ReX Technology for Pill Adherence

Recruiting at 5 trial locations

Overseen By Mark Summers

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dosentrx Ltd.

Must be taking: Ribociclib

Disqualifiers: End stage illness, Physical disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 12 months

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on participants who are starting ribociclib treatment, so you may need to continue with ribociclib if you are already on it.

What data supports the effectiveness of the ReX Technology Platform for improving medication adherence?

The ReX Technology Platform is designed to improve medication adherence by tracking pills from packaging to ingestion, providing real-time adherence data, and enabling patient engagement through reporting and messaging. This system addresses common issues with traditional adherence methods, which often miss actual pill intake and suffer from patient bias. ^{1 2 3 4 5}

Is ReX Technology (Ribociclib) safe for humans?

Ribociclib, also known as ReX Technology, has been shown to be generally safe in humans, with common side effects including low white blood cell counts, nausea, fatigue, and diarrhea. No serious adverse events were observed in studies with healthy participants. ^{6 7 8 9 10}

How does the ReX Technology treatment differ from other treatments for pill adherence?

ReX Technology is unique because it uses a digital system to track and manage medication adherence in real-time, from packaging to ingestion, unlike traditional methods that are periodic and prone to errors. It includes a reusable dispenser, a disposable pill cassette, and a cloud-based portal for data, making it more comprehensive and interactive than other adherence solutions. ^{1 11 12 13 14}

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

My treatment center can provide long-term access to ribociclib.

I am willing and able to fill out questionnaires about my health during the study.

I started treatment with ribociclib for my HR+ HER2- metastatic breast cancer within the last 60 days.

Exclusion Criteria

Participants who are at the end stage of their terminal illness with an anticipated life expectancy of 6 months or less

I have been taking ribociclib regularly for the last 60 days.

I am taking ribociclib for a condition not listed on the label.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the ReX technology platform to manage ribociclib treatment adherence and report outcomes

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ReX Technology Platform

Trial Overview 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.

Participant Groups

Group I: ReX Platform Study Group Experimental Treatment 1 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 Group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Dosentrx Ltd.

Lead Sponsor

Trials

6

Recruited

1,400+

Findings from Research

The ReX medication management system significantly improved adherence rates, achieving 97.6% adherence compared to 76.3% with standard packaging, demonstrating its efficacy in enhancing medication compliance.

The ReX system was well-accepted and easy to use, with 87% of subjects finding it user-friendly and no adverse events reported during the studies, indicating its safety for patient use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Digital Medication Management System for Effective Assessment and Enhancement of Patient Adherence to Therapy (ReX): Feasibility Study. Shtrichman, R., Conrad, S., Schimo, K., et al.[2020]

Accurate measurement of medication adherence is crucial for effective patient care and evaluating treatment options, with electronic methods now being the standard for tracking dosing history.

Inadequate adherence is often underestimated, leading to unrecognized treatment failures and potential toxicity from missed doses, highlighting the need for standardized terminology and methods in adherence assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to medications: insights arising from studies on the unreliable link between prescribed and actual drug dosing histories. Blaschke, TF., Osterberg, L., Vrijens, B., et al.[2022]

In a study of 79 patients taking metformin, those with less than 80% adherence who received cue-dose training showed a significant improvement in medication adherence by 15% over 4 months.

While cue-dose training improved adherence to metformin, it did not significantly affect adherence to other antihyperglycemic medications, and there was no difference in blood sugar control between the groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic monitoring and counseling to improve medication adherence. Rosen, MI., Rigsby, MO., Salahi, JT., et al.[2013]

A study of breast cancer patients showed that those using mail order pharmacies had higher adherence to their endocrine therapy, especially when copayments were low and 90-day prescriptions were available.

For patients using local pharmacies, adherence was better when they used a single pharmacy and had synchronized medication refills, highlighting the importance of medication delivery methods and costs in treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication delivery factors and adjuvant endocrine therapy adherence in breast cancer. Neuner, JM., Fergestrom, N., Pezzin, LE., et al.[2023]

In a study of 693 young women with hormone receptor-positive breast cancer, 9% did not start oral adjuvant endocrine therapy (ET) within 18 months, with Black women showing higher odds of non-initiation.

Among those who started ET, 20% were non-persistent, with factors like younger age and marital status influencing adherence; however, non-persistence was linked to lower recurrence rates, suggesting that decision-making support could enhance adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant endocrine therapy non-initiation and non-persistence in young women with early-stage breast cancer. Rosenberg, SM., Zheng, Y., Gelber, S., et al.[2023]

Ribociclib, a CDK 4/6 inhibitor, significantly improves median progression-free survival (PFS) in women with HR+/HER2- metastatic breast cancer when used in combination with endocrine therapy, with PFS ranging from 8 to 13 months across three phase III trials.

The treatment is well tolerated, particularly in elderly patients, and while it has some dose-limiting toxicities like neutropenia and QTc prolongation, it maintains health-related quality of life and reduces pain scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ribociclib in HR+/HER2- Advanced or Metastatic Breast Cancer Patients. Rascon, K., Flajc, G., De Angelis, C., et al.[2020]

Ribociclib, a CDK4/6 inhibitor, has shown safety and efficacy when used with endocrine therapy for advanced breast cancer, with a bioavailability of 65.8% for the oral 600-mg tablet.

The study confirmed that the oral tablet and capsule formulations of ribociclib are bioequivalent, with no serious adverse events reported, indicating a reliable and safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Absolute Oral Bioavailability and Bioequivalence of Ribociclib, a Cyclin-Dependent Kinase 4/6 Inhibitor, in Healthy Subjects. Ji, Y., Abdelhady, AM., Samant, TS., et al.[2021]

Ribociclib, approved by the FDA for treating advanced breast cancer, significantly improves progression-free survival when combined with letrozole compared to a placebo, as shown in a study of 668 patients.

The overall response rate for patients receiving ribociclib plus letrozole was 52.7%, compared to 37.1% for those on placebo, indicating its efficacy, although common side effects included neutropenia and nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer. Shah, A., Bloomquist, E., Tang, S., et al.[2019]

Ribociclib is an oral medication that inhibits CDK 4 and 6, leading to cell cycle arrest in cancer cells, and has been approved in the USA for treating advanced breast cancer in combination with an aromatase inhibitor.

The drug is currently undergoing further phase III trials for breast cancer and is being tested in early-phase trials for other types of solid tumors and blood cancers, highlighting its potential as a versatile cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ribociclib: First Global Approval. Syed, YY.[2018]

In a study of 554 Italian patients with hormone receptor-positive, HER2-negative advanced breast cancer, ribociclib combined with letrozole showed a clinical benefit rate of 71.7% and a median time to progression of 26.7 months, indicating effective treatment outcomes.

The treatment was associated with manageable safety profiles, with 98.9% of patients experiencing all-grade adverse events, primarily neutropenia, but health-related quality of life scores remained stable during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ribociclib in Combination with Letrozole in Patients with HR+, HER2- Advanced Breast Cancer: Results from the Italian Subpopulation of Phase 3b CompLEEment-1 Study. De Laurentiis, M., Caputo, R., Mazza, M., et al.[2022]

A new method called co-encapsulation (CoE) combines oral medications with an edible ingestion sensor (IS) to create 'digitized' medications that accurately track when patients take their medicine, enhancing medication adherence.

In a study involving 12 patients with active tuberculosis, the CoE-IS-Rifamate showed bioequivalence to the standard Rifamate formulation, meaning it works just as effectively without compromising the quality of the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digitizing Medicines for Remote Capture of Oral Medication Adherence Using Co-encapsulation. Browne, SH., Peloquin, C., Santillo, F., et al.[2019]

Poor medication adherence affects about 50% of patients with chronic diseases, leading to variability in drug effectiveness and safety, which is a significant challenge for precision medicine.

A new cross-technology platform using edible ingestion sensors can accurately measure medication adherence by linking pharmacokinetic models with real-time data on drug ingestion, potentially improving drug development and clinical trial outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A New Approach to Measure Adherence to Medicines Using Biomarkers and Sensors. Özdemir, V., Endrenyi, L.[2020]

Adherence to prescribed drug dosages is crucial for accurately estimating the dose-response relationship in clinical studies, as non-compliance can introduce variability that complicates results.

A networked system with an ingestible sensor demonstrated a high detection accuracy of 99.3% for confirming drug ingestion, allowing for better assessment of actual dosing patterns and their impact on drug efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role for direct electronic verification of pharmaceutical ingestion in pharmaceutical development. DiCarlo, LA.[2012]

The Ingestible Sensor System (ISS) demonstrated 100% accuracy in detecting the ingestion of oral medications in a study of 20 kidney transplant patients over an average of 9.2 weeks, indicating its potential for improving treatment adherence.

While the ISS showed high adherence rates (99.4%) and no serious adverse events, some patients experienced gastrointestinal symptoms and skin irritation from the monitoring device, highlighting the need for careful patient management during use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication adherence assessment: high accuracy of the new Ingestible Sensor System in kidney transplants. Eisenberger, U., Wüthrich, RP., Bock, A., et al.[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Use of a Digital Medication Management System for Effective Assessment and Enhancement of Patient Adherence to Therapy (ReX): Feasibility Study. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Adherence to medications: insights arising from studies on the unreliable link between prescribed and actual drug dosing histories. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Electronic monitoring and counseling to improve medication adherence. [2013]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Medication delivery factors and adjuvant endocrine therapy adherence in breast cancer. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Adjuvant endocrine therapy non-initiation and non-persistence in young women with early-stage breast cancer. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Ribociclib in HR+/HER2- Advanced or Metastatic Breast Cancer Patients. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Absolute Oral Bioavailability and Bioequivalence of Ribociclib, a Cyclin-Dependent Kinase 4/6 Inhibitor, in Healthy Subjects. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

FDA Approval: Ribociclib for the Treatment of Postmenopausal Women with Hormone Receptor-Positive, HER2-Negative Advanced or Metastatic Breast Cancer. [2019]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Ribociclib: First Global Approval. [2018]

10. France pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ribociclib in Combination with Letrozole in Patients with HR+, HER2- Advanced Breast Cancer: Results from the Italian Subpopulation of Phase 3b CompLEEment-1 Study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Digitizing Medicines for Remote Capture of Oral Medication Adherence Using Co-encapsulation. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

A New Approach to Measure Adherence to Medicines Using Biomarkers and Sensors. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Role for direct electronic verification of pharmaceutical ingestion in pharmaceutical development. [2012]

14. United States pubmed.ncbi.nlm.nih.gov

Medication adherence assessment: high accuracy of the new Ingestible Sensor System in kidney transplants. [2022]