Ignite Creation Date:
2024-05-06 @ 9:43 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03050398
Status:
TERMINATED
Last Update Posted:
2020-05-28
First Post:
2017-02-06
Brief Title:
A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK46 TherapyLEE011Ribociclib
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK46 TherapyLEE011Ribociclib
Status:
TERMINATED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
GCP issues
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was a companion study to CLEE011A2404 which provided the opportunity for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment
Detailed Description:
This was a multicenter non-treatment based companion sample collection protocol conducted in the US only This protocol sought to evaluate the aberrations of common pathways for newly diagnosed HRHER2- advanced breast cancer tumors and responses to ribociclib in diverse patient populations This companion sample collection protocol was available for all US patients enrolled on CLEE011A2404 CompLEEment-1 and did not alter the planned treatment Tumor collection required for this study occurred at two time points at baselinescreening and upon the development of progressive disease as shown in the protocol Patients eligible for this companion study were required to sign an optional additional consent form at the time of enrolling into the core trial
After eight patients had consented and samples had been taken it was determined that the companion study protocol had not been properly initiated or monitored at the sites This was determined to be a significant GCP violation and the clinical team made the decision to terminate the trial In addition to the GCP issues enrollment had been closed to the core study so enrolling additional patients was no longer possible The limited number of samples would not provide any meaningful analysis The samples were never analyzed The study was not terminated due to safety or efficacy concerns Samples collected were either destroyed or will be retained for up to 15 years based upon the decision of the patient
After eight patients had consented and samples had been taken it was determined that the companion study protocol had not been properly initiated or monitored at the sites This was determined to be a significant GCP violation and the clinical team made the decision to terminate the trial In addition to the GCP issues enrollment had been closed to the core study so enrolling additional patients was no longer possible The limited number of samples would not provide any meaningful analysis The samples were never analyzed The study was not terminated due to safety or efficacy concerns Samples collected were either destroyed or will be retained for up to 15 years based upon the decision of the patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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