Grapiprant and Eribulin for the Treatment of Metastatic Inflammatory Breast Cancer
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|ClinicalTrials.gov Identifier: NCT05041101|
Recruitment Status : Recruiting
First Posted : September 10, 2021
Last Update Posted : June 30, 2022
|Condition or disease||Intervention/treatment||Phase|
|Breast Inflammatory Carcinoma Recurrent Breast Inflammatory Carcinoma Stage IV Breast Inflammatory Carcinoma||Drug: Eribulin Mesylate Drug: Grapiprant||Phase 1 Phase 2|
I. To determine the safety and efficacy of grapiprant and eribulin combination treatment for the patient with metastatic inflammatory breast cancer (mIBC).
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.
I. To evaluate the changes in the tumor microenvironment after the proposed treatment.
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 (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib/II Study of Grapiprant (IK-007) and Eribulin Combination Treatment for Metastatic Inflammatory Breast Cancer (mIBC)|
|Actual Study Start Date :||November 4, 2021|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2025|
Experimental: Treatment (grapiprant, eribulin mesylate)
Patients receive grapiprant PO BID on day 1-21 and eribulin mesylate IV over 5 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Drug: Eribulin Mesylate
- Incidence of dose-limiting toxicity [ Time Frame: Up to 21 days ]
- Clinical benefit rate (CBR) [ Time Frame: Up to 24 weeks ]Defined as complete response (CR) + partial response (PR) + stable response (> 24 weeks). The CBR will be summarized by frequency and percentage with 95% exact confidence intervals for all patients and by doses.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05041101
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Naoto T. Ueno, MD 713-792-8754 email@example.com|
|Principal Investigator: Naoto T. Ueno, MD|
|Principal Investigator:||Naoto T Ueno||M.D. Anderson Cancer Center|