Dose Escalation Study of Radium-223 Dichloride in Patients With Advanced Skeletal Metastases
|ClinicalTrials.gov Identifier: NCT01798108|
Recruitment Status : Completed
First Posted : February 25, 2013
Last Update Posted : May 19, 2017
A new bone-seeking radiopharmaceutical drug, called Radium-223 dichloride (formerly known as "Alpharadin"), is currently under development. It is an injectable aqueous solution containing radium-223, a radionuclide that emits radiation of another quality and with a different distribution than radiopharmaceuticals currently in use.
After injection of the drug into the blood, a large portion of the drug will accumulate in the bones, and irradiate the skeletal metastases. The drug is expected to be retained longer in the painful sites of bone than in other sites of the body, and may alleviate pain through its radiation. Radium-223 is expected to be both efficacious as regards the targeted localised irradiation, and also to have a favourable safety profile.
The radiopharmaceutical drug Radium-223 has not been given to humans before. In this first clinical study in man, a so-called phase I study, the safety, tolerance and the toxicity of various radioactivity doses of Radium-223 will be evaluated.
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm Metastasis||Radiation: Radium-223 dichloride (BAY88-8223)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Open-label, Multicenter, Dose-escalating Study of Radium-223 in Patients With Advanced Skeletal Metastases|
|Actual Study Start Date :||August 14, 2001|
|Actual Primary Completion Date :||June 25, 2003|
|Actual Study Completion Date :||June 25, 2003|
Experimental: Radium-223 dichloride
The study had 2 parts. Part 1a was designed with single injections of Radium-223 given to cohorts of 5 patients for each of 5 pre-defined dose levels. Part 1b was designed to retreat and fractionate the dose of Radium-223 in multiple injections.Based on the revised correction factor by calibration, recalculations verified that the single injection doses administered in the part 1a were : 46, 93, 163, 213 and 250 kBq/kg b.w. Two re-treated patients (dose group 6) received a second dose that resulted in a total dose of 250 kBq/kg b.w. The fractionated doses were 1/5 and ½ of the highest dose in part1b (i.e. 250kBq so 5 x 50 and 2 x 125 kBq/kg b.w. respectively).
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
- Number of participants with predetermined adverse events (dose limiting toxicity [DLT]) as a measure of safety and tolerability while dose escalating [ Time Frame: Up to 8 weeks from injection ]
- Blood clearance of radioactivity [ Time Frame: 48 hours after the last injection ]
- Quality of Life Questionnaire [ Time Frame: 8 weeks after the last injection ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798108
|The Norwegian Radium Hospital|
|University Hospital of North Norway|
|Karolinska University Hospital|
|Study Director:||Bayer Study Director||Bayer|