NCT03582280

The Effect of Amorphous Calcium Carbonate (ACC) Treatment on Function and Welfare in Late-stage Solid Cancer Subjects

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Amorphical Ltd. · Industry
• Sex: All
• Age: 18 Years – 119 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Oncology

Interventions

Type	Name	Description
DRUG	Amorphous Calcium Carbonate (ACC) - Amor	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

Timeline

• Start date: 2018-07-18
• Primary completion: 2022-06-30
• Completion: 2022-10-31
• First posted: 2018-07-10
• Last updated: 2024-02-28

Locations

1 site across 1 country: Israel