Castrate Resistant Prostate Cancer With Bone MetastasisPhase 1NCT02864784

Investigating the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC) on the Treatment of Subjects With CRPC

A Phase 1 study testing Amorphous calcium carbonate in people with Castrate Resistant Prostate Cancer With Bone Metastasis, run by Amorphical Ltd. at 1 site in Israel.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Studies objectives: To evaluate the safety, tolerability and efficacy of ACC given in combination with ZA or with Denosumab as compared to placebo given with ZA or with Denosumab as outline below: Safety and Tolerability: Adverse events (AEs) and serious AEs Safety laboratory measurements Hypercalcemic and… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Castrate Resistant Prostate Cancer With Bone Metastasis
What is being tested?: Amorphous calcium carbonate
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 1 siteIsrael
Study dates: Jun 2022to Dec 2023
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

Age > 18 year
Histologic proof of Castrate Resistant Prostate Cancer with Bone Metastasis
Systemic steroids are only allowed if needed for hormonal therapy
Previous radiation therapy must have been completed more than four weeks prior to enrollment into this study, unless subjects are under radiotherapy as a rescue therapy. Subjects must have recovered from all side effects.
The last dose of chemotherapy must have been completed at least four weeks prior to enrollment into this study, and subjects must have recovered from all side effects.
Subjects must have a performance status of 0-2 by the ECOG Scale.

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Subjects must have pretreatment (obtained < 7 days prior to treatment) granulocyte count of > 2,000/μL, platelet count of > 100,000/μL, WBC > 3,000/μL, hemoglobin ≥ 10.0 g/dL, serum creatinine < 1.5 mg/dL, bilirubin < 1.5 mg/dL, and ALT/AST not more than 3x the upper limit of normal (or not more than 5x if the elevation is due to liver metastases).
Subjects must be normo-calcemic upon study entry.
Subjects must be Vitamin D sufficient 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 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.
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.
Estimated life expectancy of > 3 months.
Subjects must be accessible for follow-up.
Written informed consent will be obtained.

Who cannot join

Concurrent treatment with acute anticancer therapy
Hormonal and corticosteroid therapies for Skeletal Related Events are not allowed
Sarcoidosis
Hypercalcemia
Hypophosphatemia
Hypoparathyroidism/Hyperparathyroidism

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Major surgery within 4 weeks of anticipated inception of AMOR-1therapy
Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of therapy
Psychiatric disorders rendering subjects incapable of complying with the requirements of the protocol
Any illness or condition deemed by the investigator to contra-indicate treatment with AMOR-1 or ZA or Denosumab
Hypersensitivity to ZA or Denosumab or Abiraterone acetate or Enzalutamide, or to any bisphosphonates or to any of the following excipients: Mannitol and Sodium citrate.
Active cancer treatment except hormonal

Trial locations and contacts

1 site in 1 country.

Israel1 site

Soroka Medical Center
Beersheba, 84101

Other trials in Israel

About this study

Official title: A Prospective, Multicenter, Randomized, Placebo-Controlled, Two-armed, Double-blind Pilot Study to Evaluate the Safety, Tolerability and Efficacy of ACC vs. Placebo for the Treatment of Subjects With Castrate Resistant Prostate Cancer With Bone Metastasis

Studies objectives:

To evaluate the safety, tolerability and efficacy of ACC given in combination with ZA or with Denosumab as compared to placebo given with ZA or with Denosumab as outline below:

Safety and Tolerability:
Adverse events (AEs) and serious AEs
Safety laboratory measurements
Hypercalcemic and hypercalciuric episodes
Treatment withdrawal due to AEs and overall

Efficacy:

Skeletal Related Events (SREs)
Measurable and evaluable disease progression
Progression Free Survival (PFS)
Pain assessment via the VAS scale

Conditions: Castrate Resistant Prostate Cancer With Bone Metastasis
Being tested: Amorphous calcium carbonate, Placebo

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 in this arm of the study will receive standard treatment with ZA or Denosumab (4 mg once every 4 weeks for ZA and 120mg (1.7ml injection) every 4 weeks for Denosumab) as well as AMOR-1 tablets, containing 200 mg elemental calcium per tablet, individually titrated up to the maximum level which does not induce grade 2 hypercalcemia.
PlaceboOther
microcrystalline cellulose

Study groups in NCT02864784
Study group	Role	What they receive
Amorphous calcium carbonate	Experimental	Subjects in this arm of the study will receive ACC tablets, containing 200 mg elemental calcium in addition to the standard treatment with ZA or Denosumab (4 mg once every 4 weeks for ZA and 120mg (1.7ml injection) every 4 weeks for Denosumab) Receives: Drug: Amorphous calcium carbonate
Placebo	Placebo comparator	Subjects in this arm of the study will receive Placebo tablets in addition to standard treatment with ZA or Denosumab (4 mg once every 4 weeks for ZA and 120mg (1.7ml injection) every 4 weeks for Denosumab) Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in the number of Skeletal Related Events (SREs)
Measured: Bone scan will take place at baseline and week 12

Secondary outcomes (10)

Time from randomization to onset of first SRE.
Measured: Bone scan will be made on baseline and week 12
Proportion of subjects (%) with SREs.
Measured: Bone scan will take place at baseline and week 12
Proportion of subjects (%) with evidence of measureable and evaluable disease progression or SREs.
Measured: Bone scan will take place at baseline and week 12
Progression Free Survival (PFS).
Measured: CT or MRI will be assessed on screening and week 12
Number of subjects that are receiving radiation as a rescue treatment
Measured: An assessment will take place at week 2,4,6,8,10,12 16,20 and 24
Frequency and incidence of treatment emergent adverse events (TEAEs)
Measured: Safety assessment will take place at week 2,4,6,8,10,12 16,20 and 24
Frequency and incidence of serious treatment emergent adverse events (TEAEs).
Measured: Safety assessment will take place at weeks 2,4,6,8,10,12 16,20 and 24
Proportion of subjects (%) with hypercalcemic DLTs.
Measured: Safety assessment will be made at weeks 2,4,6,8,10,12 16,20 and 24
Proportion of subjects (%) with any DLTs.
Measured: Safety assessment will take place at weeks 2,4,6,8,10,12 16,20 and 24
Number of hypercalciuric events.
Measured: Urine calcium levels will be examined by urine tests, taking place at weeks 4,8,12,16,20 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2022Dec 2023

First posted12 Aug 2016 (estimated)
Study startJun 2022 (estimated)
Primary completionDec 2023 (estimated)
Study completionDec 2023 (estimated)

Why it stopped: Budget

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Castrate Resistant Prostate Cancer With Bone MetastasisStudies 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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02864784
Sponsor's protocol ID: AMCS-ONCO-PR-001-CTIL
Status last verified: Feb 2024
First submitted: 2 Aug 2016
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: A Prospective, Multicenter, Randomized, Placebo-Controlled, Two-armed, Double-blind Pilot Study to Evaluate the Safety, Tolerability and Efficacy of ACC vs. Placebo for the Treatment of Subjects With Castrate Resistant Prostate Cancer With Bone Metastasis
ClinicalTrials.gov ID: NCT02864784
Acronym / sponsor ID: AMCS-ONCO-PR-001-CTIL
Conditions: Castrate Resistant Prostate Cancer With Bone Metastasis
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Budget
Enrolment: 0 participants (actual)
Lead sponsor: Amorphical Ltd.Industry (pharma, biotech, devices)
Study start: Jun 2022 (estimated)
Primary completion: Dec 2023 (estimated)
Study completion: Dec 2023 (estimated)
First posted: 12 Aug 2016 (estimated)
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.

Studies objectives:

To evaluate the safety, tolerability and efficacy of ACC given in combination with ZA or with Denosumab as compared to placebo given with ZA or with Denosumab as outline below:

Safety and Tolerability:
Adverse events (AEs) and serious AEs
Safety laboratory measurements
Hypercalcemic and hypercalciuric episodes
Treatment withdrawal due to AEs and overall

Efficacy:

Skeletal Related Events (SREs)
Measurable and evaluable disease progression
Progression Free Survival (PFS)
Pain assessment via the VAS scale

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Amorphous calcium carbonate	Experimental	Drug: Amorphous calcium carbonateSubjects in this arm of the study will receive ACC tablets, containing 200 mg elemental calcium in addition to the standard treatment with ZA or Denosumab (4 mg once every 4 weeks for ZA and 120mg (1.7ml injection) every 4 weeks for Denosumab)
Placebo	Placebo comparator	Other: PlaceboSubjects in this arm of the study will receive Placebo tablets in addition to standard treatment with ZA or Denosumab (4 mg once every 4 weeks for ZA and 120mg (1.7ml injection) every 4 weeks for Denosumab)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Age > 18 year
Histologic proof of Castrate Resistant Prostate Cancer with Bone Metastasis
Systemic steroids are only allowed if needed for hormonal therapy
Previous radiation therapy must have been completed more than four weeks prior to enrollment into this study, unless subjects are under radiotherapy as a rescue therapy. Subjects must have recovered from all side effects.
The last dose of chemotherapy must have been completed at least four weeks prior to enrollment into this study, and subjects must have recovered from all side effects.

Key exclusion criteria (12 listed)

Concurrent treatment with acute anticancer therapy
Hormonal and corticosteroid therapies for Skeletal Related Events are not allowed
Sarcoidosis
Hypercalcemia
Hypophosphatemia

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 in this arm of the study will receive standard treatment with ZA or Denosumab (4 mg once every 4 weeks for ZA and 120mg (1.7ml injection) every 4 weeks for Denosumab) as well as AMOR-1 tablets, containing 200 mg elemental calcium per tablet, individually titrated up to the maximum level which does not induce grade 2 hypercalcemia.	Drug	Amorphous calcium carbonate
Placebomicrocrystalline cellulose	Other	Placebo

Primary outcome

Changes in the number of Skeletal Related Events (SREs)
Time frame: Bone scan will take place at baseline and week 12

10 secondary outcomes

Time from randomization to onset of first SRE.
Time frame: Bone scan will be made on baseline and week 12
Proportion of subjects (%) with SREs.
Time frame: Bone scan will take place at baseline and week 12
Proportion of subjects (%) with evidence of measureable and evaluable disease progression or SREs.
Time frame: Bone scan will take place at baseline and week 12
Progression Free Survival (PFS).
Time frame: CT or MRI will be assessed on screening and week 12
Number of subjects that are receiving radiation as a rescue treatment
Time frame: An assessment will take place at week 2,4,6,8,10,12 16,20 and 24
Frequency and incidence of treatment emergent adverse events (TEAEs)
Time frame: Safety assessment will take place at week 2,4,6,8,10,12 16,20 and 24
Frequency and incidence of serious treatment emergent adverse events (TEAEs).
Time frame: Safety assessment will take place at weeks 2,4,6,8,10,12 16,20 and 24
Proportion of subjects (%) with hypercalcemic DLTs.
Time frame: Safety assessment will be made at weeks 2,4,6,8,10,12 16,20 and 24
Proportion of subjects (%) with any DLTs.
Time frame: Safety assessment will take place at weeks 2,4,6,8,10,12 16,20 and 24
Number of hypercalciuric events.
Time frame: Urine calcium levels will be examined by urine tests, taking place at weeks 4,8,12,16,20 and 24

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
Individual participant dataSharing planned: No

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 in people with Castrate Resistant Prostate Cancer With Bone Metastasis, 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 15 inclusion and 12 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: withdrawn, 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. Some participants in this study may receive a placebo. 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 withdrawn before enrolling participants, so there are no results.

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?

Changes in the number of Skeletal Related Events (SREs) (time frame: Bone scan will take place at baseline and week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02864784.

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.