NCT03582280: ONCO-004-1

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

Terminated Phase 1 Last updated 28 February 2024

What this trial tests

Phase 1 trial testing Amorphous Calcium Carbonate (ACC) - Amor in Oncology in 11 participants. Terminated before completion.

Timeline

18 July 2018

Primary endpoint
30 June 2022

31 October 2022

Quick facts

Lead sponsor	Amorphical Ltd.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	18 July 2018
Primary completion	30 June 2022
Estimated completion	31 October 2022
Sites	1 location across Israel

Drugs / interventions tested

• Amorphous Calcium Carbonate (ACC) - Amor — full drug profile →

Conditions studied

• Oncology — all drugs for Oncology →

Sponsor

Amorphical Ltd. — full company profile →

Who can join

Adults 18 to 119, any sex, with Oncology. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Amorphous Calcium Carbonate Shows Anti-Cancer Properties That are Attributed to Its Buffering Capacity.
   Natan Y, Blum YD, Arav A, Poliansky Y, et al · · 2023 · cited 2× · PMID 37568601 · DOI 10.3390/cancers15153785