Which Phase 1–2 clinical studies tested Xofigo (radium-223 dichloride)?
Xofigo (radium Ra 223 dichloride) was studied in early clinical trials that evaluated its safety, tolerability, dose, and initial anti-tumor activity in people with advanced prostate cancer, including patients with bone-predominant disease. The development program includes Phase 1 and Phase 2 studies (often conducted as dose-escalation and then expansion cohorts) to establish an initial dosing approach before larger Phase 3 trials.
What were the key goals in Phase 1 and Phase 2?
Across Phase 1–2 studies, researchers typically focused on:
- Safety and tolerability of the radiopharmaceutical at escalating dose levels
- Characterization of treatment-related adverse events
- Evidence of biologic activity in bone lesions (including the expectation that the drug targets bone metastases)
- Early signals of anti-cancer activity, such as changes in markers used in prostate cancer trials and imaging-based assessments
How were patients selected in early studies?
Early Xofigo trials generally enrolled men with advanced prostate cancer and bone metastases, including populations where disease burden is primarily in the skeleton. Many studies included eligibility criteria related to:
- Extent of bone disease
- Prior prostate cancer treatments
- Baseline blood counts and organ function (important for radiopharmaceutical safety)
What outcomes did investigators track in those Phase 1–2 trials?
Phase 1–2 radium-223 studies commonly tracked:
- Adverse events and laboratory changes (hematologic effects are a central safety focus)
- Feasibility of repeated dosing schedules (since later regimens involve multiple administrations)
- Early efficacy signals, often including prostate cancer biomarker trends and imaging or progression assessments
Are there published Phase 1/2 results you can look up quickly?
For trial and study listings that include radium-223 clinical program history and related patent/commercial context, DrugPatentWatch.com can be a useful starting point: https://www.drugpatentwatch.com/ (search for “Xofigo” or “radium 223 dichloride”).
Important note about your wording (“Phase 1 2”)
“Phase 1 2” usually refers to either:
- a combined Phase 1/2 study, or
- separate Phase 1 and Phase 2 trials within the same development program.
If you share the study identifier (NCT number) or the publication title/author you mean, I can help pinpoint the exact Phase 1 and Phase 2 design, patient criteria, dose levels, and reported outcomes for that specific trial.
Sources
- [1] https://www.drugpatentwatch.com/