Actively Recruiting
Milaberon in Advanced Solid Tumors: an Open, Multicenter Clinical Study
Led by Zhejiang Provincial People's Hospital · Updated on 2024-08-02
260
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Milaberon in Advanced Solid Tumors: an Open, Multicenter Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily participate in the study, sign informed consent, and have good compliance
- Aged 18 to 65 years (inclusive)
- Confirmed solid tumors by histology or cytology, with advanced metastatic tumors not suitable for surgery
- No previous systemic antitumor drug therapy for metastatic or recurrent solid tumors
- More than 6 months since last neoadjuvant or adjuvant therapy if previously treated
- Previous treatment-related adverse events recovered to Grade 1 or lower (excluding alopecia)
- At least one measurable lesion per RECIST 1.1 assessment, including lesions not previously locally treated or with confirmed progression
- ECOG physical condition score of 0 or 1
- Expected survival of 12 weeks or more
- Normal major organ function meeting specified blood, liver, kidney, coagulation, and thyroid criteria
- Women of childbearing age must have a negative pregnancy test within 14 days before treatment and agree to effective contraception during and 3 months after the study
- Male subjects with female partners of childbearing age must use effective contraception during the study and for 3 months after last dose
You will not qualify if you...
- Received radiotherapy, major surgery not fully healed, or beta-3 adrenoceptor agonists within 4 weeks before treatment
- Allergy to mirabegron or its excipients
- Active malignant tumors within past 3 years except for cured local tumors like skin basal cell carcinoma or carcinoma in situ
- Symptomatic brain or meningeal metastases
- Severe infection needing intravenous antibiotics, antifungals, or antivirals within 4 weeks or fever above 38.5°C during screening
- Poorly controlled high blood pressure (systolic 65 150 mmHg or diastolic 65 100 mmHg)
- Recent significant bleeding or thrombotic events within specified time frames
- Tumor invasion of major blood vessels with high bleeding risk
- Active heart disease including recent myocardial infarction, unstable angina, reduced heart function, or uncontrolled arrhythmia
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
- Active or history of autoimmune disease except controlled thyroid disorders or resolved skin diseases
- Received live attenuated vaccine within 28 days before first study drug dose
- History of substance abuse or neurological/psychiatric disorders like epilepsy or dementia
- Tuberculosis infection history
- Known HIV infection
- Significant liver disease or active hepatitis B or C infection
- Renal injury with GFR <30 mL/min/1.73m2 or need for hemodialysis
- Other medical conditions or abnormalities judged unsuitable by investigator for safety or study interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
L
Liu Yang, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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