Ignite Creation Date:
2024-05-06 @ 12:06 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01495247
Status:
TERMINATED
Last Update Posted:
2020-12-08
First Post:
2011-09-30
Brief Title:
Phase IbII Trial of BEZ235 With Paclitaxel in Patients With HER2 Negative Locally Advanced or Metastatic Breast Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Dose-finding Phase Ib Study Followed by an Open-label Randomized Phase II Study of BEZ235 Plus Paclitaxel in Patients With HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2020-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study did not meet Phase Ib primary objective to establish the maximum tolerated doserecommended dose for Phase II
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective multi-center open-label phase Ib II study two parts with patients that have locally advanced or metastatic HER2 negative breast cancer The first part phase Ib will investigate the MTD Recommended Phase 2 Dose RP2D of the combination therapy of BEZ235 twice daily bid and weekly paclitaxel using a Bayesian model When MTD RP2D is established the second part phase II will start Phase II will evaluate the efficacy and the safety of weekly paclitaxel alone compared to weekly paclitaxel plus BEZ235 bid
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| 2011-002400-32 | EUDRACT_NUMBER | None | None |