Milaberon in Advanced Solid Tumors: an Open, Multicenter Clinical Study
Recruiting
Phase 2Interventional Study
NSCLCSCLCColorectal CancerPancreas CancerTNBC - Triple-Negative Breast CancerDLBCL - Diffuse Large B Cell LymphomaSquamous Cell Carcinoma of Head and Neck
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
260 (estimated)
Sponsor
Zhejiang Provincial People's Hospital · Other
Who this trial is looking for
This trial is looking for adults with advanced solid tumors who have not had recent treatment. Participants will take a daily oral dose of mirabegron until their disease worsens.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 65 years old.
I have advanced solid tumors that cannot be surgically removed.
I have not received prior treatment for my metastatic solid tumors.
My previous treatment was more than 6 months ago and I have recovered from side effects.
I have at least one measurable tumor.
My overall health status is good.
My major organ functions are normal.
You may not be able to join if
I have received radiation or major surgery in the past 4 weeks.
I have a serious infection or uncontrolled fever.
I have high blood pressure that cannot be controlled.
I have experienced significant bleeding symptoms in the past 3 months.
I have active heart disease.
I have any uncontrolled autoimmune disease.
I have a recent history of substance abuse or psychiatric disorders.
I have a history of tuberculosis infection.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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…
Inclusion Criteria:
* 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;
* For subjects who have previously received neoadjuvant/adjuvant therapy, it takes more than 6 months from the last treatment to relapse or progression;
* Recovery of previous treatment-related AEs to National Cancer Institute Terminology Criteria for Common Adverse Events (NCI-CTCAE)≤ Grade 1 (excluding alopecia);
* According to RECIST 1.1 standard, there is at least one measurable lesion assessed by the research center, and the measurable lesion should be a lesion that has not received local treatment such as radiotherapy (the lesion located in the region of previous radiotherapy can also be regarded as a measurable lesion that meets the requirements if progress is confirmed);
* ECOG physical condition: 0-1;
* Expected survival ≥ 12 weeks;
* The function of major organs is normal, I .e. the following criteria are met (no blood transfusion, albumin, recombinant human thrombopoietin or colony stimulating factor \[CSF\] treatment has been received within 14 days before the first study drug administration): blood test (absolute value of neutrophils ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin concentration ≥ 9g/dL); Liver function test (bilirubin ≤ 1.5 × ULN; aspartate aminotransferase and glutamate aminotransferase ≤ 2.5 ×ULN, AST and ALT ≤ 5 ×ULN in case of liver metastasis); renal function (serum creatinine ≤ 1.5 ×ULN, or creatinine clearance rate (CCr)≥ 60 ml/min); coagulation function, international normalized ratio (INR)≤ 1.5 ×ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT)≤ 1.5 ×ULN; thyroid function, thyroid-stimulating hormone (TSH)≤ the upper limit of normal (ULN); FT3 and FT4 levels should be examined if abnormal, and FT3 and FT4 levels are normal; (11) Women of childbearing age must have a negative serum pregnancy test within 14 days prior to treatment and be willing to use medically approved effective contraception during the study period and within 3 months after the last dose of study medication (e. g. IUDs, contraceptives or condoms; surgical sterilization is required for male subjects whose partner is a woman of childbearing age, alternatively, an effective method of contraception is recommended for the duration of the study and for 3 months after the last study dose.
Exclusion Criteria:
* 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;
* have high blood pressure that cannot be well controlled by antihypertensive drug therapy (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg);
* Within 3 months before treatment, there were obvious clinical bleeding symptoms or obvious bleeding tendency (bleeding\> 30 mL within 3 months, hematemesis, black stool, hematochezia), hemoptysis (fresh blood\> 5 mL within 4 weeks), etc. or a venous/venous thrombotic event within 6 months prior to treatment, such as a cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; or the need for long-term anticoagulant therapy with warfarin or heparin, or the need for long-term antiplatelet therapy (aspirin ≥ 300 mg/day or clopidogrel ≥ 75 mg/day);
* The tumor is found to invade large vascular structures during screening, such as pulmonary artery, superior vena cava or inferior vena cava, and the researchers judge that there is a greater risk of bleeding;
* Active heart disease, including myocardial infarction, severe/unstable angina pectoris, 6 months before treatment. Echocardiography left ventricular ejection fraction \<50%, arrhythmia poorly controlled;
* Uncontrollable pleural effusion, pericardial effusion or ascites requiring frequent drainage after appropriate intervention;
* Presence of any active autoimmune disease or history of autoimmune disease, including but not limited to: autoimmune hepatitis, interstitial pneumonia, pulmonary fibrosis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, thyroid function progression, decreased thyroid function; Note:(1) Subjects whose thyroid function can only be controlled by hormone replacement therapy can be included;(2) Subjects with skin diseases that do not require systemic treatment, such as vitiligo, psoriasis, alopecia, type 1 diabetes, or childhood asthma has been completely resolved, and no intervention can be included after adulthood;(3) Patients with asthma who require medical intervention with bronchodilators cannot be included;
* received treatment with live attenuated vaccine within 28 days prior to the first administration of the study drug;
* The patient has a known history of psychotropic substance abuse, alcohol abuse or drug abuse; a history of definite neurological or psychiatric disorders, including epilepsy or dementia
* tuberculosis infection history;
* known human immunodeficiency virus (HIV) infection;
* Known history of clinically significant liver disease, including viral hepatitis \[Known hepatitis B virus (HBV) carriers must exclude active HBV infection, I .e., HBV DNA positive (\>1 × 104 copies/mL or\> 2000 IU/mL);
* Known hepatitis C virus infection (HCV) and HCV RNA positive (\>1 x 103 copies/mL), or other hepatitis, cirrhosis\];
* Patients with renal injury: GFR\<30 mL/min 1.73m2 or patients requiring hemodialysis
* any other medical condition, clinically significant metabolic, physical, or laboratory abnormality, which, in the investigator's judgment, would reasonably suspect that the patient has a disease or condition that is not appropriate for the study drug (e. g., having seizures requiring treatment, bladder outlet obstruction, anxiety), or would interfere with the interpretation of the study results, or place the patient in a high-risk situation, or patients considered by the investigator to be unsuitable for inclusion.
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