Any Solid Oral MedicationNCT06344416
Open Label, Controlled, Post Marketing, Registry Study of Ribociclib (Ribo) Treatment Adherence and Patient Reported Outcomes in Participants Using ReX Technology Platform
A study testing Use of ReX to dispense and monitor solid oral medication therapy. in people with Any Solid Oral Medication, run by Dosentrx Ltd. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Any Solid Oral Medication
- What is being tested?
- Use of ReX to dispense and monitor solid oral medication therapy.
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Mar 2024to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- -
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Texas Oncology
Austin, Texas, 78705
- Recruiting
Lumicera
Madison, Wisconsin, 53717
- Recruiting
Allina
Minneapolis, Minnesota, 55407
- Recruiting
Virginia Cancer Center
Richmond, Virginia, 23229
About this study
Official title: Study of Ribociclib (Ribo) Treatment Adherence Clinical Study Protocol
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.
Read the detailed 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:
- 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.
- ReX Remote Digital Nurse (ReX) is a portable medication dispenser with a touchscreen and communicates with the ReX Treatment Manager via the cellular network.
- ReX Treatment Manager (RTM) is a web application used for the collection and management of data collected by the ReX.
- Reminders dispatched to participants and caregivers according to a predefined logic: email, SMS or via support team call.
- Electronic Patient Reported Outcomes (ePROs) questions, tips, reminders, and groups of questions are presented to participants according to a defined logic and are collated in the ReX Treatment Manager.
- Thresholds in cases that participant reports exceed a predefined threshold notifications via email and/or text messages will be dispatched to the specified party.
- Conditions
- Any Solid Oral Medication
- Being tested
- Use of ReX to dispense and monitor solid oral medication therapy.
- Keywords
- Solid oral medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Use of ReX to dispense and monitor solid oral medication therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start30 Mar 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Any Solid Oral MedicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Study groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dosentrx Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06344416
- Sponsor's protocol ID
- RXG-001-2024-CLP (Rex-002)
- Status last verified
- Aug 2024
- First submitted
- 21 Mar 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Ribociclib (Ribo) Treatment Adherence Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT06344416
- Acronym / sponsor ID
- RXG-001-2024-CLP (Rex-002)
- Conditions
- Any Solid Oral Medication
- Keywords
- Solid oral medication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dosentrx Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- 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.
- ReX Remote Digital Nurse (ReX) is a portable medication dispenser with a touchscreen and communicates with the ReX Treatment Manager via the cellular network.
- ReX Treatment Manager (RTM) is a web application used for the collection and management of data collected by the ReX.
- Reminders dispatched to participants and caregivers according to a predefined logic: email, SMS or via support team call.
- Electronic Patient Reported Outcomes (ePROs) questions, tips, reminders, and groups of questions are presented to participants according to a defined logic and are collated in the ReX Treatment Manager.
- Thresholds in cases that participant reports exceed a predefined threshold notifications via email and/or text messages will be dispatched to the specified party.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Study groups
| Arm | Type | Receives |
|---|---|---|
| Control Study Group | Experimental | Device: Use of ReX to dispense and monitor solid oral medication therapy.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. |
| ReX Platform Study Group | Experimental | Device: Use of ReX to dispense and monitor solid oral medication therapy.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use 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). | Device | Control Study Group, ReX Platform Study Group |
Primary outcome
Outcome MeasureReX Platform Study Group
Time frame: Up to 12 months
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Website of ReX Remote Digital NurseLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of ReX to dispense and monitor solid oral medication therapy. in people with Any Solid Oral Medication, run by Dosentrx Ltd. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Summers (+1 612 817 0959, msummers@dosentrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome MeasureReX Platform Study Group (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.