Health Condition 1: null- Patients with bone metastases from solid tumours
Conditions
Interventions
Intervention1: R-TPR-045: Recommended dose is 120 mg administered as a single subcutaneous injection
once every 4 weeks into the thigh, abdomen or upper arm till Week 36. All patients should receive t
Sponsors
Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females patients of >=18 -65 years of age. 2. Patients with bone metastases from solid tumours and radiographic evidence of at least one bone metastasis 3. Patients with ECOG PS 4. Able 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. The screening laboratory tests must meet the following criteria: • Haemoglobin >=9.0 g/dL. • WBC >=3.5 x 109/L • Neutrophils >=1.5 x 109/L • Platelets >=100 x 109/L • Serum transaminase • Alkaline phosphatase levels • Serum creatinine 6. Subjects must have the ability to understand and comply with instructions and be able to complete study-related forms and questionnaires. 7. Men and women of childbearing potential must be using adequate birth control measures, as discussed with the study doctor and should agree to continue such precautions for 6 months after receiving the last injection of study medication 8. Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential.
Exclusion criteria
Exclusion criteria: 1. Patients with multiple myeloma 2. Patients who had disorders associated with abnormal bone metabolism including uncontrolled hyper- or hypothyroidism or Pagetâ??s disease; untreated or symptomatic brain metastases 3. Patients currently receiving therapy with chronic systemic corticosteroid administration; or received calcitonin, parathyroid hormone related peptides, mithramycin, strontium ranelate, or gallium nitrate within 8 weeks of random assignment 4. Patients with life expectancy 5. Patient with severe renal impairment (creatine clearance dialysis. 6. Patients with severe, untreated hypocalcaemia 7. Patient with rare hereditary problems of fructose intolerance 8. Prior use of Denosumab or ongoing treatment with bisphosphonates. 9. Patients on hormone replacement therapy for menopausal symptoms. 10. Hypersensitivity to the active substance or to any of the excipients 11. Patient with invasive dental procedures (e.g., tooth extraction, dental implants, oral surgery in last 6months before screening), poor oral hygiene or other pre-existing dental disease 12. Current use or known history of systemic (injectable or oral) corticosteroid medication use in last 6 months before screening Visit. 13. Patients with planned radiation therapy or surgery to bone 14. Patients with current or previous osteonecrosis or osteomyelitis of the jaw, any planned invasive dental procedure during the study 15. Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis etc.). 16. Current smoker or smoking history within 12 months prior to the Screening Visit. 17. Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study: Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen; Unstable angina; New York Heart Association (NYHA) greater than/equal to grade 2 congestive heart failure 18. Myocardial infarction within 6 months of study enrollment; History of stroke within 6 months of study enrollment; Unstable symptomatic arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia are eligible); Clinically significant peripheral vascular disease; Uncontrolled diabetes; Serious active or uncontrolled infection 19. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications. 20. Inability to comply with study and/or follow-up procedures. 21. Subjects who are HIV, HBsAg, HCV test positive. 22. 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 participati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary - Incidence of first on-study SRE including hypercalcemia of malignancy associated with bone metastases/lesions in patients with bone metastases from solid tumours receiving R-TPR-045 / Xgeva® Co-primary - Median time to first on-study SRE including hypercalcemia of malignancy associated with bone metastases/lesions in patients with bone metastases from solid tumours receiving R-TPR-045 / Xgeva®.Timepoint: Primary - Till Week 24 Co-primary - Median time to first on-study SRE (till Week 36) | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of bone repair â?? change from baseline in nuclear bone scanTimepoint: week 12,24 and week 36;Evaluation of safetyTimepoint: across the study;Incidence/Proportion of patients with first and subsequent on-study SREs associated with bone metastases/lesionsTimepoint: week 24 and 36;Mean number of on-study SREs / patient associated with bone metastases/lesionsTimepoint: week 12, 24 and week 36;Pharmacodynamic assessment- Percentage changeTimepoint: baseline to week 4,8,12, 24 and 36;Pharmacokinetic parameters (Cmax, AUC0-t and other PK parameter)Timepoint: for single dose and multiple dose (at steady state);Quality of life assessment- HRQoLTimepoint: baseline at week 12,24 and 36;Time to first and subsequent on-study SREs associated with bone metastases/lesionsTimepoint: Week 12, 24 and 36 | — |
Countries
India
Contacts
Public ContactSwapnil Ramakant Mirgal
Reliance Life Sciences Pvt. Ltd
Outcome results
None listed