Overview

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

Status:
Unknown status

Trial end date:
2019-06-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 1

Details

Lead Sponsor:

Amorphical Ltd.

Treatments:

Calcium
Calcium Carbonate
Calcium, Dietary