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Trial record 5 of 7 for:    Amorphous calcium carbonate

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

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ClinicalTrials.gov Identifier: NCT03057314
Recruitment Status : Unknown
Verified April 2019 by Amorphical Ltd..
Recruitment status was:  Recruiting
First Posted : February 20, 2017
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Amorphical Ltd.

Tracking Information
First Submitted Date  ICMJE January 29, 2017
First Posted Date  ICMJE February 20, 2017
Last Update Posted Date April 2, 2019
Actual Study Start Date  ICMJE June 25, 2017
Estimated Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
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 ]
Visual Analog scale ranging from 0 up to 10 meaning that ; 0 = no pain(min) 10=unbearable pain(max)
Original Primary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
Assessing a change in Pain VAS score [ Time Frame: VAS scale will be measured at baseline and on weeks 0,1,2,3,4,5,8 and on week 11 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2019)
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 ]
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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2017)
Assessing a change in Performance Status (PS) [ Time Frame: ECOG scale will be measured at baseline and on weeks 0,1,2,3,4,5,8 and on week 11 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Function,Welfare of Late-stage Cancer Subjects by ACC
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
OPEN LABEL SINGLE ARM STUDY
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Malignancies, With or Without Lung Metastases
Intervention  ICMJE 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
Other Name: ACC
Study Arms  ICMJE Experimental: 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
Intervention: Drug: Amorphous Calcium Carbonate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 15, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 31, 2019
Estimated Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

  1. Males and females, age >18 years
  2. Signed the informed consent
  3. Late Stage Histologically proven advanced solid tumours for which no standard curative therapy exist who failed or refused anti-cancer treatment
  4. 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
  5. Performance Status: ECOG 0-3/ Karnofsky performance status >50
  6. Life Expectancy : about 2 months
  7. Hormonal therapy is allowed if needed
  8. Patient is on conservative treatment for relieving his symptoms
  9. Subjects within normal range of serum-corrected albumin calcium (between 7.0-10.5 mg/dl)
  10. 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

  11. 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:

    1. 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.
    2. 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.

  12. 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.
  13. Subjects receiving Denosumab or bisphosphonates are eligible. Denosumab or bisphosphonates can be administered during the study to alleviate bone metastasis pain.
  14. Negative Pregnancy Test.

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03057314
Other Study ID Numbers  ICMJE AMCS-ONCO-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Amorphical Ltd.
Study Sponsor  ICMJE Amorphical Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Julia Rothman, Dr. Head of clinical affairs
PRS Account Amorphical Ltd.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP