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

NCT03582280 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-02-28

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Amorphical Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
119 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-18
Primary Completion
2022-06-30
Completion
2022-10-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03582280 on ClinicalTrials.gov