Health Condition 1: C795- Secondary malignant neoplasm of bone and bone marrow
Conditions
Interventions
Intervention1: Injection Hetero-Denosumab: Injection: 120 mg/1.7 mL (70 mg/mL) solution in a single dose
vial every 4 weeks for 24 weeks
Control Intervention1: Injection Reference-Denosumab (Amgens):
Sponsors
Hetero Biopharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients of >= 18 - 65 years of age. 2. Patients with current/ prior radiographic (X-ray, CT or MRI) evidence of at least one bone metastases from solid tumors. 3. Patients with ECOG score 0 - 2 4. Patients with ability to understand the study procedures and the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements. 5. Patients with screening laboratory tests within the following criteria: a. Hemoglobin >=9.0 g/dL b. White blood cells >=3.5 X 109/L c. Absolute neutrophil count >=1.5 X 109/L d. Platelets >=100 X 109/L e. Serum transaminase levels f. Alkaline phosphatase levels g. Serum creatinine levels h. Serum calcium (corrected) levels >=8 to 6. Women of childbearing potential should neither become pregnant nor lactate and must be using barrier methods of birth control measures during the study period and for 6 months after receiving the last injection of study medication.
Exclusion criteria
Exclusion criteria: 1. Patients with history of hypersensitivity to the denosumab or to drugs with similar chemical structures, or to any of the excipients, or to murine proteins. 2. Previous exposure to denosumab (Prolia, Xgeva, or biosimilar denosumab). 3. Prior intravenous bisphosphonate treatment or current/prior oral bisphosphonates for treatment of bone metastases. 4. Patients who had disorders associated with abnormal bone metabolism including uncontrolled hyperthyroidism or hypothyroidism (except subjects on stable thyroid hormone replacement therapy for last one year), hyperparathyroidism or hypoparathyroidism, Pagetâ??s disease, osteomalacia, osteogenesis imperfecta, cushingâ??s disease or hyperprolactinemia. 5. Patients with untreated or symptomatic brain metastases. 6. Patients receiving systemic corticosteroids; or received calcitonin, parathyroid hormone related peptides, mithramycin, strontium ranelate, or gallium nitrate within 8 weeks of randomization. 7. Patients requiring radiotherapy or surgery to bone metastases. 8. Patient with severe renal impairment (creatine clearance 9. Patients with current or previous osteonecrosis or osteomyelitis of the jaw or non-healed dental/oral surgery or any planned invasive dental procedure during the study. 10. Severe and/or uncontrolled conditions which could compromise participation in the study: Uncontrolled blood pressure ( >140/90 mm of Hg); Unstable angina; Congestive heart failure (NYHA grade 3 or more, History of myocardial infarction or stroke within previous 6 months of randomization; Symptomatic arrhythmia requiring medication. 11. Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease that renders the subject incapable of participating in the study. 12. Patients with current or past infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). 13. History or presence of any medical or psychiatric condition or disease, or clinically significant laboratory abnormality, physical examination findings or any other condition that, in the opinion of the Investigator, may place the subject at unacceptable risk for study participation and may prevent the subject from completing the study. 14. History of cirrhosis of the liver or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbertâ??s syndrome or asymptomatic gallstones). 15. Patients with a history or suspicion of unreliability, poor cooperation or non-compliance with medical treatment. 16. Participation in any clinical study of an investigational product within the previous 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion patients with first on-study Skeletal Related Events (SRE) including hypercalcemia of malignancy associated with bone metastases/lesions.Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Median time to first on-study Skeletal Related Events (SRE) including hypercalcemia of malignancy associated with bone metastases/lesions.Timepoint: 24 weeks;Time to first and subsequent on-study SREs associated with bone metastases/lesions.Timepoint: Week 12 and Week 24;Proportion of patients with first and subsequent on-study SREs associated with bone metastases/lesions.Timepoint: Week 12 and Week 24;Mean number of on-study SREs associated with bone metastases/lesions.Timepoint: Week 12 and Week 24;Pharmacokinetic parameters comparison of Cmax, AUC0-t, AUC0-28day.Timepoint: After First Dose Administration;Pharmacodynamic assessment - Percentage change in uNTx/Cr in patients with bone metastases from solid tumors.Timepoint: From Baseline to Week 4, 8, 12 and 24.;Comparative incidence and titers of anti-Denosumab antibodies.Timepoint: Week 12 and Week 24;Comparative safety and tolerability for treatment emergent adverse events.Timepoint: Throughout the study period | — |
Countries
India
Contacts
Public ContactDr Shubhadeep Sinha
Hetero Drugs Limited
Outcome results
None listed