Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568692
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
A Phase 2 Study of PCS6422 with Capecitabine in Patients with Advanced or Metastatic Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Open-Label Study of PCS6422 with Capecitabine in Patients with Advanced or Metastatic Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an adaptive Phase 2 open-label randomized multi-center study evaluating up to 2 regimens of PCS6422 with capecitabine Cap vs standard dose of Cap alone in patients with advanced or metastatic breast cancer The goal of the study is to assess the efficacy and safety of PCS6422 Cap as a treatment option for patients with advanced or metastatic breast cancer who are not eligible for anthracycline- or taxane-containing therapies or other available therapies including PD-1 or PARP inhibitors
Detailed Description:
This is an adaptive Phase 2 open-label randomized multi-center study evaluating up to 2 regimens of PCS6422 with Cap vs standard dose of Cap alone in patients with advanced or metastatic breast cancer who are not eligible for anthracycline- or taxane-containing therapies or other available therapies including PD-1 or PARP inhibitors The goal of the study is to assess the efficacy and safety of PCS6422 Cap as a treatment option for patients with advanced or metastatic breast cancer who have been treated with chemotherapy in the metastatic setting
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