NCT03057314

Improving Function,Welfare of Late-stage Cancer Subjects by ACC

Exploratory, Open Label Study to Improve Function and Welfare of Late-stage Cancer Subjects by Amorphous Calcium Carbonate (ACC) Treatment, Administered Orally and Concomitantly With Inhalation

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Amorphical Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To improve the function and welfare of late stage solid cancer subjects by: * enabling subjects to benefit from a potentially promising drug under development * assessing initial evidence of improvement in Pain VAS score * assessing initial improvement in Performance Status (PS) * assessing initial improvement in oxygen saturation whenever it is feasible

Detailed description

To improve the function and welfare of late stage solid cancer subjects by: * enabling subjects to benefit from a potentially promising drug under development * assessing initial evidence of improvement in Pain VAS score * assessing initial improvement in Performance Status (PS) * assessing improvement in oxygen saturation whenever it is feasible/ dyspnea measurement (Modified Borg Scale)

Conditions

• Solid Malignancies, With or Without Lung Metastases

Interventions

Type	Name	Description
DRUG	Amorphous Calcium Carbonate	Subjects will be administered with: 1. ACC tablets, containing 200 mg elemental calcium 2. 1% ACC (i.e. 0.3% calcium) + 5 mL Water for Injection, as a sterile suspension

Timeline

• Start date: 2017-06-25
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2017-02-20
• Last updated: 2024-02-28

Locations

1 site across 1 country: Israel