NCT05041101

Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer

Phase Ib/II Study of Grapiprant (IK-007) and Eribulin Combination Treatment for Metastatic Inflammatory Breast Cancer (mIBC)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Breast Inflammatory Carcinoma
• Recurrent Breast Inflammatory Carcinoma
• Stage IV Breast Inflammatory Carcinoma

Interventions

Type	Name	Description
DRUG	Eribulin Mesylate	Given IV
DRUG	Grapiprant	Given PO

Timeline

• Start date: 2021-12-21
• Primary completion: 2024-09-06
• Completion: 2024-09-06
• First posted: 2021-09-10
• Last updated: 2025-06-13
• Results posted: 2025-06-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study