Solid Malignancies, With or Without Lung MetastasesPhase 1NCT03057314
Improving Function,Welfare of Late-stage Cancer Subjects by ACC
A Phase 1 study testing Amorphous Calcium Carbonate in people with Solid Malignancies, With or Without Lung Metastases, run by Amorphical Ltd. at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Malignancies, With or Without Lung Metastases
- What is being tested?
- Amorphous Calcium Carbonate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Jun 2017to 31 Dec 2019
- 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 years and older
- 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 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
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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.
- Nevertheless, if levels of vitamin D levels will not be within the normal range after adjustment efforts, patients will not excluded from the study.
- 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.
- 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 (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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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)
- Being tested
- Amorphous Calcium Carbonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amorphous Calcium CarbonateDrug
Also called ACC
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Amorphous Calcium Carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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
Measured: Baseline and on weeks 0,1,2,3,4,5,8 and on week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start25 Jun 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: Slow recreuitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Malignancies, With or Without Lung MetastasesStudies 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
- Model description
- OPEN LABEL SINGLE ARM STUDY
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorphical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Julia Rothman, Dr., Study director, Head of clinical affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057314
- Sponsor's protocol ID
- AMCS-ONCO-004
- Status last verified
- Feb 2024
- First submitted
- 29 Jan 2017
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- 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
- ClinicalTrials.gov ID
- NCT03057314
- Acronym / sponsor ID
- AMCS-ONCO-004
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recreuitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Amorphical Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 20 Feb 2017 (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.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- OPEN LABEL SINGLE ARM STUDY
| Arm | Type | Receives |
|---|---|---|
| Amorphous calcium carbonate | Experimental | Drug: Amorphous Calcium CarbonateThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 CarbonateAlso: ACCSubjects 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 | Drug | Amorphous calcium carbonate |
Primary outcome
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)
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Slow recreuitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Julia Rothman, Dr. study director
Head of clinical affairs
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 in people with Solid Malignancies, With or Without Lung Metastases, 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 18 inclusion and 8 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 recreuitment). 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?
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). 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.