Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351332
Status:
SUSPENDED
Last Update Posted:
2024-06-20
First Post:
2024-04-02
Brief Title:
ZAP-IT ZN-c3 Carboplatin Pembrolizumab in MTNBC
Sponsor:
Filipa Lynce MD
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase III Single-arm Trial of Azenosertib ZN-c3 Combined with Carboplatin and Pembrolizumab in Patients with Metastatic Triple-negative Breast Cancer ZAP-IT
Status:
SUSPENDED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
IND clinical hold due to IND hold on a cross-referenced commercial IND
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This research is being done to evaluate the safety and effectiveness of a drug currently known as Azenosertib ZN-C3 in combination with the drugs carboplatin and pembrolizumab in metastatic triple-negative breast cancer
The names of the study drugs involved in this study are
Azenosertib a type of WEE1 inhibitor
Carboplatin a type of platinum compound
Pembrolizumab a type of monoclonal antibody
The names of the study drugs involved in this study are
Azenosertib a type of WEE1 inhibitor
Carboplatin a type of platinum compound
Pembrolizumab a type of monoclonal antibody
Detailed Description:
This is a non-randomized open-label phase III study designed to evaluate the safety and efficacy of azenosertib in combination with carboplatin and pembrolizumab in participants with metastatic triple negative breast cancer TNBC Azenosertib is a medication that targets WEE1 an important protein in tumor growth
The US Food and Drug Administration FDA has not approved azenosertib as a treatment for metastatic triple-negative breast cancer
The FDA has approved carboplatin as a treatment option for metastatic triple-negative breast cancer and it is considered standard of care for breast cancer
The FDA has approved pembrolizumab for metastatic triple-negative breast cancer but it is currently approved only for PD-L1 positive cancer
The research study procedures include screening for eligibility study treatment visits blood tests Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans electrocardiograms EKGs and tumor biopsies in Phase 2
It is expected that about 12-18 people will take part in the phase 1 portion and 60 people for the phase 2 portion of this research study
Zentalis Pharmaceuticals is funding this research study and providing Azenosertib Merck is supporting this research study by providing pembrolizumab
The US Food and Drug Administration FDA has not approved azenosertib as a treatment for metastatic triple-negative breast cancer
The FDA has approved carboplatin as a treatment option for metastatic triple-negative breast cancer and it is considered standard of care for breast cancer
The FDA has approved pembrolizumab for metastatic triple-negative breast cancer but it is currently approved only for PD-L1 positive cancer
The research study procedures include screening for eligibility study treatment visits blood tests Computerized Tomography CT scans Magnetic Resonance Imaging MRI scans electrocardiograms EKGs and tumor biopsies in Phase 2
It is expected that about 12-18 people will take part in the phase 1 portion and 60 people for the phase 2 portion of this research study
Zentalis Pharmaceuticals is funding this research study and providing Azenosertib Merck is supporting this research study by providing pembrolizumab
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