- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Julia Rothman, Dr.
- Phone Number: +972-8-9584384
- Email: julia@amorphical.com
Study Locations
-
-
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Kfar Saba, Israel
- Meir
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Males and females, age >18 years
- Signed the informed consent
- Late Stage Histologically proven advanced solid tumours for which no standard curative therapy exist who failed or refused anti-cancer treatment
- Subject should not have any illness or condition deemed by the physician to contra-indicate treatment with ACC or may interfere with the assessment of the therapy
- Performance Status: ECOG 0-3/ Karnofsky performance status >50
- Life Expectancy : about 2 months
- Hormonal therapy is allowed if needed
- Patient is on conservative treatment for relieving his symptoms
- Subjects within normal range of serum-corrected albumin calcium (between 7.0-10.5 mg/dl)
Acceptable haematology and biochemistry variables:
WBC ≥3000/mm3 Absolute Neutrophil count ≥ 1500 /mm3 Platelet Count ≥ 100,000/mm3 Hemoglobin ≥ 9 g/dL Bilirubin ≤ 1.5 x ULN ALT and AST ≤ 2.5 x ULN; for patients with hepatic metastases, ALT and AST ≤ 5 x ULN PT/PTT ≤ 1.5 ULN
Subjects should have sufficient Vitamin D levels upon study entry, which is defined as 25(OH)D serum level >20 ng/mL (50 nmol/L) according to a document composed by the Food and Nutrition Board of the Institute of Medicine, USA. If the subject is Vitamin D insufficient or deficient, then a loading dose of Vitamin D3 will be administered during subject's enrollment or during the study as follows:
- If the serum 25(OH)D level is 12-20 ng/mL (30-50 nmol/L) then a loading oral dose of 50,000 IU of Vitamin D3 should be administered twice with 3-5 days in between the doses.
- If the serum 25(OH)D level is ≤ 12 ng/mL (30 nmol/L), then a loading oral dose of 50,000 IU of Vitamin D3 will be administered three times with 3-5 days in between the doses. Serum 25(OH)D levels will be checked 1-2 weeks following the last loading.
Nevertheless, if levels of vitamin D levels will not be within the normal range after adjustment efforts, patients will not excluded from the study.
- Regardless of Vitamin D levels, all subjects will receive a daily maintenance dose of 1000 IU Vitamin D3, which should be taken in the morning with breakfast.
- Subjects receiving Denosumab or bisphosphonates are eligible. Denosumab or bisphosphonates can be administered during the study to alleviate bone metastasis pain.
- Negative Pregnancy Test.
Exclusion Criteria:
- Concurrent treatment with acute anti-cancer therapy
- Hypercalcemia (serum calcium concentration > 12.0 mg/dL)
- Clinical Significant Cardiovascular Disease
- Known alcohol or drug abuse
- Any psychiatric condition that would prohibit understanding or rendering of Informed Consent
- Active Participation in Clinical Trial in the last 2 weeks prior to inclusion
- 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.
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Amorphous calcium carbonate
The investigation product will include:
|
Subjects will be administered with:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing a change in Pain Visual Analog Score (VAS score)
Time Frame: Baseline and on weeks 0,1,2,3,4,5,8 and on week 11
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Visual Analog scale ranging from 0 up to 10 meaning that ; 0 = no pain(min) 10=unbearable pain(max)
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Baseline and on weeks 0,1,2,3,4,5,8 and on week 11
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessing a change in Performance Status (PS): ECOG scale
Time Frame: Baseline and on weeks 0,1,2,3,4,5,8 and on week 11
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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
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Baseline and on weeks 0,1,2,3,4,5,8 and on week 11
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Julia Rothman, Dr., Head of clinical affairs
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AMCS-ONCO-004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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