OncologyPhase 1ONCO-004-1NCT03582280
The Effect of Amorphous Calcium Carbonate (ACC) Treatment on Function and Welfare in Late-stage Solid Cancer Subjects
A Phase 1 study testing Amorphous Calcium Carbonate (ACC) - Amor in people with Oncology, run by Amorphical Ltd. at 1 site in Israel.
Trial summary
An exploratory open label study to improve the function and welfare of late-stage solid cancer subjects (with or without lung involvement) who failed or refused anti-cancer treatment by ACC treatment, administered orally and concomitantly by inhalation. Read more about this study
- Who is it for?
- Ages 18 to 119 years
- Conditions the study is for
- Oncology
- What is being tested?
- Amorphous Calcium Carbonate (ACC) - Amor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteIsrael
- Study dates
- 18 Jul 2018to 31 Oct 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 119 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, age 18 years +
- Signed the informed consent
- Late Stage Histologically proven advanced solid tumours for which no standard of care therapy exist or 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 : at least 2 months
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- 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.
- Subjects receiving Denosumab or bisphosphonates are eligible. Denosumab or bisphosphonates can be administered during the study to alleviate bone metastasis pain.
- Negative Pregnancy Test.
Who cannot join
- Concurrent treatment with acute anti-cancer therapy
- Hypercalcemia or previous consistent reporting of 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
- Active Participation in Clinical Trial in the last 2 weeks prior to inclusion
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- 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.
- Nephrolithiasis
- Pregnancy
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Improve the Function and Welfare of Late-stage Solid Cancer Subjects by Amorphous Calcium Carbonate (ACC) Treatment, Administered Orally and Concomitantly With Inhalation
An exploratory open label study to improve the function and welfare of late-stage solid cancer subjects (with or without lung involvement) who failed or refused anti-cancer treatment by ACC treatment, administered orally and concomitantly by inhalation.
The following measures will be evaluated: improvement of pain, performance status, dyspnea measurement (Modified Borg Scale)/ oxygen saturation (if applicable) and overall survival.
Read more
The subjects' medical charts will be reviewed for their eligibility including the following: medical history, prior cancer treatments, pathologic diagnosis of cancer, and CT/Chest X-ray results. Assessment of prior and concurrent medication use, physician evaluation of patient status, and measurement of Albumin Corrected Serum Calcium level (to be done at baseline and prior to dose escalation, so that results are available prior to the visit) will be performed prior to each dose escalation; in addition, vital signs, ECOG/Karnofsky performance status and VAS pain assessments will be recorded at each visit as well. CT test will be executed during the study period: at baseline, week 12 and week 24 visits in order to assess progression free survival by CT.
The tests during the visits will be performed by a physician/nurse. Each subject will receive individual doses of AMOR-powder by escalating doses up to 1,800 mg of ACC powder per day (Amor powder administration will be continuous along the day - each eppendorf every two hours). Patients who will not be able to swallow the powder, will receive similar doses of ACC in tablets.
In addition, subject will inhale 1% ACC in 8 ml suspension, for inhalation three times a day.
Subject's functionality will be assessed by serially determining ECOG/Karnofsky performance status. Subject's progression free survival will be assessed by CT to evaluate tumor response to treatment.
Read the detailed description
Subjects diagnosed with late stage solid cancer (with or without lung involvement) who failed or refused anti-cancer treatment will be enrolled and administered with both: AMOR powder up to 1800 mg daily and AMOR Inhaled Double Pack 1% ACC in 8 ml suspension - three times a day.
Starting Doses:
1200 mg of AMOR powder (will be administered continuously along the day, each Eppendorf every two hours) scaled up by 200 mg every week until maximum dose of 1,800 mg. Patients who will not be able to swallow the powder, will receive similar doses of ACC tablets.
ACC Amor Inhaled Double Pack; 1% ACC in 8 ml suspension - for inhalation three times a day.
Screening hospital visit:
- Inform consent
- Subjects' medical charts will be reviewed for medical history, prior cancer treatments
- Eligibility Criteria assessment: adherence with inclusion/exclusion criteria
- Pathologic diagnosis of cancer and CT/Chest X-Ray will be obtained from the patient's charts as needed.
- Concomitant medications
- Physician evaluation of patient status
- Lab: Hematology, Blood chemistry, Albumin Corrected Serum Calcium will be performed prior to first dose (blood to be drawn in the morning before breakfast)
- Serum 25-hydroxy-vitamin D, i.e. 25(OH)D
- Pain VAS score scale
- ECOG/Karnofsky performance status
- Vital signs (blood pressure and heart rate - supine, respiration rate (RR), oral body temperature)
- Weight
- Oxygen saturation as determined by pulse oximeter/ Dyspnea measurement (Modified Borg Scale)
- All women of child-bearing potential will have a pregnancy test
- Once eligibility criteria are met, subject will undergo CT imaging during screening or baseline or week 1 visit.
- Following CT, RECIST ver. 1.1 Once eligibility criteria are met, subject will initiate treatment of ACC. Vitamin D levels will be re-examined and recorded.
Baseline (Week 0) hospital visit:
- Eligibility Criteria assessment: adherence with inclusion/exclusion criteria
- Subjects' medical charts will be reviewed for medical history, prior cancer treatments
- Concomitant medications
- Lab: Hematology, Blood chemistry, Albumin Corrected Serum Calcium will be performed prior to first dose (blood to be drawn in the morning before breakfast; must have calcium level measurement before escalation)
- Serum 25-hydroxy-vitamin D, i.e. 25(OH)D
- VAS once daily
- ECOG/Karnofsky performance status
- Vital signs (blood pressure and heart rate - supine, respiration rate (RR), oral body temperature)
- Oxygen saturation as determined by pulse oximeter/ Dyspnea measurement (Modified Borg Scale)
- All women of child-bearing potential will have a pregnancy test
- CT imaging to evaluate tumor size and volume at study initiation, if test was not performed between the screening and baseline visit.
- RECIST ver. 1.1 (if was not performed during screening visit).
First ACC Dose:
- ACC Per Os (PO) 1200 mg x1 (i.e. 6 AMOR powder Eppendorf's daily, (Amor powder administration will be continuous along the day, i.e. each Eppendorf will be administered every two hours). Patients who will not be able to swallow the powder, will receive similar doses of ACC tablets.
- ACC 1% in 8 mL suspension- inhalation for three times a day.
Week 1 (+/- 2 days range) hospital visit:
- Albumin Corrected Serum Calcium will be performed prior to dose escalation (blood to be draw in the morning before breakfast)
- Dose escalation of ACC PO by 200 mg for a total daily dose of 1400 mg (Amor powder administration will be continuous along the day)
- ACC 1% in 8 mL suspension- inhalation for three times a day.
- Concomitant medications
- VAS once daily
- Oxygen saturation as determined by pulse oximeter/ Dyspnea measurement (Modified Borg Scale)
- CT imaging to evaluate tumor size and volume at study initiation, if test was not performed during screening visit.
- RECIST ver. 1.1 (if was not performed during baseline visit).
- AEs/DLTs
Week 2 (+/- 2 days range) hospital visit:
- Albumin Corrected Serum Calcium will be performed prior to dose escalation (blood to be draw in the morning before breakfast)
- Dose escalation of ACC PO by 200 mg for a total daily dose of 1600 mg (Amor powder continuous administration along the day)
- ACC 1% in 8 mL suspension- inhalation for three times a day.
- Concomitant medications
- VAS once daily
- Oxygen saturation as determined by pulse oximeter/ Dyspnea measurement (Modified Borg Scale)
- AEs/DLTs
Week 3 (+/- 2 days range) hospital visit/ home visit:
- Albumin Corrected Serum Calcium will be performed prior to dose escalation (blood to be draw in the morning before breakfast)
- Dose escalation of ACC PO by 200 mg for a total daily dose 1800 mg (Amor powder administration will be continuous along the day)
- ACC 1% in 8 mL suspension- inhalation for three times a day.
