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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorZhejiang Provincial People's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Patients voluntarily participate in the study, sign informed consent, and have good compliance;

18-65 years old (including 18 and 65 years old);

solid tumors confirmed by histology and/or cytology, and advanced metastatic tumors that are not feasible for surgical resection;

Has not received previous systemic antitumor drug therapy for metastatic/recurrent solid tumors;

Disqualifiers

Received the following treatment within 4 weeks before treatment: radiotherapy of tumor, major surgical operation or wound has not been completely healed, β3 adrenoceptor agonist and corresponding clinical research drugs;

those who have contraindications to Miraberon: those who are allergic to Miraberon or any of its excipients;

Active malignant tumors in the past 3 years, except for tumors participating in the study and local tumors that have been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, breast carcinoma in situ, etc;

symptomatic brain or meningeal metastases; Severe infection (such as intravenous infusion of antibiotics, antifungals, or antivirals) within 4 weeks before treatment, or fever of unknown origin> 38.5°C during screening/first dose;

Trial design

Treatments tested in this trial

  • Mirabegron

Treatment groups

260 Participants
are divided into 1 treatment group