Ignite Creation Date:
2024-05-06 @ 2:09 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01983501
Status:
COMPLETED
Last Update Posted:
2020-09-21
First Post:
2013-10-28
Brief Title:
A Study of Tucatinib ONT-380 Combined With Ado-trastuzumab Emtansine T-DM1 in Patients With HER2 Breast Cancer
Sponsor:
Seagen Inc
Organization:
Seagen Inc
Study Overview
Official Title:
A Phase 1b Open-label Study to Assess the Safety and Tolerability of Tucatinib ONT-380 Combined With Ado-trastuzumab Emtansine Trastuzumab Emtansine T-DM1
Status:
COMPLETED
Status Verified Date:
2020-09
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:
The purpose of this study is to determine the maximal tolerated dose MTD or recommended dose RD and to assess the safety and tolerability of tucatinib ONT-380 combined with ado-trastuzumab emtansine T-DM1 in patients with HER2 breast cancer
Detailed Description:
This is a Phase 1b open-label study of tucatinib ONT-380 given in combination with ado-trastuzumab emtansine T-DM1 to patients with HER2 breast cancer
This study will use a 33 dose escalation design to evaluate up to four dose levels of tucatinib ONT-380 in order to identify the maximal tolerated doserecommended dose MTDRD of tucatinib ONT-380 in combination with T-DM1 T-DM1 will be administered intravenously on day 1 of each cycle except cycle 1 when it will be administered on day 2 to allow for PK assessments of tucatinib ONT-380 aloneTucatinib ONT-380 will be administered orally twice per day on days 1-21 of each cycle
There will be 3-6 evaluable patients enrolled in each cohort in the dose escalation phase unless that dose is found to be intolerable prior to completion of enrollment At least 6 evaluable patients are to be treated at a dose level in order for an MTDRD to be declared Once an MTDRD is declared an additional 24 evaluable patients will be in enrolled in a MTDRD expansion cohort for a total of 30 evaluable patients to be treated at the MTDRD
In addition to the MTDRD expansion cohort an optional additional cohort of up to 15 evaluable patients with either untreated asymptomatic CNS metastases not needing immediate local therapy or progressive CNS metastasis following local therapy may also be enrolled and treated at the MTDRD Up to 63 evaluable patients may be treated in this study
This study will use a 33 dose escalation design to evaluate up to four dose levels of tucatinib ONT-380 in order to identify the maximal tolerated doserecommended dose MTDRD of tucatinib ONT-380 in combination with T-DM1 T-DM1 will be administered intravenously on day 1 of each cycle except cycle 1 when it will be administered on day 2 to allow for PK assessments of tucatinib ONT-380 aloneTucatinib ONT-380 will be administered orally twice per day on days 1-21 of each cycle
There will be 3-6 evaluable patients enrolled in each cohort in the dose escalation phase unless that dose is found to be intolerable prior to completion of enrollment At least 6 evaluable patients are to be treated at a dose level in order for an MTDRD to be declared Once an MTDRD is declared an additional 24 evaluable patients will be in enrolled in a MTDRD expansion cohort for a total of 30 evaluable patients to be treated at the MTDRD
In addition to the MTDRD expansion cohort an optional additional cohort of up to 15 evaluable patients with either untreated asymptomatic CNS metastases not needing immediate local therapy or progressive CNS metastasis following local therapy may also be enrolled and treated at the MTDRD Up to 63 evaluable patients may be treated in this study
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