- Concomitant medications
- VAS once daily
- ECOG/Karnofsky performance status
- Oxygen saturation as determined by pulse oximeter/ Dyspnea measurement (Modified Borg Scale)
- AEs/DLTs
Treatment Maintenance:
Week 6 (+/- 2 days range) hospital visit:
- ACC PO administration will be continuous along the day at the final patient dosage level
- Albumin Corrected Serum Calcium
- ACC 1% in 8 mL suspension- inhalation for three times a day.
- Concomitant medications
- Physician evaluation of patient status
- Hematology
- Blood chemistry
- ECOG/Karnofsky performance status
- Pain VAS scale score
- Oxygen saturation as determined by pulse oximeter/ Dyspnea measurement (Modified Borg Scale)
- AEs/DLTs
Week 12 (+/- 2 days range) hospital visit:
- ACC PO administration will be continuous along the day at the final patient dosage level
- Albumin Corrected Serum Calcium
- ACC 1% in 8 mL suspension- inhalation for three times a day.
- Concomitant medications
- Physician evaluation of patient status
- Hematology
- Blood chemistry
- CT imaging to evaluate tumor size and volume
- RECIST ver. 1.1
- ECOG/Karnofsky performance status
- Pain VAS scale score
- Oxygen saturation as determined by pulse oximeter/ Dyspnea measurement (Modified Borg Scale)
- AEs/DLTs
Week 18 (+/- 2 days range) hospital visit:
- ACC PO administration will be continuous along the day at the final patient dosage level
- Albumin Corrected Serum Calcium
- ACC 1% in 8 mL suspension- inhalation for three times a day.
- Concomitant medications
- Physician evaluation of patient status
- Hematology
- Blood chemistry
- ECOG/Karnofsky performance status
- Pain VAS scale score
- Oxygen saturation as determined by pulse oximeter/ Dyspnea measurement (Modified Borg Scale)
- AEs/DLTs
Week 24 Termination visit (+/- 2 days range) hospital visit:
- ACC PO administration will be continuous along the day at the final patient dosage level
- Albumin Corrected Serum Calcium
- ACC 1% in 8 mL suspension- inhalation for three times a day.
- Concomitant medications
- Physician evaluation of patient status
- Hematology
- Blood chemistry
- CT imaging to evaluate tumor size and volume at study endpoint
- RECIST ver. 1.1
- ECOG/Karnofsky performance status
- Pain VAS scale score
- Oxygen saturation as determined by pulse oximeter/ Dyspnea measurement (Modified Borg Scale)
- AEs/DLTs A decision regarding a follow up period will be made at the discretion of the investigator based on the subject's condition together with subject's agreement. Once agree, study drugs will be dispensed for the follow up period. The follow up period will be prolonged up to 6 months following study termination.
- Conditions
- Oncology
- Being tested
- Amorphous Calcium Carbonate (ACC) - Amor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amorphous Calcium Carbonate (ACC) - AmorDrug
Amor Powder is composed of Amorphous Calcium Carbonate and is administered oral Amor Inhaled Double Pack is composed of 1% ACC in solution and is administered by inhalation
| Study group | Role | What they receive |
|---|---|---|
| Amorous Calcium Carbonate (ACC) - Amor | Experimental | The investigational product will include:
1. Amor powder, each eppendorf contains 200mg Calcium
2. Amor Inhaled Double Pack - 1% ACC in 8 ml suspension Receives: Drug: Amorphous Calcium Carbonate (ACC) - Amor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS) score for pain
Assessing a change in Pain VAS score The scale is between 0-10. 0 is a score for no pain 5 is a score for moderate pain 10 is a score for unbearable pain
Measured: week 0, week 1, week 2, week 3, week 6, week 12, week 18, week 24
ECOG Performance status (PS)
Assessing a change in PS Grade 0 - Fully active, able to carry on all pre-disease performance without restriction Grade1 - 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 Grade 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours Grade 3 - Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours Grade 4 - Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair Grade 5 - Dead
Measured: week 0, week 1, week 2, week 3, week 6, week 12, week 18, week 24
Oxygen saturation
Assessing a change in oxygen saturation Normal pulse oximeter readings usually range from 95 to 100 percent. Values under 90 percent are considered low.
