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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03057314
Recruitment Status : Recruiting
First Posted : February 20, 2017
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Solid Malignancies, With or Without Lung Metastases Drug: Amorphous Calcium Carbonate Phase 1

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: OPEN LABEL SINGLE ARM STUDY
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 25, 2017
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
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
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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057314


Contacts
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Contact: Julia Rothman, Dr. +972-8-9584384 julia@amorphical.com

Locations
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Israel
Meir Recruiting
Kfar Saba, Israel
Contact: Maya Gotfried, Dr         
Sponsors and Collaborators
Amorphical Ltd.
Investigators
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Study Director: Julia Rothman, Dr. Head of clinical affairs
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Responsible Party: Amorphical Ltd.
ClinicalTrials.gov Identifier: NCT03057314    
Other Study ID Numbers: AMCS-ONCO-004
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Calcium Carbonate
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents