To Study the Effect of Amorphous Calcium Carbonate (ACC) Treatment on Function and Welfare Improvement in Late-stage Solid Cancer Subjects
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|ClinicalTrials.gov Identifier: NCT03582280|
Recruitment Status : Unknown
Verified April 2019 by Amorphical Ltd..
Recruitment status was: Recruiting
First Posted : July 10, 2018
Last Update Posted : April 2, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Oncology||Drug: Amorphous Calcium Carbonate (ACC) - Amor||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Exploratory, Open Label Study to Improve the Function and Welfare of Late-stage Solid Cancer Subjects (With or Without Lung Involvement) by Amorphous Calcium Carbonate (ACC) Treatment, Administered Orally and Concomitantly With Inhalation|
|Actual Study Start Date :||July 18, 2018|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: Amorous Calcium Carbonate (ACC) - Amor
The investigational product will include:
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
- Visual Analogue Scale (VAS) score for pain [ Time Frame: week 0, week 1, week 2, week 3, week 6, week 12, week 18, week 24 ]Assessing a change in Pain VAS score The scale is between 0-10. 0 is a score for no pain 5 is a score for moderate pain 10 is a score for unbearable pain
- ECOG Performance status (PS) [ Time Frame: week 0, week 1, week 2, week 3, week 6, week 12, week 18, week 24 ]Assessing a change in PS Grade 0 - Fully active, able to carry on all pre-disease performance without restriction Grade1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work Grade 2 - Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours Grade 3 - Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours Grade 4 - Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair Grade 5 - Dead
- Oxygen saturation [ Time Frame: week 0, week 1, week 2, week 3, week 6, week 12, week 18, week 24 ]Assessing a change in oxygen saturation Normal pulse oximeter readings usually range from 95 to 100 percent. Values under 90 percent are considered low.
- Progression Free Survival [ Time Frame: week 0, week 12, week 24 ]Assessing a change from baseline in tumor's growth and size by using CT
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): NCT03582280
|Contact: Julia Rothman, Dr.||firstname.lastname@example.org|
|Hadassah Ein Carem||Recruiting|
|Contact: Hovav Nechustan, prof. 972-(0)2-6776911|
|Principal Investigator: Hovav Nechustan, MD|