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

Phase 1

Terminated

• Conditions: Solid Malignancies, With or Without Lung Metastases
• Interventions: Drug: Amorphous Calcium Carbonate

• Registration Number: NCT03057314
• Lead Sponsor: Amorphical Ltd.

Brief 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)

Study Timeline

• Study First Submitted: 2017-01-29
• Study First Submitted QC: 2017-02-15
• Study First Posted: 2017-02-20
• Study Start: 2017-06-25
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-25
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

1. Concurrent treatment with acute anti-cancer therapy
2. Hypercalcemia (serum calcium concentration > 12.0 mg/dL)
3. Clinical Significant Cardiovascular Disease
4. Known alcohol or drug abuse
5. Any psychiatric condition that would prohibit understanding or rendering of Informed Consent
6. Active Participation in Clinical Trial in the last 2 weeks prior to inclusion
7. Brain metastases or spinal cord compression unless asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment.
8. Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Amorphous calcium carbonate	Amorphous Calcium Carbonate	The investigation product will include: 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

Primary Outcome Measures

Name	Time	Method
Assessing a change in Pain Visual Analog Score (VAS score)	Baseline and on weeks 0,1,2,3,4,5,8 and on week 11	Visual Analog scale ranging from 0 up to 10 meaning that ; 0 = no pain(min) 10=unbearable pain(max)

Secondary Outcome Measures

Name	Time	Method
Assessing a change in Performance Status (PS): ECOG scale	Baseline and on weeks 0,1,2,3,4,5,8 and on week 11	assessing the patients improvement or not in their performance status;0 Fully active, able to carry on all pre-disease performance without restriction.1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.2 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours.3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours 4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair.5 Dead

Trial Locations

Locations (1)

Meir; 🇮🇱 Kfar Saba, Israel