Ignite Creation Date:
2024-05-06 @ 1:38 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01857193
Status:
COMPLETED
Last Update Posted:
2021-04-13
First Post:
2013-05-16
Brief Title:
Phase Ib Trial of LEE011 With Everolimus RAD001 and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase Ib Trial of LEE011 in Combination With Everolimus RAD001 and Exemestane in the Treatment of Postmenopausal Women With Hormone Receptor Positive HER2 Negative Locally Advanced or Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2021-04
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:
Dose Escalation part of the study To estimate the MTDs and or RP2D of LEE011 in combination with everolimus exemestane and LEE011 in combination with exemestane and to characterize the safety and tolerability of the combinations of everolimus exemestane LEE011 and LEE011 exemestane in patients with ER HER2- advanced breast cancer
Dose Expansion part of the study To characterize the safety and tolerability of the triplet combination of LEE011 everolimus exemestane in patients naïve or refractory to CDK46 inhibitor based therapy and the safety and tolerability of the doublet combination of LEE011 exemestane in patients refractory to CDK46 inhibitor based therapy except patients treated with prior LEE011 are not allowed in Group 3
Dose Expansion part of the study To characterize the safety and tolerability of the triplet combination of LEE011 everolimus exemestane in patients naïve or refractory to CDK46 inhibitor based therapy and the safety and tolerability of the doublet combination of LEE011 exemestane in patients refractory to CDK46 inhibitor based therapy except patients treated with prior LEE011 are not allowed in Group 3
Detailed Description:
The primary purpose of the phase Ib part of this study is to determine the maximum tolerated doses MTDs andor recommended phase II dose RP2D of LEE011 everolimus exemestane in patients with ER Her2- advanced breast cancer This part of the study will also assess safety tolerability and PK of the LEE011 exemestane LEE011 everolimus exemestane combinations
The Dose Expansion part of the study will evaluate the triple combination of LEE011 everolimus exemestane and the double combination of LEE011 exemestane for safety and tolerability
The Dose Expansion part of the study will evaluate the triple combination of LEE011 everolimus exemestane and the double combination of LEE011 exemestane for safety and tolerability
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