Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
ID06534762

Efficacy and Safety of Milaberon Combined With Standard Therapy 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

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the use of milaberon, combined with standard treatments, in adults with advanced solid tumors that cannot be removed surgically. The study focuses on evaluating the safety and effectiveness of a higher dose of mirabegron (100mg/day), which is above the usual clinical dose, with particular attention to urinary tract infections and heart-related side effects. This is an open, multicenter clinical study sponsored by Zhejiang Provincial People's Hospital. Participants receive 100mg of mirabegron orally once daily in the morning until their disease progresses. If severe side effects (grade 3 or higher) related to mirabegron occur, dosing is paused until symptoms improve to grade 2 or lower, then resumed at half the dose; dose increases are not allowed. If recovery criteria are not met within 28 days, the drug is permanently stopped. The study includes various cohorts with different cancer types receiving standard chemotherapy or immunotherapy regimens alongside the investigational drug. During the study, participants will undergo regular evaluations including blood tests, urine analysis, heart monitoring, and physical exams to assess treatment effects and side effects. Researchers will measure outcomes such as overall response rate and dose-limiting toxicities over three years. Participants are monitored for disease control, survival, and progression. The study duration varies with ongoing assessments until disease progression or unacceptable toxicity occurs.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients voluntarily participate in the study, sign informed consent, and have good compliance
  • Aged between 18 and 65 years inclusive
  • Solid tumors confirmed 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
  • Recovery from prior treatment-related adverse events to grade 1 or lower (excluding alopecia)
  • At least one measurable lesion by RECIST 1.1 not previously treated locally
  • ECOG physical condition score of 0 or 1
  • Expected survival of at least 12 weeks
  • Normal major organ function including blood, liver, kidney, coagulation, and thyroid function
  • Women of childbearing age must have negative pregnancy test and agree to use effective contraception during and 3 months after study
Not Eligible

You will not qualify if you...

  • Treatment within 4 weeks before study with tumor radiotherapy, major surgery not fully healed, or beta-3 adrenoceptor agonists
  • Allergy or contraindication to mirabegron or its excipients
  • Active malignant tumors in past 3 years except cured local tumors
  • Symptomatic brain or meningeal metastases
  • Severe infection or fever above 38.5°C during screening
  • Uncontrolled high blood pressure (≥150/100 mmHg)
  • Recent significant bleeding events or clotting disorders
  • Tumor invading large blood vessels with high bleeding risk
  • Active heart disease or poorly controlled arrhythmia
  • Uncontrollable pleural, pericardial effusion, or ascites
  • Active autoimmune disease or history requiring systemic treatment
  • Live attenuated vaccine within 28 days before treatment
  • History of substance abuse or significant psychiatric disorders
  • Tuberculosis infection history
  • Known HIV infection
  • Significant liver disease or viral hepatitis with active infection
  • Severe renal impairment or requiring dialysis
  • Other medical conditions judged unsuitable by investigators

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Until disease progression or discontinuation

Participants receive milaberon 100mg orally once daily in the morning combined with standard therapy for advanced solid tumors until disease progression or unacceptable toxicity occurs.

Visits every 3 weeks during chemotherapy cycles; frequency may vary depending on the standard therapy regimen

Trial Site Locations

Total: 1 location

1

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Actively Recruiting

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Research Team

L

Liu Yang, M.D.

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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Published Research Related To This Trial

Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.

Hyuna Sung, Jacques Ferlay, Rebecca L Siegel...

https://pubmed.ncbi.nlm.nih.gov/33538338