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ReX Technology for Pill Adherence

N/A
Recruiting
Research Sponsored by Dosentrx Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights

Summary

This trial aims to see how many participants continue to use the ReX technology platform throughout the study and before stopping treatment. It also wants to compare the impact of the ReX platform on the duration and

Who is the study for?
This trial is for patients who are prescribed Ribociclib, a pill used to treat certain conditions. Participants must be willing to use the ReX technology platform, which helps dispense and monitor their medication therapy.
What is being tested?
The study is testing how well people stick with using the ReX technology platform over time and whether it affects how long they stay on Ribociclib treatment and how well they follow their dosing schedule compared to those not using ReX.
What are the potential side effects?
Since this trial focuses on adherence through a dispensing system (ReX), side effects would relate more to technical issues or user experience rather than medical symptoms typically associated with drug trials.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Outcome MeasureReX Platform Study Group

Trial Design

2Treatment groups
Experimental Treatment
Group I: ReX Platform Study GroupExperimental Treatment1 Intervention
The ReX platform study group will utilize data, collected from the same study sites that were chosen for control study group. A database consisting of at least fifty (50) female and male participants who initiated ribociclib for metastatic breast cancer and signed IRB research consent will be used for ReX study group. This group will include participants who started the recommended ribo dose of 600 mg QD and additional doses, delivered by the ReX technology platform. Physical examinations and laboratory tests will be performed in accordance with routine clinical practice; however, these parameters will not be collected for the study.
Group II: Control Study GroupExperimental Treatment1 Intervention
The control group of the study is designed to capture baseline data especially regarding ribo therapy duration of patients prescribed with ribociclib. Data will be collected by reviewing historical patient records as captured within the electronic medical record (chart review) by recording demographics, International Classification of Diseases (ICD-10) codes, prescription fill rates and Current Procedural Terminology (CPT) codes. De-identified data of patients treated with ribociclib for HR+/HER2 negative metastatic Breast Cancer (mBC) during June 2022 to April 2024 and collated in a de-identified database by Dosentrx will be retrospectively analyzed. The results of the treatment duration for these participants will be used as a baseline for the ReX study group. A minimum of 50 and a maximum of 200 patient charts are expected to be reviewed for the control study group.

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Who is running the clinical trial?

Dosentrx Ltd.Lead Sponsor
5 Previous Clinical Trials
1,200 Total Patients Enrolled
~100 spots leftby Mar 2025
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