31
Participants
Start Date
August 14, 2001
Primary Completion Date
June 25, 2003
Study Completion Date
June 25, 2003
Radium-223 dichloride (BAY88-8223)
\- Single injection. Starting dose 46 kBq/kg b.w. Escalating doses 93, 163, 213 and 250 kBq/kg b.w. (9.8.2 Changes in addition to those described in amendments) After completion of the five dose levels above, the protocol was amended and the study extended to include patients to received multiple injections of Radium-223 - Re-treatment: Patients who had earlier been included in the study and received dose levels 46, 93 or 163 kBq/kg b.w. could be given a second injection, provided that the total dose did not exceed 250 kBq/kg b.w. - Fractionated dose (multiple dosing) Patients were given multiple injections in treatment: 5 injections of 50 kBq/kg b.w. at 3 weeks intervals. Patients were given multiple injections in treatment: 2 injections of 125 kBq/kg b.w. at 6 weeks interval
The Norwegian Radium Hospital, Oslo
University Hospital of North Norway, Tromsø
Karolinska University Hospital, Stockholm
Lead Sponsor
Bayer
INDUSTRY