but is not approved yet to be combined with chemotherapeutic agents, such as paclitaxel.
This study will be conducted at about 5 clinical sites in 3 countries, and approximately 20 patients will be enrolled in the study. All of the participants will be at least 18 years of age or older.
Participation in this study will involve approximately 23 study visits, over a period of approximately 8-9 months. Study procedures to be performed include physical examinations, blood samples, ECGs (electrocardiograms), bone scans and CT or MRI scans.
The sponsor of this study is Bayer HealthCare AG, a pharmaceutical company with head office in D-51368 Leverkusen, Germany.REC name
London - Surrey Borders Research Ethics Committee
REC reference
15/LO/1117
Date of REC Opinion
8 Sep 2015
REC opinion
Further Information Favourable Opinion