NCT02864784

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

A Prospective, Multicenter, Randomized, Placebo-Controlled, Two-armed, Double-blind Pilot Study to Evaluate the Safety, Tolerability and Efficacy of ACC vs. Placebo for the Treatment of Subjects With Castrate Resistant Prostate Cancer With Bone Metastasis

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Amorphical Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Castrate Resistant Prostate Cancer With Bone Metastasis

Interventions

Type	Name	Description
DRUG	Amorphous calcium carbonate	Subjects in this arm of the study will receive standard treatment with ZA or Denosumab (4 mg once every 4 weeks for ZA and 120mg (1.7ml injection) every 4 weeks for Denosumab) as well as AMOR-1 tablets, containing 200 mg elemental calcium per tablet, individually titrated up to the maximum level which does not induce grade 2 hypercalcemia.
OTHER	Placebo	microcrystalline cellulose

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2016-08-12
• Last updated: 2024-02-28

Locations

1 site across 1 country: Israel