Dose Escalation Study of Radium-223 Dichloride in Patients With Advanced Skeletal Metastases

PHASE1CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

August 14, 2001

Primary Completion Date

June 25, 2003

Study Completion Date

June 25, 2003

Conditions
Neoplasm Metastasis
Interventions
RADIATION

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

Trial Locations (3)

Unknown

The Norwegian Radium Hospital, Oslo

University Hospital of North Norway, Tromsø

Karolinska University Hospital, Stockholm

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT01798108 - Dose Escalation Study of Radium-223 Dichloride in Patients With Advanced Skeletal Metastases | Biotech Hunter | Biotech Hunter