Ignite Creation Date:
2024-05-06 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03326674
Status:
TERMINATED
Last Update Posted:
2021-07-30
First Post:
2017-10-13
Brief Title:
Tesetaxel Plus Reduced Dose of Capecitabine vs Capecitabine in HER2 Negative HR Positive LAMBC
Sponsor:
Odonate Therapeutics Inc
Organization:
Odonate Therapeutics Inc
Study Overview
Official Title:
A Multinational Multicenter Randomized Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2 Negative HR Positive Locally Advanced or Metastatic Breast Cancer Previously Treated With 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
Brief Summary:
CONTESSA is a multinational multicenter randomized Phase 3 study of tesetaxel in patients with HER2 negative HR positive LAMBC previously treated with a taxane in the neoadjuvant or adjuvant setting The primary objective of the study is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on progression-free survival PFS as assessed by the Independent Radiologic Review Committee IRC 685 patients were enrolled
Detailed Description:
CONTESSA is a multinational multicenter randomized Phase 3 study of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone in patients with HER2 negative HR positive locally advanced or metastatic breast cancer LAMBC previously treated with a taxane in the neoadjuvant or adjuvant setting 685 patients were enrolled including 674 who received treatment
Patients randomly assigned to Arm A tesetaxel plus a reduced dose of capecitabine are administered
Tesetaxel 27 mgm2 orally once every 21 days on Day 1 of each 21-day cycle and
Capecitabine 825 mgm2 orally twice daily in the morning and evening after a meal for a total daily dose of 1650 mgm2 beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle
Patients randomly assigned to Arm B approved dose of capecitabine alone are administered
Capecitabine 1250 mgm2 orally twice daily in the morning and evening after a meal for a total daily dose of 2500 mgm2 beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle
Dose modifications for tesetaxel andor capecitabine are described in the study protocol
Patients are treated until documentation of progressive disease PD evidence of unacceptable toxicity or other decision to discontinue treatment Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in LAMBC The primary efficacy endpoint is PFS as assessed by the IRC The secondary efficacy endpoints are overall survival OS objective response rate ORR as assessed by the IRC and disease control rate DCR as assessed by the IRC
Patients randomly assigned to Arm A tesetaxel plus a reduced dose of capecitabine are administered
Tesetaxel 27 mgm2 orally once every 21 days on Day 1 of each 21-day cycle and
Capecitabine 825 mgm2 orally twice daily in the morning and evening after a meal for a total daily dose of 1650 mgm2 beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle
Patients randomly assigned to Arm B approved dose of capecitabine alone are administered
Capecitabine 1250 mgm2 orally twice daily in the morning and evening after a meal for a total daily dose of 2500 mgm2 beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle
Dose modifications for tesetaxel andor capecitabine are described in the study protocol
Patients are treated until documentation of progressive disease PD evidence of unacceptable toxicity or other decision to discontinue treatment Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in LAMBC The primary efficacy endpoint is PFS as assessed by the IRC The secondary efficacy endpoints are overall survival OS objective response rate ORR as assessed by the IRC and disease control rate DCR as assessed by the IRC
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