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

• Status: Unknown status
• Trial end date: 2017-04-01

Summary

Studies objectives:

To evaluate the safety, tolerability and efficacy of AMOR-1 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

• Phase: Phase 1

Details

• Lead Sponsor: Amorphical Ltd.
• Treatments: Calcium; Calcium Carbonate; Calcium, Dietary; Denosumab