Advanced Breast CancerPhase 2TELEPIKNCT04862143
Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant
A Phase 2 study testing Alpelisib, Fulvestrant and Goserelin in people with Advanced Breast Cancer, run by Novartis Pharmaceuticals at 1 site in Sweden.
Trial summary
The study was designed to identify and register practical observations and experiences in connection with planning and implementing decentralized, patient-centered clinical trials at a geographic distance with virtual elements. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Alpelisib, Fulvestrant and Goserelin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteSweden
- Study dates
- 8 Mar 2022to 19 Sep 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is an adult ≥18 years old at the time of consent
- Participant with ABC (loco regionally recurrent or metastatic) not amenable to curative therapy.
- Participant with a histologically and/or cytologically confirmed diagnosis of ER-positive and/or PR-positive breast cancer by local laboratory.
- Participant with a confirmed HER2-negative ABC.
- Participant with a pathology report confirming PIK3CA mutant status by a certified laboratory using a validated PIK3CA mutation assay (from either tissue or blood).
- Participant was willing to operate a smartphone compatible with the software of the medical device and willing to manage applications
- Participant was willing to use the telemedicine platform and to follow the remote participant monitoring procedure.
Who cannot join
- Participant had received prior treatment with any PI3K, mTOR or AKT inhibitor.
- Participant with known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant.
- Participant participated in a prior investigational study within 30 days prior to the start of trial treatment or within 5 half-lives of the trial treatment, whichever was longer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Multicenter, Pilot-trial Evaluating the Safety and Utility of a Hybrid Decentralized Clinical Trial (DCT) Approach Using a TELEmedicine Platform in Patients With HR-positive/HER2-negative Advanced Breast Cancer With a PIK3CA Mutation Treated With Alpelisib - Fulvestrant TELEPIK Trial
The study was designed to identify and register practical observations and experiences in connection with planning and implementing decentralized, patient-centered clinical trials at a geographic distance with virtual elements.
Read the detailed description
The purpose of this open-label, single arm, multi-center, Phase II interventional pilot trial was to evaluate if a decentralized clinical trial (DCT) using a telemedicine platform offers a satisfactory, safe and suitable management for HR-positive/HER2-negative participants with advanced breast cancer harboring a PIK3CA mutation and treated with alpelisib plus fulvestrant. The trial utilized a hybrid DCT approach to reduce participant burden by bringing visits, services, and supplies closer to them.
The planned duration of treatment was 12 cycles of 28 days. Participants could discontinue treatment earlier due to unacceptable toxicity, disease progression and/or decision made at the discretion of the investigator or the participant.
On-site visits occurred during screening, at Cycle 1 Day 1 (baseline), and at end-of-trial. Visits at the local oncologist practice were planned on Day 1 of Cycle 2, Cycle 4, Cycle 7, and Cycle 10. Other visits were performed by a district nurse, either at home or at the local oncologist's practice, depending on the participant's preference.
During the on-site visit on Cycle 1, Day 1, participants were trained on using the telemedicine platform, and other monitoring devices used during remote participation: a glucometer and a smartphone with the telemedicine application installed. Study treatment was also initiated during this visit. The participants were then transitioned to remote participation enabled by the telemedicine platform with support of local healthcare providers (local oncologist, district nurse, or other qualified healthcare professional) under the investigator's oversight.
Discontinuation of remote participation was not a reason for trial termination. Participants who did not wish to continue with remote participation had the option to attend on-site visits.
The study planned to enroll approximately 20 participants, however the study was terminated prematurely with only 2 participants enrolled. The decision to terminate the study was due to delays during the start-up period and due to low enrollment. The decision to terminate was not related to any potential safety concern with alpelisib.
- Conditions
- Advanced Breast Cancer
- Being tested
- Alpelisib, Fulvestrant, Goserelin
- Keywords
- Decentralized clinical trial, advanced breast cancer, PIK3CA mutation, alpelisib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlpelisibDrug
Also called BYL719
Participants received a daily oral dose of 300 mg of alpelisib film-coated tablets for a total of 12 cycles, with each cycle lasting 28 days.
FulvestrantDrug
Participants were administered fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and on Day 1 of each 28-day cycle thereafter until Cycle 12.
