Ignite Creation Date:
2024-05-06 @ 2:37 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02088684
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2014-03-12
Brief Title:
Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase IbII Study of LEE011 in Combination With Fulvestrant and BYL719 or BKM120 in the Treatment of Postmenopausal Women With Hormone Receptor Positive HER2 Negative Locally Recurrent or Advanced Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to explore the clinical utility of the three investigational agents in HR HER2- breast cancer LEE011 CDK46 inhibitor BKM120 PI3K-pan class I-inhibitor and BYL719 PI3K-alpha specific class I inhibitor in combination with fulvestrant
This is a multi-center open-label Phase IbII study The Phase Ib portion of the study is a dose escalation to estimate the MTD andor RP2D for three regimens LEE011 with fulvestrant LEE011 and BKM120 with fulvestrant LEE011and BYL719 with fulvestrant
The Phase II portion of the study was planned to be a randomized study to assess the anti-tumor activity as well as safety and tolerability of LEE011 with fulvestrant to LEE011 and BKM120 with fulvestrant and LEE011 and BYL719 with fulvestrant in patients with ERHER2- locally advanced or metastatic breast cancer
Approximately 216 adult women with ERHER2- locally advanced or metastatic breast cancer were planned to be enrolled
This is a multi-center open-label Phase IbII study The Phase Ib portion of the study is a dose escalation to estimate the MTD andor RP2D for three regimens LEE011 with fulvestrant LEE011 and BKM120 with fulvestrant LEE011and BYL719 with fulvestrant
The Phase II portion of the study was planned to be a randomized study to assess the anti-tumor activity as well as safety and tolerability of LEE011 with fulvestrant to LEE011 and BKM120 with fulvestrant and LEE011 and BYL719 with fulvestrant in patients with ERHER2- locally advanced or metastatic breast cancer
Approximately 216 adult women with ERHER2- locally advanced or metastatic breast cancer were planned to be enrolled
Detailed Description:
On 31-May-2016 Novartiss made the decision decision to not open the Phase II portion of the study for business reasons Sufficient data had already been collected and no additional data for the triplet combinations was needed As a result the Phase II portion of the trial was not opened
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