Measured: week 0, week 1, week 2, week 3, week 6, week 12, week 18, week 24
Progression Free Survival
Assessing a change from baseline in tumor's growth and size by using CT
Measured: week 0, week 12, week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start18 Jul 2018
- Primary completion30 Jun 2022
- Study completion31 Oct 2022
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorphical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582280
- Sponsor's protocol ID
- AMCS-ONCO-004-1
- Acronym
- ONCO-004-1
- Status last verified
- Feb 2024
- First submitted
- 19 Jun 2018
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Improve the Function and Welfare of Late-stage Solid Cancer Subjects by Amorphous Calcium Carbonate (ACC) Treatment, Administered Orally and Concomitantly With Inhalation
- ClinicalTrials.gov ID
- NCT03582280
- Acronym / sponsor ID
- ONCO-004-1 / AMCS-ONCO-004-1
- Conditions
- Oncology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Amorphical Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An exploratory open label study to improve the function and welfare of late-stage solid cancer subjects (with or without lung involvement) who failed or refused anti-cancer treatment by ACC treatment, administered orally and concomitantly by inhalation.
The following measures will be evaluated: improvement of pain, performance status, dyspnea measurement (Modified Borg Scale)/ oxygen saturation (if applicable) and overall survival.
The subjects' medical charts will be reviewed for their eligibility including the following: medical history, prior cancer treatments, pathologic diagnosis of cancer, and CT/Chest X-ray results. Assessment of prior and concurrent medication use, physician evaluation of patient status, and measurement of Albumin Corrected Serum Calcium level (to be done at baseline and prior to dose escalation, so that results are available prior to the visit) will be performed prior to each dose escalation; in addition, vital signs, ECOG/Karnofsky performance status and VAS pain assessments will be recorded at each visit as well. CT test will be executed during the study period: at baseline, week 12 and week 24 visits in order to assess progression free survival by CT.
The tests during the visits will be performed by a physician/nurse. Each subject will receive individual doses of AMOR-powder by escalating doses up to 1,800 mg of ACC powder per day (Amor powder administration will be continuous along the day - each eppendorf every two hours). Patients who will not be able to swallow the powder, will receive similar doses of ACC in tablets.
In addition, subject will inhale 1% ACC in 8 ml suspension, for inhalation three times a day.
Subject's functionality will be assessed by serially determining ECOG/Karnofsky performance status. Subject's progression free survival will be assessed by CT to evaluate tumor response to treatment.
Detailed description
Subjects diagnosed with late stage solid cancer (with or without lung involvement) who failed or refused anti-cancer treatment will be enrolled and administered with both: AMOR powder up to 1800 mg daily and AMOR Inhaled Double Pack 1% ACC in 8 ml suspension - three times a day.
Starting Doses:
1200 mg of AMOR powder (will be administered continuously along the day, each Eppendorf every two hours) scaled up by 200 mg every week until maximum dose of 1,800 mg. Patients who will not be able to swallow the powder, will receive similar doses of ACC tablets.
ACC Amor Inhaled Double Pack; 1% ACC in 8 ml suspension - for inhalation three times a day.
Screening hospital visit:
- Inform consent
- Subjects' medical charts will be reviewed for medical history, prior cancer treatments
- Eligibility Criteria assessment: adherence with inclusion/exclusion criteria
- Pathologic diagnosis of cancer and CT/Chest X-Ray will be obtained from the patient's charts as needed.
- Concomitant medications
- Physician evaluation of patient status
- Lab: Hematology, Blood chemistry, Albumin Corrected Serum Calcium will be performed prior to first dose (blood to be drawn in the morning before breakfast)
- Serum 25-hydroxy-vitamin D, i.e. 25(OH)D
- Pain VAS score scale
- ECOG/Karnofsky performance status
- Vital signs (blood pressure and heart rate - supine, respiration rate (RR), oral body temperature)
- Weight
- Oxygen saturation as determined by pulse oximeter/ Dyspnea measurement (Modified Borg Scale)
- All women of child-bearing potential will have a pregnancy test
- Once eligibility criteria are met, subject will undergo CT imaging during screening or baseline or week 1 visit.
