Open Label, Controlled, Post Marketing, Registry Study of Ribociclib (Ribo) Treatment Adherence and Patient Reported Outcomes in Participants Using ReX Technology Platform

NCT06344416 | Recruiting FDA Device

• 1 other identifier: RXG-001-2024-CLP (Rex-002)
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Any Solid Oral Medication

Keywords

Solid oral medication

Outcome Measures

Primary Outcomes (1)

• Outcome MeasureReX Platform Study Group

  Numerical variables will be tabulated using mean, standard deviation, minimum, median, maximum and number of observations. Categorical variables will be tabulated using number of observations and percentages. Two interim analyses are planned for this study: Interim analysis no. 1 will summarize 50 reviewed patient charts from the control group (completed as for January 2024) Interim analysis no. 2 will summarize about 25-30 participants from the ReX group, who used ReX for at least 1 month, and will compare them to control group (planned for April 2024).

  Up to 12 months

Study Arms (2)

Control Study Group

EXPERIMENTAL

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.

Device: Use of ReX to dispense and monitor solid oral medication therapy.

ReX Platform Study Group

EXPERIMENTAL

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.

Device: Use of ReX to dispense and monitor solid oral medication therapy.

Interventions

Use of ReX to dispense and monitor solid oral medication therapy. DEVICE

ReX Remote Digital Nurse comprising hand-held dispenser, disposable drug cartridge and web application (ReX Treatment Manager).

Control Study Group; ReX Platform Study Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male or female, at least 18 years of age.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participant has been routinely taking ribociclib for the past 60 days (without ReX platform).
• Participants prescribed ribociclib for off-label indications. Participants who failed to pass the learning module during the ReX training process.
• Participants who are at the end stage of their terminal illness with an anticipated life expectancy of 6 months or less.
• Participants who have a significant physical disability (including poor fine motor skills, impaired visual or auditory faculties, mental disorders, or another impairment), affecting ability to provide IRB research consent or use the ReX dispensing unit effectively.
• Participant is unsuited for participation in the study based on PI discretion

Sponsors & Collaborators

• Dosentrx Ltd.: lead

Study Sites (4)

Allina

Minneapolis, Minnesota, 55407, United States

RECRUITING

Texas Oncology

Austin, Texas, 78705, United States

RECRUITING

Virginia Cancer Center

Richmond, Virginia, 23229, United States

RECRUITING

Lumicera

Madison, Wisconsin, 53717, United States

RECRUITING

Related Links

• Website of ReX Remote Digital Nurse

Central Study Contacts

Mark Summers

CONTACT

+1 612 817 0959; msummers@dosentrx.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: A minimum of 50 and a maximum of 200 patient charts are expected to be reviewed for the control study group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study groups

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 3, 2024
• Study Start: March 30, 2024
• Primary Completion: March 30, 2025
• Study Completion: January 30, 2026
• Last Updated: March 12, 2025

Record last verified: 2024-08

Locations

US (4)