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RECRUITING
NCT06534762
PHASE2

Milaberon in Advanced Solid Tumors: an Open, Multicenter Clinical Study

Sponsor: Zhejiang Provincial People's Hospital

View on ClinicalTrials.gov

Summary

This study is an exploratory study, and all the drugs involved are listed drugs. The dosage of mirabetron is selected according to the basis of previous research. The clinical recommend dose of this product is 50mg/day, and the dose used in this study is 100mg/day, which is larger than the clinical commonly used dose. The main adverse reactions of this product are urinary tract infection and rapid heartbeat. In the clinical study, we will focus on the urine routine and heart-related adverse events of the subjects, and deal with the adverse events in time. Subjects were given mirabeeron 100mg/day orally once a day in the morning until disease progression. When there are related or possible related side effects of the study drug mirabeeron, and according to NCI-CTCAE V 5.0, when subjects have more than or equal to grade 3 related toxicity, the administration should be delayed until grade 2 or lower to baseline, and the dose will be reduced by 50%, and subsequent dose increase is not allowed. If the pre-dose criteria are not met within 28 days, the drug will be permanently discontinued.

Official title: Efficacy and Safety of Milaberon in Combination With Standard Therapy in Advanced Solid Tumors: an Open, Multicenter, Clinical Study

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2024-07-15

Completion Date

2028-07-01

Last Updated

2024-08-02

Healthy Volunteers

No

Interventions

BIOLOGICAL

Mirabegron

To explore the efficacy and safety of milaberon combined with standard treatment in advanced solid tumors

Locations (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China