Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04862143
Status:
TERMINATED
Last Update Posted:
2024-06-20
First Post:
2021-04-21
Brief Title:
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
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
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-positiveHER2-negative Advanced Breast Cancer With a PIK3CA Mutation Treated With Alpelisib - Fulvestrant TELEPIK Trial
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study early terminated due to low enrollment compared to the anticipated figures
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TELEPIK
Brief 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
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-positiveHER2-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 andor 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 oncologists practice depending on the participants 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 investigators 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
The planned duration of treatment was 12 cycles of 28 days Participants could discontinue treatment earlier due to unacceptable toxicity disease progression andor 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 oncologists practice depending on the participants 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 investigators 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-005882-15 | EUDRACT_NUMBER | None | None |