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

NCT02864784 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-02-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Amorphical Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-30
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02864784 on ClinicalTrials.gov