Ignite Creation Date:
2024-05-06 @ 12:13 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03709446
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2018-10-14
Brief Title:
Leflunomide in Previously Treated Metastatic Triple Negative Cancers
Sponsor:
Joseph Sparano
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
A Phase III Trial of Leflunomide in Women With Previously Treated Metastatic Triple Negative Cancers
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Triple negative breast cancer TNBC represents about 15 of breast cancers and is characterized by the lack of expression of estrogen receptor ER progesterone receptor PR and HER-2 non-amplification Women with TNBC tend to be younger African American and BRCA-1 germline carriers The hallmark of this subtype is early metastatic recurrences with a peak frequency 1-2 years Prognosis for metastatic TNBC is especially poor with median survival of about 1 year as compared to about 2-4 years with other types of metastatic breast cancer
The primary objective of the phase I part of this study is to determine the safety tolerability and maximum tolerated dose of leflunomide in women with previously treated TNBC or ER HER2-neg MBC in Phase I The primary objective of the phase 2 part of this study is to determine the efficacy of leflunomide in patients with TNBC
Leflunomide which will be taken daily by mouth is an inhibitor of dihydroorotate dehydrogenase DHODH This proposal will test if DHODH is a novel target for a particular subset of women with metastatic TNBC
The primary objective of the phase I part of this study is to determine the safety tolerability and maximum tolerated dose of leflunomide in women with previously treated TNBC or ER HER2-neg MBC in Phase I The primary objective of the phase 2 part of this study is to determine the efficacy of leflunomide in patients with TNBC
Leflunomide which will be taken daily by mouth is an inhibitor of dihydroorotate dehydrogenase DHODH This proposal will test if DHODH is a novel target for a particular subset of women with metastatic TNBC
Detailed Description:
None
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