Eligible subjects must have completed 6 doses of treatment of radium-223 dichloride and experienced no radium-223 dichloride-related SAEs (serious adverse events) or CTCAE (Common Terminology Criteria for Adverse Events) Grade 3 or 4 adverse event during or after the initial course of radium-223 dichloride that led to the discontinuation of treatment. 40 Subjects will be enrolled and will receive up to 6 doses of radium-223 dichloride 50 kBq/kg IV every 4 weeks. The subject will be evaluated for AEs (adverse events) and laboratory tests at each visit every 4 weeks, prior to receiving radium-223 dichloride. After the end of treatment visit the subjects will enter the active follow up period. Related AEs and SAEs and Lab tests will be evaluated at each visit every 4 weeks for the first 12 weeks, then every 12 weeks for up to 2 years after the last dose of radium-223 dichloride. After the 2 years of active follow-up, subjects will enter the long-term follow-up period and will be followed via telephone follow-up at 6-month intervals for late toxicities and survival up to 7 years after the last dose of radium-223 dichloride or until death. Joint safety reviews will regularly take place to oversee safety of the subjects conducted at regular intervals. An interim analysis of the safety data will be conducted during the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
Unnamed facility
New Orleans, Louisiana, United States
Unnamed facility
Omaha, Nebraska, United States
Unnamed facility
Syracuse, New York, United States
Unnamed facility
Kuopio, Finland
Unnamed facility
Haifa, Israel
Unnamed facility
Jerusalem, Israel
Unnamed facility
Kfar Saba, Israel
Unnamed facility
Petah Tikva, Israel
Unnamed facility
Forlì-Cesena, Emilia-Romagna, Italy
Unnamed facility
Milan, Lombardy, Italy
...and 6 more locations
Number of Participants With Treatment-emergent Adverse Events (AEs)
An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom, or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. A treatment-emergent adverse events (TEAE) is defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of radium-223 dichloride.
Time frame: Up to 2.5 years
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
TESAE occurred after the start of radium-223 dichloride treatment until 30 days after the last dose and results in death; is life-threatening; requires inpatient hospitalization or prolongs existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly / birth defect; is another medically important serious event as judged by the investigator; or is an occurrence of leukemia, myelodysplastic syndrome, aplastic anemia, myelofibrosis, and primary bone cancer or any other new primary malignancy, such as acute myeloid leukemia.
Time frame: Up to 2.5 years
Number of Participants With Radium-223 Dichloride-related AEs in the Active Follow-up Period
An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom, or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study.
Time frame: Up to 2 years after last treatment
Number of Participants With Radium-223 Dichloride-related SAEs in the Active Follow-up Period
Treatment-related SAE is any SAE that, according to the investigator's causality assessment, is possibly or probably related to treatment with radium-223 dichloride.
Time frame: Up to 2 years after last treatment
Number of Participants With High/Low Abnormalities in Hematology Variables at Any Visit After Treatment Start
Time frame: Up to 2.5 years
Number of Participants With High/Low Abnormalities in Biochemistry Variables at Any Visit After Treatment Start
Time frame: Up to 2.5 years
Number of Participants Who Discontinued Radium-223 Dichloride Treatment Due to Treatment Emergent AEs or Death
An adverse event (AE) is any untoward medical occurrence (i.e., any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom, or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study. A treatment-emergent adverse events (TEAE) is defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of radium-223 dichloride.
Time frame: Up to 2.5 years
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