Ignite Creation Date:
2024-05-06 @ 12:49 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03858972
Status:
TERMINATED
Last Update Posted:
2021-07-30
First Post:
2019-02-26
Brief Title:
Tesetaxel Plus Reduced Dose of Capecitabine in Patients With HER2 Negative HR Positive LAMBC
Sponsor:
Odonate Therapeutics Inc
Organization:
Odonate Therapeutics Inc
Study Overview
Official Title:
Multinational Multicenter Phase 2 Study of Tesetaxel Plus a Reduced Dose of Capecitabine in Patients With HER2 Negative Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane
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 2
Brief Summary:
CONTESSA 2 is a multinational multicenter Phase 2 study of tesetaxel in patients with HER2 negative HR positive locally advanced or metastatic breast cancer LAMBC not previously treated with a taxane The primary objective of the study is to establish the efficacy of tesetaxel plus a reduced dose of capecitabine based on objective response rate ORR as assessed by an Independent Radiologic Review Committee IRC 152 patients were enrolled
Detailed Description:
CONTESSA 2 is a multinational multicenter Phase 2 study of tesetaxel an investigational orally administered taxane in patients with HER2 negative HR Positive LAMBC not previously treated with a taxane in the neoadjuvant adjuvant or metastatic setting This Study complements CONTESSA a multinational multicenter randomized Phase 3 study in patients with HER2 negative HR positive LAMBC previously treated with a taxane in the neoadjuvant or adjuvant setting 152 patients were enrolled including 149 who received treatment Patients are administered tesetaxel at 27 mgm2 orally once every 21 days on the first day of each 21-day cycle plus capecitabine at 825 mgm2 orally twice daily for a total daily dose of 1650 mgm2 for 14 days of each 21-day cycle Patients in the dense pharmacokinetics PK cohort receive a single dose of capecitabine monotherapy prior to starting the combination regimen Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in LAMBC The primary efficacy endpoint is ORR as assessed by the IRC The secondary efficacy endpoints are duration of response DoR as assessed by the IRC progression-free survival PFS as assessed by the IRC disease control rate DCR as assessed by the IRC and overall survival OS CONTESSA 2 also investigates the PK of tesetaxel
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