This phase Ib/II 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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Given IV
Given PO
M D Anderson Cancer Center
Houston, Texas, United States
Determine the Safety of Grapiprant and Eribulin Combination Treatment
Dose-limiting toxicity was defined as probable, possible, and definite events that occurred in the first 21 days (Cycle 1), as prespecified in the protocol.
Time frame: Up to 21 days from the initial treatment
Determine the Efficacy of Grapiprant and Eribulin Combination Treatment
Clinical Benefit Rate (CBR) was defined as the ratio of patients who achieved a complete response (CR), partial response (PR), or stable disease (SD) (lasting \>24 weeks).
Time frame: Up to 1 year
Determine Objective Response Rate (ORR)
The percentage of the patients who achieved complete response (CR) or partial response (PR).
Time frame: Up to 1 year
Determine the Time to Progression (TTP) of the Proposed Treatment.
Time to progression (TTP), defined as the time from the start of grapiprant treatment to objective tumor progression (PD), was analyzed using the Kaplan-Meier method, and the median with 95% confidence intervals was reported.
Time frame: Up to 1 year
Determine the Duration of Response of the Proposed Treatment in Phase II
The time from observing the response to the grapiprant treatment until objective tumor progression (PD)
Time frame: Up to 2 years
Determine the Time to First Response of the Proposed Treatment in Phase II
The time from starting grapiprant treatment until observing the response.
Time frame: Up to 2 years
Determine Progression-free Survival (PFS) of the Proposed Treatment
Progression-free survival (PFS) was defined as the time from starting grapiprant treatment until objective tumor progression (PD) or death from any cause and was summarized using the Kaplan-Meier method, including the median with 95% confidence intervals.
Time frame: Up to 1 year
Determine the Overall Survival (OS) of the Proposed Treatment
Overall survival (OS) was defined as the time from starting grapiprant treatment until death from any cause and was summarized using the Kaplan-Meier method, including the median with 95% confidence intervals.
Time frame: Up to 1.5 year
Investigate the Predictive Biomarker for the Proposed Treatment
Determine the association between treatment response and the change in prostaglandin E2 metabolite (PGEM) levels in urine samples collected pre- and post-treatment.
Time frame: Baseline and Cycle 2
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