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

NCT06534762 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2024-08-02

No results posted yet for this study

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.

Conditions

  • NSCLC
  • SCLC
  • Colorectal Cancer
  • Pancreas Cancer
  • TNBC - Triple-Negative Breast Cancer
  • DLBCL - Diffuse Large B Cell Lymphoma
  • Squamous Cell Carcinoma of Head and Neck

Interventions

BIOLOGICAL

Mirabegron

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

Sponsors & Collaborators

  • Zhejiang Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Liu Yang, M.D. · Zhejiang Provincial People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-15
Primary Completion
2026-07-01
Completion
2028-07-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06534762 on ClinicalTrials.gov