Clinical trial NCT03057314: Improving Function,Welfare of Late-stage Cancer Subjects by ACC
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Solid Malignancies, With or Without Lung Metastases
Lead sponsor: Amorphical Ltd.
Sponsor class: INDUSTRY
First posted: 2017-02-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: OPEN LABEL SINGLE ARM STUDY
Primary purpose: TREATMENT

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)

Eligibility 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

Primary outcomes:
measure: Assessing a change in Pain Visual Analog Score (VAS score)
timeFrame: Baseline and on weeks 0,1,2,3,4,5,8 and on week 11
Secondary outcomes:
measure: Assessing a change in Performance Status (PS): ECOG scale
timeFrame: Baseline and on weeks 0,1,2,3,4,5,8 and on week 11
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Meir
Study officials:
affiliation: Head of clinical affairs
name: Julia Rothman, Dr.
role: STUDY_DIRECTOR
References: