Status:
COMPLETED
Efficacy and Safety of MW032 and Xgeva® in Subjects With Bone Metastases From Solid Tumors
Lead Sponsor:
Mabwell (Shanghai) Bioscience Co., Ltd.
Conditions:
Bone Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A multi-center, randomized, double-blind, parallel controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW032 and Xgeva® in patients with bone metastases from solid tumo...
Detailed Description
This is A multi-center, randomized, double-blind, parallel controlled Phase III clinical trial. The primary objective is to evaluate the clinical efficacy of MW032 and Xgeva® in patients with bone me...
Eligibility Criteria
Inclusion
- Pathological confirmed malignant tumors (except hematological tumors);
- Bone metastasis diagnosed by imaging (bone X-ray, CT scanning or magnetic resonance scanning) or pathology (bone biopsy) can be examined within 3 months before signing the informed consent,according to 《The expert consensus on clinical diagnosis and treatment of bone metastases and bone related diseases of malignant tumors (2014)》；
- No limited of gender,age ≥ 18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2;
- Estimated survival time was more than 6 months;
- Subjects must have adequate organ function at baseline as defined below:① hematology: neutrophils ≥ 1,500/mcL, platelets ≥ 75,000/mcL, hemoglobin ≥ 80 g / L; ② renal function: creatinine (CR) clearance rate ≥ 30 ml / min; ③ Liver function: serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were less than or equal to 2.0 × upper normal limit (ULN) in subjects without liver metastasis; ALT and AST were less than or equal to 5.0 × ULN in subjects with liver metastasis; serum total bilirubin was less than or equal to 1.5 × ULN; ④ serum calcium (albumin correction) was more than or equal to 2.0 mmol / L (8.0 mg / dl) but less than or equal to 2.9 mmol / L (11.5 mg / dl). Note: calcium supplements should not be used at least 8 hours before serum calcium determination in screening period;
- Subjects has understood the nature and purpose of the study, as well as the research procedure, and the subject has signed the written informed consent;
Exclusion
- Subjects with diseases not suitable for the study,in the Investigator's opinion (according to the subject's report or medical record review), such as:Other malignant tumors (different from the malignant solid tumors required in this study protocol) occurred within 3 years before enrollment, and in the active period;Other diseases affecting bone metabolism, such as vitamin D deficiency rickets, osteomalacia and primary osteoporosis, hyperparathyroidism, osteitis deformans, etc. (excluding osteoporosis);Human immunodeficiency virus or Treponema pallidum infection;Unstable liver disease, active period of hepatitis B virus or hepatitis C virus infection;Other serious or unstable physical or mental disorders.
- Brain metastasis.
- Oral and dental diseases: previous or current evidence of osteomyelitis or necrosis of the jaw; acute dental or mandibular diseases, need to be treated oral surgery; planned invasive dental surgery; failed dental or oral surgery.
- Subjects with bone metastases need radiotherapy or surgery.
- Previous treatment with denosumab.
- Patients who had received any kind of intravenous or oral bisphosphonates before administration of the first study drug.
Key Trial Info
Start Date :
March 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2022
Estimated Enrollment :
708 Patients enrolled
Trial Details
Trial ID
NCT04812509
Start Date
March 20 2020
End Date
January 28 2022
Last Update
February 24 2023
Active Locations (1)
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1
Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China, 100011