Ignite Creation Date:
2024-05-06 @ 1:11 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03952325
Status:
TERMINATED
Last Update Posted:
2021-07-30
First Post:
2019-05-14
Brief Title:
Tesetaxel Plus 3 Different PD-L1 Inhibitors in Patients With Triple-Negative MBC and Tesetaxel Monotherapy in Patients With HER2-Negative MBC
Sponsor:
Odonate Therapeutics Inc
Organization:
Odonate Therapeutics Inc
Study Overview
Official Title:
A Multicenter Phase 2 Study of Tesetaxel Plus Three Different PD-L1 Inhibitors in Patients With Triple-Negative Locally Advanced or Metastatic Breast Cancer and Tesetaxel Monotherapy in Elderly and Non-Elderly Adult Patients With HER2-Negative Locally Advanced or Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The Sponsor has discontinued the development of tesetaxel
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONTESSA TRIO
Brief Summary:
CONTESSA TRIO is a multi-cohort multicenter Phase 2 study of tesetaxel an investigational orally administered taxane in patients with metastatic breast cancer MBC In Cohort 1 approximately 200 patients with triple-negative MBC who have not received prior chemotherapy for advanced disease will be randomized 111 to receive tesetaxel plus either 1 nivolumab 2 pembrolizumab or 3 atezolizumab The primary efficacy endpoints for Cohort 1 are objective response rate ORR and progression free survival PFS in patients with programmed death-ligand 1 PD-L1 positive status In Cohort 2 approximately 60 elderly patients with human epidermal growth factor receptor 2 HER2 negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy The primary efficacy endpoints for Cohort 2 are ORR and PFS in patients with hormone receptor HR-positive HER2-negative disease In Cohort 3 approximately 60 non-elderly adult patients with HER2-negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy The primary efficacy endpoints for Cohort 3 are ORR and PFS in patients with HR positive HER2-negative disease
Detailed Description:
CONTESSA TRIO is a multi-cohort multicenter Phase 2 study of tesetaxel an investigational orally administered taxane in patients with MBC
Cohort 1
Approximately 200 patients with triple-negative MBC who have not received prior chemotherapy for advanced disease will be randomized 111 to receive tesetaxel dosed orally at 27 mgm2 once every three weeks Q3W plus either
Nivolumab at 360 mg by intravenous infusion Q3W
Pembrolizumab at 200 mg by intravenous infusion Q3W or
Atezolizumab at 1200 mg by intravenous infusion Q3W
Nivolumab and pembrolizumab programmed cell death protein 1 PD-1 inhibitors and atezolizumab a programmed death-ligand 1 PD-L1 inhibitor are immuno-oncology IO agents approved for the treatment of multiple types of cancer Two of these agents atezolizumab and pembrolizumab have been approved by the US Food and Drug Administration FDA as a first-line treatment for patients with triple-negative MBC The primary efficacy endpoints for Cohort 1 are ORR and PFS in patients with PD-L1 positive status The secondary efficacy endpoints are ORR and PFS in all patients duration of response DoR and overall survival OS
Cohort 2
Approximately 60 elderly patients with HER2-negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy dosed orally at 27 mgm2 Q3W The primary efficacy endpoints for Cohort 2 are ORR and PFS in patients with HR-positive HER2-negative disease The secondary efficacy endpoints are ORR and PFS in patients with triple-negative disease DoR and OS
Cohort 3
Approximately 60 non-elderly adult patients with HER2-negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy dosed orally at 27 mgm2 Q3W The primary efficacy endpoints for Cohort 3 are ORR and PFS in patients with HR positive HER2-negative disease The secondary efficacy endpoints are ORR and PFS in patients with triple negative disease DoR and OS
Cohort 1
Approximately 200 patients with triple-negative MBC who have not received prior chemotherapy for advanced disease will be randomized 111 to receive tesetaxel dosed orally at 27 mgm2 once every three weeks Q3W plus either
Nivolumab at 360 mg by intravenous infusion Q3W
Pembrolizumab at 200 mg by intravenous infusion Q3W or
Atezolizumab at 1200 mg by intravenous infusion Q3W
Nivolumab and pembrolizumab programmed cell death protein 1 PD-1 inhibitors and atezolizumab a programmed death-ligand 1 PD-L1 inhibitor are immuno-oncology IO agents approved for the treatment of multiple types of cancer Two of these agents atezolizumab and pembrolizumab have been approved by the US Food and Drug Administration FDA as a first-line treatment for patients with triple-negative MBC The primary efficacy endpoints for Cohort 1 are ORR and PFS in patients with PD-L1 positive status The secondary efficacy endpoints are ORR and PFS in all patients duration of response DoR and overall survival OS
Cohort 2
Approximately 60 elderly patients with HER2-negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy dosed orally at 27 mgm2 Q3W The primary efficacy endpoints for Cohort 2 are ORR and PFS in patients with HR-positive HER2-negative disease The secondary efficacy endpoints are ORR and PFS in patients with triple-negative disease DoR and OS
Cohort 3
Approximately 60 non-elderly adult patients with HER2-negative MBC who have not received prior chemotherapy for advanced disease will receive tesetaxel monotherapy dosed orally at 27 mgm2 Q3W The primary efficacy endpoints for Cohort 3 are ORR and PFS in patients with HR positive HER2-negative disease The secondary efficacy endpoints are ORR and PFS in patients with triple negative disease DoR and OS
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