Ignite Creation Date:
2024-05-06 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05041101
Status:
TERMINATED
Last Update Posted:
2024-06-10
First Post:
2021-09-02
Brief Title:
Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase IbII Study of Grapiprant IK-007 and Eribulin Combination Treatment for Metastatic Inflammatory Breast Cancer mIBC
Status:
TERMINATED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The sponsor terminated support for this study
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase IbII trial tests the safety and side effects of grapiprant and eribulin and whether they work to shrink tumors in patients with inflammatory breast cancer that has spread to other places in the body metastatic Grapiprant is an anti-inflammatory drug that may prevent tumor growth Eribulin may block tumor cell growth by stopping tumor cell division Giving grapiprant and eribulin together may help to control the disease
Detailed Description:
PRIMARY OBJECTIVE
I To determine the safety and efficacy of grapiprant and eribulin combination treatment for the patient with metastatic inflammatory breast cancer mIBC
SECONDARY OBJECTIVES
I To determine objective response rate ORR of the patients who achieve complete response CR or partial response PR
II To determine the time to progression TTP of the proposed treatment III To determine the duration of response of the proposed treatment Phase 2 only IV To determine the time to first response of the proposed treatment Phase 2 only V To determine progression-free survival PFS of the proposed treatment VI To determine the overall survival OS of the proposed treatment VII To investigate the predictive biomarker of the proposed treatment
EXPLORATORY OBJECTIVE
I To evaluate the changes in the tumor microenvironment after the proposed treatment
OUTLINE
Patients receive grapiprant orally PO twice daily BID on day 1-21 and eribulin mesylate intravenously IV over 5 minutes on days 1 and 8 Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days then yearly for up to 5 years
I To determine the safety and efficacy of grapiprant and eribulin combination treatment for the patient with metastatic inflammatory breast cancer mIBC
SECONDARY OBJECTIVES
I To determine objective response rate ORR of the patients who achieve complete response CR or partial response PR
II To determine the time to progression TTP of the proposed treatment III To determine the duration of response of the proposed treatment Phase 2 only IV To determine the time to first response of the proposed treatment Phase 2 only V To determine progression-free survival PFS of the proposed treatment VI To determine the overall survival OS of the proposed treatment VII To investigate the predictive biomarker of the proposed treatment
EXPLORATORY OBJECTIVE
I To evaluate the changes in the tumor microenvironment after the proposed treatment
OUTLINE
Patients receive grapiprant orally PO twice daily BID on day 1-21 and eribulin mesylate intravenously IV over 5 minutes on days 1 and 8 Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 30 days then yearly for up to 5 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 |
|---|---|---|---|
| 2021-0077 | OTHER | M D Anderson Cancer Center | None |
| NCI-2021-09158 | REGISTRY | None | None |