- Following CT, RECIST ver. 1.1 Once eligibility criteria are met, subject will initiate treatment of ACC. Vitamin D levels will be re-examined and recorded.
Baseline (Week 0) hospital visit:
- Eligibility Criteria assessment: adherence with inclusion/exclusion criteria
- Subjects' medical charts will be reviewed for medical history, prior cancer treatments
- Concomitant medications
- Lab: Hematology, Blood chemistry, Albumin Corrected Serum Calcium will be performed prior to first dose (blood to be drawn in the morning before breakfast; must have calcium level measurement before escalation)
- Serum 25-hydroxy-vitamin D, i.e. 25(OH)D
- VAS once daily
- ECOG/Karnofsky performance status
- Vital signs (blood pressure and heart rate - supine, respiration rate (RR), oral body temperature)
- Oxygen saturation as determined by pulse oximeter/ Dyspnea measurement (Modified Borg Scale)
- All women of child-bearing potential will have a pregnancy test
- CT imaging to evaluate tumor size and volume at study initiation, if test was not performed between the screening and baseline visit.
- RECIST ver. 1.1 (if was not performed during screening visit).
First ACC Dose:
- ACC Per Os (PO) 1200 mg x1 (i.e. 6 AMOR powder Eppendorf's daily, (Amor powder administration will be continuous along the day, i.e. each Eppendorf will be administered every two hours). Patients who will not be able to swallow the powder, will receive similar doses of ACC tablets.
- ACC 1% in 8 mL suspension- inhalation for three times a day.
Week 1 (+/- 2 days range) hospital visit:
- Albumin Corrected Serum Calcium will be performed prior to dose escalation (blood to be draw in the morning before breakfast)
- Dose escalation of ACC PO by 200 mg for a total daily dose of 1400 mg (Amor powder administration will be continuous along the day)
- ACC 1% in 8 mL suspension- inhalation for three times a day.
- Concomitant medications
- VAS once daily
- Oxygen saturation as determined by pulse oximeter/ Dyspnea measurement (Modified Borg Scale)
- CT imaging to evaluate tumor size and volume at study initiation, if test was not performed during screening visit.
- RECIST ver. 1.1 (if was not performed during baseline visit).
- AEs/DLTs
Week 2 (+/- 2 days range) hospital visit:
- Albumin Corrected Serum Calcium will be performed prior to dose escalation (blood to be draw in the morning before breakfast)
- Dose escalation of ACC PO by 200 mg for a total daily dose of 1600 mg (Amor powder continuous administration along the day)
- ACC 1% in 8 mL suspension- inhalation for three times a day.
- Concomitant medications
- VAS once daily
- Oxygen saturation as determined by pulse oximeter/ Dyspnea measurement (Modified Borg Scale)
- AEs/DLTs
Week 3 (+/- 2 days range) hospital visit/ home visit:
- Albumin Corrected Serum Calcium will be performed prior to dose escalation (blood to be draw in the morning before breakfast)
- Dose escalation of ACC PO by 200 mg for a total daily dose 1800 mg (Amor powder administration will be continuous along the day)
- ACC 1% in 8 mL suspension- inhalation for three times a day.
- Concomitant medications
- VAS once daily
- ECOG/Karnofsky performance status
- Oxygen saturation as determined by pulse oximeter/ Dyspnea measurement (Modified Borg Scale)
- AEs/DLTs
Treatment Maintenance:
Week 6 (+/- 2 days range) hospital visit:
- ACC PO administration will be continuous along the day at the final patient dosage level
- Albumin Corrected Serum Calcium
- ACC 1% in 8 mL suspension- inhalation for three times a day.
- Concomitant medications
- Physician evaluation of patient status
- Hematology
- Blood chemistry
- ECOG/Karnofsky performance status
- Pain VAS scale score
- Oxygen saturation as determined by pulse oximeter/ Dyspnea measurement (Modified Borg Scale)
- AEs/DLTs
Week 12 (+/- 2 days range) hospital visit:
- ACC PO administration will be continuous along the day at the final patient dosage level
- Albumin Corrected Serum Calcium
- ACC 1% in 8 mL suspension- inhalation for three times a day.
- Concomitant medications
- Physician evaluation of patient status
- Hematology
- Blood chemistry
- CT imaging to evaluate tumor size and volume
- RECIST ver. 1.1
- ECOG/Karnofsky performance status
- Pain VAS scale score
- Oxygen saturation as determined by pulse oximeter/ Dyspnea measurement (Modified Borg Scale)
- AEs/DLTs
Week 18 (+/- 2 days range) hospital visit:
- ACC PO administration will be continuous along the day at the final patient dosage level
- Albumin Corrected Serum Calcium
- ACC 1% in 8 mL suspension- inhalation for three times a day.
- Concomitant medications
- Physician evaluation of patient status
- Hematology
- Blood chemistry
- ECOG/Karnofsky performance status
- Pain VAS scale score
- Oxygen saturation as determined by pulse oximeter/ Dyspnea measurement (Modified Borg Scale)
- AEs/DLTs
Week 24 Termination visit (+/- 2 days range) hospital visit:
- ACC PO administration will be continuous along the day at the final patient dosage level
- Albumin Corrected Serum Calcium
- ACC 1% in 8 mL suspension- inhalation for three times a day.
- Concomitant medications
- Physician evaluation of patient status
- Hematology
- Blood chemistry
- CT imaging to evaluate tumor size and volume at study endpoint
- RECIST ver. 1.1
- ECOG/Karnofsky performance status
- Pain VAS scale score
- Oxygen saturation as determined by pulse oximeter/ Dyspnea measurement (Modified Borg Scale)
- AEs/DLTs A decision regarding a follow up period will be made at the discretion of the investigator based on the subject's condition together with subject's agreement. Once agree, study drugs will be dispensed for the follow up period. The follow up period will be prolonged up to 6 months following study termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amorous Calcium Carbonate (ACC) - Amor | Experimental | Drug: Amorphous Calcium Carbonate (ACC) - AmorThe investigational product will include: 1. Amor powder, each eppendorf contains 200mg Calcium 2. Amor Inhaled Double Pack - 1% ACC in 8 ml suspension |
Who may qualify
- Ages
- 18 to 119 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Males and females, age 18 years +
- Signed the informed consent
- Late Stage Histologically proven advanced solid tumours for which no standard of care therapy exist or 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
Key exclusion criteria (10 listed)
- Concurrent treatment with acute anti-cancer therapy
- Hypercalcemia or previous consistent reporting of 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amorphous Calcium Carbonate (ACC) - AmorAmor Powder is composed of Amorphous Calcium Carbonate and is administered oral Amor Inhaled Double Pack is composed of 1% ACC in solution and is administered by inhalation | Drug | Amorous Calcium Carbonate (ACC) - Amor |
Primary outcome
Visual Analogue Scale (VAS) score for pain
Time frame: week 0, week 1, week 2, week 3, week 6, week 12, week 18, week 24
Assessing a change in Pain VAS score The scale is between 0-10. 0 is a score for no pain 5 is a score for moderate pain 10 is a score for unbearable pain
ECOG Performance status (PS)
Time frame: week 0, week 1, week 2, week 3, week 6, week 12, week 18, week 24
Assessing a change in PS Grade 0 - Fully active, able to carry on all pre-disease performance without restriction Grade1 - 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 Grade 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours Grade 3 - Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours Grade 4 - Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair Grade 5 - Dead
Oxygen saturation
Time frame: week 0, week 1, week 2, week 3, week 6, week 12, week 18, week 24
Assessing a change in oxygen saturation Normal pulse oximeter readings usually range from 95 to 100 percent. Values under 90 percent are considered low.
Progression Free Survival
Time frame: week 0, week 12, week 24
Assessing a change from baseline in tumor's growth and size by using CT
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Enrolling by invitationPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amorphous Calcium Carbonate (ACC) - Amor in people with Oncology, run by Amorphical Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) score for pain (time frame: week 0, week 1, week 2, week 3, week 6, week 12, week 18, week 24). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.