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

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

Study Description

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)

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Amorphous calcium carbonate; The investigation product will include: ACC tablets, containing 200 mg elemental calcium; 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: ACC tablets, containing 200 mg elemental calcium; 1% ACC (i.e. 0.3% calcium) + 5 mL Water for Injection, as a sterile suspension; Other Name: ACC

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

Israel

Meir; Recruiting

Kfar Saba, Israel

Contact: Maya Gotfried, Dr

Sponsors and Collaborators

Amorphical Ltd.

Investigators

• Study Director: Julia Rothman, Dr.; Head of clinical affairs

More Information

• Responsible Party: Amorphical Ltd.
• ClinicalTrials.gov Identifier: NCT03057314
• Other Study ID Numbers: AMCS-ONCO-004
• First Posted: February 20, 2017
• Last Update Posted: April 2, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neoplasms; Calcium Carbonate; Calcium; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Antacids; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents