Study of Ribociclib (Ribo) Treatment Adherence Clinical Study Protocol
Dosentrx Ltd.
Summary
Primary Objective: • To assess the persistence of ReX technology platform use, measured by the percentage (%) of participants who used ReX: 1) throughout the study period and 2) before the treatment discontinuation. Secondary Objective: • To evaluate the impact of the ReX technology platform on ribo treatment duration and ribo dose taking adherence as compared to control group.
Description
The ReX Platform is a class 1 FDA listed device under product code NXB Dispenser Solid Medication as a device that meets the exempt regulation 21 CFR 890.5050. and comprises the following components: 1. A disposable cartridge, a medication container supplied to participants pre-loaded with pills/capsules. The cartridge includes an integral mouthpiece, which dispenses the pill into the participant's mouth following application of an inhalation. 2. ReX Remote Digital Nurse (ReX) is a portable medication dispenser with a touchscreen and communicates with the ReX Treatment Manager via the cellula…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Male or female, at least 18 years of age. Diagnosis of HR+ HER2- metastatic breast cancer with ribociclib treatment that begun within last 60 days. Site has ability to dispense ribociclib in long term. Participant is able to read, understand and sign the IRB research consent for use of their data for research purposes. Participant is able and willing to complete Patient Reported Outcome (PRO) questionnaires during the study. Exclusion Criteria: • Participant has been routinely taking ribociclib for the past 60 days (without ReX platform). Participants prescribed riboc…
Interventions
- DeviceUse of ReX to dispense and monitor solid oral medication therapy.
ReX Remote Digital Nurse comprising hand-held dispenser, disposable drug cartridge and web application (ReX Treatment Manager).
Locations (4)
- AllinaMinneapolis, Minnesota
- Texas OncologyAustin, Texas
- Virginia Cancer CenterRichmond, Virginia
- LumiceraMadison, Wisconsin