This phase Ib combination study is being conducted to assess the safety and tolerability of radium Ra 223 dichloride in combination with paclitaxel in cancer subjects with bone lesions with special focus on Grade 3/4 incidence of neutro- and/or thrombocytopenia and exploration of the mode of interaction (i.e. additive or synergistic interaction) between the selected chemotherapy and radium Ra 223 dichloride with regard to myelosuppression.
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
15
50 kBq/kg intravenous injection once every 4 weeks, will be administrated from cycle 2 up to 6 cycles
90 mg/m2 intravenous injection per week in a 3-week-on / 1-week-off regimen, will be administered as per local standard of care, starting in cycle 1
Unnamed facility
HUS, Finland
Unnamed facility
Haifa, Israel
Unnamed facility
Tel Aviv, Israel
Unnamed facility
Sutton, Surrey, United Kingdom
Unnamed facility
Sheffield, United Kingdom
The percentage of participants with thrombocytopenia during cycle 1 (paclitaxel alone), 2 and 3 (combination treatment)
Time frame: Approximately 12 weeks
The percentage of participants with neutropenia during cycle 1 (paclitaxel alone), 2 and 3 (combination treatment)
Time frame: Approximately 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.