Investigating the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC) on the Treatment of Subjects With CRPC

Summary

Studies objectives: To evaluate the safety, tolerability and efficacy of ACC given in combination with ZA or with Denosumab as compared to placebo given with ZA or with Denosumab as outline below: * Safety and Tolerability: * Adverse events (AEs) and serious AEs * Safety laboratory measurements * Hypercalcemic and hypercalciuric episodes * Treatment withdrawal due to AEs and overall Efficacy: * Skeletal Related Events (SREs) * Measurable and evaluable disease progression * Progression Free Survival (PFS) * Pain assessment via the VAS scale

Timeline

Start

2022-06

Primary completion

2023-12

Completion

2023-12

Outcome

Outcome not reported

Stopped: “Budget”

Drugs

Indications