GoserelinDrug
Pre-menopausal women were administered a dose of 3.6 mg of goserelin injection via intramuscular route, beginning on Cycle 1 Day 1. Subsequently, the same dose was administered on Day 1 of each 28-day cycle throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Alpelisib + fulvestrant | Experimental | Participants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle. Receives: Drug: Alpelisib; Drug: Fulvestrant; Drug: Goserelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Satisfaction Assessed Through the Trial Feedback Questionnaire (TFQ)
The TFQ was designed to capture the patient's experience during a clinical trial. The questionnaire consisted of 23 questions that assessed various aspects of the trial experience. Each question in the TFQ scored on a scale ranging from 1 (representing the worst response) to 5 (representing the best response). To calculate the total score, the scores obtained from each of the 23 questions were summed up. The resulting sum represented the participant's total score, which could ranged from 23 (indicating the lowest possible score) to 115 (indicating the highest possible score).
Measured: Baseline, and on Day 1 of Cycle 4 and 7. Cycle= 28 days
Secondary outcomes (12)
Patient Retention on the Decentralized Clinical Trial (DCT) Approach
Patient retention on the DCT approach was calculated as the percentage of participants on remote monitoring for participants still on treatment
Measured: At 3 and 6 months
Number of Unscheduled In-clinic Visits
Unscheduled in-clinic visits were defined as visits that were originally intended to be conducted remotely but were ultimately carried out on-site, or visits that were not originally scheduled but took place on-site or at the local oncologist's (regional hospital).
The total number of unscheduled in-clinic visits was evaluated
Measured: From the date of the first study treatment up to the end of study, assessed up to 6 months
Number of Unscheduled In-clinic Visits Because of Safety Reasons
Unscheduled in-clinic visits were defined as visits that were originally intended to be conducted remotely but were ultimately carried out on-site, or visits that were not originally scheduled but took place on-site or at the local oncologist's (regional hospital).
The total number of unscheduled in-clinic visits that were prompted by safety reasons was evaluated
Measured: From the date of the first study treatment up to the end of study, assessed up to 6 months
Number of Unscheduled In-clinic Visits Per Participant in the Study
Unscheduled in-clinic visits were defined as visits that were originally intended to be conducted remotely but were ultimately carried out on-site, or visits that were not originally scheduled but took place on-site or at the local oncologist's (regional hospital).
The total number of unscheduled in-clinic visits per participants was evaluated
Measured: From the date of the first study treatment up to the end of study, assessed up to 6 months
Number of Participants Who Discontinue Treatment Due to Adverse Events (AEs)
An AE refers to any untoward medical occurrence, such as an unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease.
The number of participants who discontinued the treatment due to adverse events was evaluated
Measured: From the date of the first study treatment up to the end of treatment, assessed up to 6 months
Number of Participants With Dose Reductions/Interruptions for Alpelisib
Number of participants with dose reductions and interruptions for alpelisib
Measured: From the date of the first study treatment up to the end of treatment, assessed up to 6 months
Number of Participants With Adverse Events of Special Interest (AESIs)- Hyperglycemia, Rash and Diarrhea
AESIs (Adverse Events of Special Interest) are defined as events, whether serious or non-serious, that are of scientific and medical concern specific to the sponsor's product or program. These events may require ongoing monitoring and communication by the investigator to the sponsor. For this study, the following AESIs were defined: hyperglycemia, rash, and diarrhea.
The number of participants experiencing these events per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 was evaluated.
Measured: From the date of the first study treatment up to the end of study, assessed up to 6 months
Number of Participants With Adverse Events (AEs) Leading to In-clinic Visits
An AE refers to any untoward medical occurrence, such as an unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease.
The number of participants with AEs per the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 leading to in-clinic visits was assessed.
Measured: From the date of the first study treatment up to the end of study, assessed up to 6 months
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
The EORTC QLQ-C30 questionnaire contained 30 items and was composed of both multi-item scales and single item measures. These included five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial impact), and a global health status/quality of life (QoL) scale.
All of the scales and single items ranged from 0 to 100. A high scale score represented a higher response level. Thus, a high score for a functional scale indicated a high/healthy level of functioning, a high score for the QoL indicated high QoL, but a high score for a symptom scale/single item indicated a high level of symptomatology/problems.
The EORTC QLQ-C30 scores for all functional and symptom scales were evaluated
Measured: Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 days
EuroQol 5-Dimension 5-Level (EQ-5D-5L)- Visual Analog Scale (VAS) Score
The 5-level EQ-5D (EQ-5D-5L) questionnaire is a standardized measure of health status. The EQ-5D descriptive system comprises of the 5 following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Along with the five dimensions of health, the EQ-5D-5L includes a VAS where respondents rate their overall health status on a scale from 0 to 100, where 0 represents the worst possible health state and 100 represents the best possible health state.
The EQ-5D-5L VAS scores were evaluated
Measured: Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 days
Brief Pain Inventory Short Form (BPI-SF) Scores
The BPI-SF was a questionnaire used to assess pain intensity and interference with daily activities. The Pain Severity Subscale included four questions asking individuals to rate their pain intensity on a scale from 0 to 10, with higher scores indicating more severe pain. The Pain Interference Subscale consisted of seven items that assessed how pain had interfered with activities, rated on the same scale. Both subscales had a total score range of 0 to 10, with higher scores indicating more significant pain or interference.
Measured: Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 days
Number of Participants With Progression-free Survival (PFS) According to RECIST 1.1
The number of participants with PFS was defined as the count of participants who did not experience disease progression or death due to any cause during the study. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 based on local radiology review.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start8 Mar 2022
- Primary completion19 Sep 2022
- Study completion19 Sep 2022
Why it stopped: Study early terminated due to low enrollment compared to the anticipated figures
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862143
- Sponsor's protocol ID
- CBYL719A03201
- Other IDs
- 2020-005882-15
- Acronym
- TELEPIK
- Status last verified
- Jun 2024
- First submitted
- 21 Apr 2021
- Last updated
- 20 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multicenter, Pilot-trial Evaluating the Safety and Utility of a Hybrid Decentralized Clinical Trial (DCT) Approach Using a TELEmedicine Platform in Patients With HR-positive/HER2-negative Advanced Breast Cancer With a PIK3CA Mutation Treated With Alpelisib - Fulvestrant TELEPIK Trial
- ClinicalTrials.gov ID
- NCT04862143
- Acronym / sponsor ID
- TELEPIK / CBYL719A03201
- Conditions
- Advanced Breast Cancer
- Keywords
- Decentralized clinical trial, advanced breast cancer, PIK3CA mutation, alpelisib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study early terminated due to low enrollment compared to the anticipated figures
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2022 (actual)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 19 Sep 2022 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Posted 20 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was designed to identify and register practical observations and experiences in connection with planning and implementing decentralized, patient-centered clinical trials at a geographic distance with virtual elements.
Detailed description
The purpose of this open-label, single arm, multi-center, Phase II interventional pilot trial was to evaluate if a decentralized clinical trial (DCT) using a telemedicine platform offers a satisfactory, safe and suitable management for HR-positive/HER2-negative participants with advanced breast cancer harboring a PIK3CA mutation and treated with alpelisib plus fulvestrant. The trial utilized a hybrid DCT approach to reduce participant burden by bringing visits, services, and supplies closer to them.
The planned duration of treatment was 12 cycles of 28 days. Participants could discontinue treatment earlier due to unacceptable toxicity, disease progression and/or decision made at the discretion of the investigator or the participant.
On-site visits occurred during screening, at Cycle 1 Day 1 (baseline), and at end-of-trial. Visits at the local oncologist practice were planned on Day 1 of Cycle 2, Cycle 4, Cycle 7, and Cycle 10. Other visits were performed by a district nurse, either at home or at the local oncologist's practice, depending on the participant's preference.
During the on-site visit on Cycle 1, Day 1, participants were trained on using the telemedicine platform, and other monitoring devices used during remote participation: a glucometer and a smartphone with the telemedicine application installed. Study treatment was also initiated during this visit. The participants were then transitioned to remote participation enabled by the telemedicine platform with support of local healthcare providers (local oncologist, district nurse, or other qualified healthcare professional) under the investigator's oversight.
Discontinuation of remote participation was not a reason for trial termination. Participants who did not wish to continue with remote participation had the option to attend on-site visits.
The study planned to enroll approximately 20 participants, however the study was terminated prematurely with only 2 participants enrolled. The decision to terminate the study was due to delays during the start-up period and due to low enrollment. The decision to terminate was not related to any potential safety concern with alpelisib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alpelisib + fulvestrant | Experimental | Drug: Alpelisib, Drug: Fulvestrant, Drug: GoserelinParticipants were administered alpelisib at a daily dose of 300 mg for 12 cycles of 28 days and fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and Day 1 of each subsequent cycle up to Cycle 12. Pre-menopausal women also received goserelin at a dose of 3.6 mg on Day 1 of each cycle. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant is an adult ≥18 years old at the time of consent
- Participant with ABC (loco regionally recurrent or metastatic) not amenable to curative therapy.
- Participant with a histologically and/or cytologically confirmed diagnosis of ER-positive and/or PR-positive breast cancer by local laboratory.
- Participant with a confirmed HER2-negative ABC.
- Participant with a pathology report confirming PIK3CA mutant status by a certified laboratory using a validated PIK3CA mutation assay (from either tissue or blood).
Key exclusion criteria (3 listed)
- Participant had received prior treatment with any PI3K, mTOR or AKT inhibitor.
- Participant with known hypersensitivity to alpelisib or fulvestrant, or to any of the excipients of alpelisib or fulvestrant.
- Participant participated in a prior investigational study within 30 days prior to the start of trial treatment or within 5 half-lives of the trial treatment, whichever was longer.
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 |
|---|---|---|
| AlpelisibAlso: BYL719Participants received a daily oral dose of 300 mg of alpelisib film-coated tablets for a total of 12 cycles, with each cycle lasting 28 days. | Drug | Alpelisib + fulvestrant |
| FulvestrantParticipants were administered fulvestrant at a dose of 500 mg via intramuscular injection on Cycle 1 Day 1 and Cycle 1 Day 15, and on Day 1 of each 28-day cycle thereafter until Cycle 12. | Drug | Alpelisib + fulvestrant |
| GoserelinPre-menopausal women were administered a dose of 3.6 mg of goserelin injection via intramuscular route, beginning on Cycle 1 Day 1. Subsequently, the same dose was administered on Day 1 of each 28-day cycle throughout the study. | Drug | Alpelisib + fulvestrant |
Primary outcome
Participant Satisfaction Assessed Through the Trial Feedback Questionnaire (TFQ)
Time frame: Baseline, and on Day 1 of Cycle 4 and 7. Cycle= 28 days
The TFQ was designed to capture the patient's experience during a clinical trial. The questionnaire consisted of 23 questions that assessed various aspects of the trial experience. Each question in the TFQ scored on a scale ranging from 1 (representing the worst response) to 5 (representing the best response). To calculate the total score, the scores obtained from each of the 23 questions were summed up. The resulting sum represented the participant's total score, which could ranged from 23 (indicating the lowest possible score) to 115 (indicating the highest possible score).
12 secondary outcomes
Patient Retention on the Decentralized Clinical Trial (DCT) Approach
Time frame: At 3 and 6 months
Number of Unscheduled In-clinic Visits
Time frame: From the date of the first study treatment up to the end of study, assessed up to 6 months
Number of Unscheduled In-clinic Visits Because of Safety Reasons
Time frame: From the date of the first study treatment up to the end of study, assessed up to 6 months
Number of Unscheduled In-clinic Visits Per Participant in the Study
Time frame: From the date of the first study treatment up to the end of study, assessed up to 6 months
Number of Participants Who Discontinue Treatment Due to Adverse Events (AEs)
Time frame: From the date of the first study treatment up to the end of treatment, assessed up to 6 months
Number of Participants With Dose Reductions/Interruptions for Alpelisib
Time frame: From the date of the first study treatment up to the end of treatment, assessed up to 6 months
Number of Participants With Adverse Events of Special Interest (AESIs)- Hyperglycemia, Rash and Diarrhea
Time frame: From the date of the first study treatment up to the end of study, assessed up to 6 months
Number of Participants With Adverse Events (AEs) Leading to In-clinic Visits
Time frame: From the date of the first study treatment up to the end of study, assessed up to 6 months
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 days
EuroQol 5-Dimension 5-Level (EQ-5D-5L)- Visual Analog Scale (VAS) Score
Time frame: Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 days
Brief Pain Inventory Short Form (BPI-SF) Scores
Time frame: Baseline, and on Day 1 of Cycle 4, and 7 and end of treatment, assessed up to 6 months. Cycle= 28 days
Number of Participants With Progression-free Survival (PFS) According to RECIST 1.1
Time frame: Up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Patient Lay Trial SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alpelisib, Fulvestrant and Goserelin in people with Advanced Breast Cancer, run by Novartis Pharmaceuticals at 1 site in Sweden.
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 7 inclusion and 3 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: stopped early, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Satisfaction Assessed Through the Trial Feedback Questionnaire (TFQ) (time frame: Baseline, and on Day 1 of Cycle 4 and 7. Cycle= 28 days). 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 20 Jun 2024.