Ignite Creation Date:
2024-05-06 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05198843
Status:
TERMINATED
Last Update Posted:
2024-01-05
First Post:
2022-01-19
Brief Title:
Testing an Omega-3 Fatty Acid-Based Anti-Cancer Therapy for Patients With Triple-Negative Inflammatory Breast Cancer That Has Spread to Other Parts of the Body
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase IbII Study of EPA-Based EphA2 Targeted Therapy for Patients With Metastatic Triple-Negative Inflammatory Breast Cancer
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Other - Poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase IbII tests the safety side effects and best dose of icosapent ethyl in combination with dasatinib and whether they work to shrink tumors in patients with triple-negative inflammatory breast cancer that has spread to other places in the body metastatic Triple-negative inflammatory breast cancer is a type of inflammatory breast cancer in which the tumor cells do not have estrogen receptors progesterone receptors or large amounts of HER2neu protein on their surface Dasatinib is in a class of medications called tyrosine kinase inhibitors It works by blocking the action of an abnormal protein that signals cancer cells to multiply which may help keep cancer cells from growing Icosapent ethyl is an omega-3 fatty acid and in a class of medications called antilipemic or lipid-regulating agents It may decrease the amount of triglycerides and other fats made in the liver Preclinical studies have suggested that it may reduce the growth of triple negative inflammatory breast cancer cells Combination therapy with dasatinib and icosapent ethyl may help shrink tumors in patients with triple-negative inflammatory breast cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine maximum tolerated dose MTD of icosapent ethyl EPA and dasatinib in patients with metastatic triple negative inflammatory breast cancer mTN-IBC Phase 1b II To determine the overall response rate ORR of EPA and dasatinib therapy in patients with mTN-IBC Phase 2
SECONDARY OBJECTIVES
I To determine the clinical benefit rate CBR of EPA and dasatinib therapy in patients with mTN-IBC
II To determine progression-free survival PFS at 1 year for patients with mTN-IBC who were enrolled in the study and received EPA and dasatinib therapy
III To determine overall survival OS at 2 years for patients with mTN-IBC who were enrolled in the study and received EPA and dasatinib therapy
IV To determine the induction of apoptosis by EPA and dasatinib therapy
EXPLORATORY OBJECTIVES
I To determine the effect of EPA and dasatinib therapy on the expression of cholesterol transporter
II To determine the relationship between the expression of EphA2 and the treatment response to EPA and dasatinib therapy
III To determine the change in Ki67 by EPA and dasatinib therapy IV To evaluate the change in cholesterol homeostasis and tumor membrane rigidity after EPA and dasatinib therapy
V To investigate the effect of EPA and dasatinib therapy on the systemic inflammation
OUTLINE This is a phase Ib dose-escalation study of icosapent ethyl in combination with fixed dose dasatinib followed by a phase II study
Patients receive icosapent ethyl orally PO twice daily BID and dasatinib PO once daily QD in each treatment cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of the study treatment patients will undergo in-clinic post-treatment evaluations 1 month after their last study treatment or before starting new treatment whichever occurs first subsequently patients are followed every 3 months for 2 years
I To determine maximum tolerated dose MTD of icosapent ethyl EPA and dasatinib in patients with metastatic triple negative inflammatory breast cancer mTN-IBC Phase 1b II To determine the overall response rate ORR of EPA and dasatinib therapy in patients with mTN-IBC Phase 2
SECONDARY OBJECTIVES
I To determine the clinical benefit rate CBR of EPA and dasatinib therapy in patients with mTN-IBC
II To determine progression-free survival PFS at 1 year for patients with mTN-IBC who were enrolled in the study and received EPA and dasatinib therapy
III To determine overall survival OS at 2 years for patients with mTN-IBC who were enrolled in the study and received EPA and dasatinib therapy
IV To determine the induction of apoptosis by EPA and dasatinib therapy
EXPLORATORY OBJECTIVES
I To determine the effect of EPA and dasatinib therapy on the expression of cholesterol transporter
II To determine the relationship between the expression of EphA2 and the treatment response to EPA and dasatinib therapy
III To determine the change in Ki67 by EPA and dasatinib therapy IV To evaluate the change in cholesterol homeostasis and tumor membrane rigidity after EPA and dasatinib therapy
V To investigate the effect of EPA and dasatinib therapy on the systemic inflammation
OUTLINE This is a phase Ib dose-escalation study of icosapent ethyl in combination with fixed dose dasatinib followed by a phase II study
Patients receive icosapent ethyl orally PO twice daily BID and dasatinib PO once daily QD in each treatment cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of the study treatment patients will undergo in-clinic post-treatment evaluations 1 month after their last study treatment or before starting new treatment whichever occurs first subsequently patients are followed every 3 months for 2 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UM1CA186688 | NIH | CTEP | httpsreporternihgovquickSearchUM1CA186688 |
| NCI-2022-00004 | REGISTRY | None | None |
| 10480 | OTHER | None | None |
| 10480 | OTHER | None | None |