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

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ClinicalTrials.gov Identifier: NCT02864784
Recruitment Status : Unknown
Verified August 2016 by Amorphical Ltd..
Recruitment status was:  Not yet recruiting
First Posted : August 12, 2016
Last Update Posted : August 12, 2016
Sponsor:
Information provided by (Responsible Party):
Amorphical Ltd.

Brief Summary:

Studies objectives:

To evaluate the safety, tolerability and efficacy of AMOR-1 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

Condition or disease Intervention/treatment Phase
Castrate Resistant Prostate Cancer With Bone Metastasis Drug: Amorphous calcium carbonate Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Experimental: Amorphous calcium carbonate
Subjects in this arm of the study will receive AMOR-1 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)
Drug: Amorphous calcium carbonate
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.
Other Name: AMOR-1

Placebo Comparator: Placebo
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)
Other: Placebo



Primary Outcome Measures :
  1. Changes in the number of Skeletal Related Events (SREs) [ Time Frame: Bone scan will take place at baseline and week 12 ]

Secondary Outcome Measures :
  1. Time from randomization to onset of first SRE. [ Time Frame: Bone scan will be made on baseline and week 12 ]
  2. Proportion of subjects (%) with SREs. [ Time Frame: Bone scan will take place at baseline and week 12 ]
  3. 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 ]
  4. Progression Free Survival (PFS). [ Time Frame: CT or MRI will be assessed on screening and week 12 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 year
  2. Histologic proof of Castrate Resistant Prostate Cancer with Bone Metastasis
  3. Systemic steroids are only allowed if needed for hormonal therapy
  4. 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.
  5. 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.
  6. Subjects must have a performance status of 0-2 by the ECOG Scale.
  7. 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).
  8. Subjects must be normo-calcemic upon study entry.
  9. 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.
  10. 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.
  11. Estimated life expectancy of > 3 months.
  12. Subjects must be accessible for follow-up.
  13. Written informed consent will be obtained.

Exclusion Criteria:

  1. Concurrent treatment with acute anticancer therapy
  2. Hormonal and corticosteroid therapies for Skeletal Related Events are not allowed
  3. Sarcoidosis
  4. Hypercalcemia
  5. Hypophosphatemia
  6. Hypoparathyroidism/Hyperparathyroidism
  7. Major surgery within 4 weeks of anticipated inception of AMOR-1therapy
  8. Serious intercurrent infections or non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of therapy
  9. Psychiatric disorders rendering subjects incapable of complying with the requirements of the protocol
  10. Any illness or condition deemed by the investigator to contra-indicate treatment with AMOR-1 or ZA or Denosumab
  11. 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.
  12. Active cancer treatment except hormonal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864784


Contacts
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Contact: Galia Goldfeld, MD +972-(0)54-6871317 galia@amorphical.com

Locations
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Israel
Soroka Medical Center
Beer sheva, Israel, 84101
Sponsors and Collaborators
Amorphical Ltd.
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Responsible Party: Amorphical Ltd.
ClinicalTrials.gov Identifier: NCT02864784    
Other Study ID Numbers: AMCS-ONCO-PR-001-CTIL
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: August 12, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Neoplastic Processes
Pathologic Processes
Calcium Carbonate
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents