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 (Amgen): I
Sponsors
Hetero Biopharma Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients who have completed the 24 weeks of study HCR/III/DENOSOL/12/2019. 2.Patients with ECOG score 0 - 2 3.Patients willing to provide written Informed Consent for extension study, and able to adhere to study schedules and requirements. 4.Patients with screening laboratory tests within the following criteria: a.Haemoglobin >=9.0 g/dL b.WBC >=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 11.5 mg/dL (2 to 2.9 mmol/L) 5.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 untreated or symptomatic brain metastases. 2.Patient with severe renal impairment (creatinine clearance 3.Patients with severe hypocalcaemia (corrected serum calcium of 4.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. 5.Current signs or symptoms of significant, progressive or uncontrolled renal, hepatobiliary, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, vascular, neurologic or cerebral, psychiatric disease that renders the subject incapable of participating in the study. 6.Patients with disorders associated with abnormal bone metabolism including uncontrolled hyperthyroidism or hypothyroidism, hyperparathyroidism or hypoparathyroidism, Pagetâ??s disease, osteomalacia, osteogenesis imperfecta, Cushingâ??s disease or hyperprolactinemia. 7.Patients requiring radiotherapy or surgery to bone metastases; or those currently receiving oral bisphosphonates; or have previously received IV bisphosphonate therapy for treatment of bone metastases. 8.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. 9.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. 10. 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) 11.Patient who has discontinued/withdrawn from the study HCR/III/DENOSOL/12/2019. 12.Patient who has tested positive for anti-denosumab antibodies in previous study HCR/III/DENOSOL/12/2019. 13.Patient who has not benefited from denosumab therapy in study HCR/III/DENOSOL/12/2019 as per Investigatorâ??s discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median time to first on-study Skeletal Related Events (SRE) including hypercalcemia of malignancy associated with bone metastases/lesions during 12 months. Proportion of patients with first on-study Skeletal Related Events (SRE) including hypercalcemia of malignancy associated with bone metastases/lesions for 12 months. Timepoint: 12 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Median time to first & subsequent on-study SREs associated with bone metastases/lesions.Timepoint: 12 months;Proportion of patients with first & subsequent on-study SREs associated with bone metastases/lesions.Timepoint: 12 months;Mean number of on-study SREs associated with bone metastases/lesions.Timepoint: 12 months;Comparative incidence & titers of anti-denosumab antibodies. Timepoint: 12 months;Comparative safety & tolerability for treatment emergent adverse events by monitoring of significant clinical signs & symptoms & laboratory abnormalities during treatment.Timepoint: 12 months | — |
Countries
India
Contacts
Public ContactDr Subhadeep Sinha
Hetero Labs Limited
Outcome results
None listed