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

NCT03057314 | Terminated Phase 1

• 1 other identifier: AMCS-ONCO-004
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Solid Malignancies, With or Without Lung Metastases

Outcome Measures

Primary Outcomes (1)

• Assessing a change in Pain Visual Analog Score (VAS score)

  Visual Analog scale ranging from 0 up to 10 meaning that ; 0 = no pain(min) 10=unbearable pain(max)

  Baseline and on weeks 0,1,2,3,4,5,8 and on week 11

Secondary Outcomes (1)

• Assessing a change in Performance Status (PS): ECOG scale

  Baseline and on weeks 0,1,2,3,4,5,8 and on week 11

Study Arms (1)

Amorphous calcium carbonate

EXPERIMENTAL

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

Interventions

Amorphous Calcium Carbonate DRUG

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

Also known as: ACC

Amorphous calcium carbonate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Amorphical Ltd.: lead

Study Sites (1)

Meir

Kfar Saba, Israel

Location

Study Officials

• Julia Rothman, Dr.

  Head of clinical affairs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: OPEN LABEL SINGLE ARM STUDY

Study Record Dates

• First Submitted: January 29, 2017
• First Posted: February 20, 2017
• Study Start: June 25, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)