Health Condition 1: C795- Secondary malignant neoplasm of bone and bone marrow
Conditions
Interventions
Intervention1: Intas Denosumab of Intas
Pharmaceuticals Ltd: Dose: 120 mg/1.7 mL
Frequency: every 4 weeks
Duration of treatment: 24 weeks
Control Intervention1: Xgeva of Amgen: Dose: 120 mg/1.7 mL
Duration of treatment: 24 weeks
Sponsors
Intas Pharmaceuticals Ltd Biopharma Division
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults with greater than or equal to 18 years. 2. Histological or Cytological confirmation of a. Breast adenocarcinoma or b. Prostate cancer or c. Non-small cell lung cancer. 3. Radiographic evidence of at least 1 bone metastasis (Confirmed by X-ray, computed tomography, magnetic resonance imaging or bone scan). 4. Eastern Cooperative Oncology Group performance status less than or equal to 2. 5. Willing to provide written informed consent and comply with protocol requirements. 6. Able to communicate well with the investigator, to understand and comply with the requirements of the study. 7. Patients of child bearing potential must agree to use acceptable methods of contraception (as per investigator discretion) during the study. Female patients of child bearing potential must agree to use contraceptive methods for at least 5 months after the last dose of the drug.
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to denosumab or prior use of denosumab. 2. Any of the following oral/dental conditions: a. Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw. b. Active dental or jaw condition which requires oral surgery. c. Planned invasive dental procedure. d. Non-healed dental or oral surgery. 3. Administration of intravenous (IV) bisphosphonates, fluoride, or strontium for osteoporosis within the last 1 year or oral bisphosphonates treatment for osteoporosis in last 3 months. 4. Currently enrolled in or has not yet completed at least 30 days (or 5 half-lives, whichever is longer) since ending earlier investigational device or drug trial(s), or patient is receiving another investigational agent(s). 5. Planned bone surgery or radiation to the bone. 6. Life expectancy less than 6 months. 7. Serum calcium levels less than or equal to 8 mg per dl. 8. Estimated creatinine clearance less than or equal to 30 ml per min. 9. Females with a positive pregnancy test at screening or lactating females 10. Tested positive for HIV, HCV or HBsAg or known to be tested positive. 11. Uncontrolled hypertension (Blood pressure more than 140 by 90 mm of Hg) (Patient on stable antihypertensive medication for more than 3 months with controlled hypertension will be eligible) 12. Any other significant medical condition which in the opinion of the investigator increases the safety risk if patient participate in the trial 13. Clinically relevant ECG abnormality that affects the successful completion of patient treatment in the trial as per investigator. 14. Recent history (within the past 1 year) of Myocardial infarction or cerebral stroke or patients with NYHA III or IV heart failure 15. History of drug or alcohol abuse within the 12 months prior to dosing 16. Any of the following abnormal investigational values a. General: Any laboratory abnormality which, in the opinion of the Investigator, would prevent the patient from safely completing the study or interfere with the interpretation of the study results. b. Liver transaminases: i. AST or SGOT greater than or equal to 2.0 x upper limits of normal ULN ii. ALT or SGPT greater than or equal to 2.0 x ULN iii. Alkaline phosphatase and bilirubin greater than or equal to 1.5 x ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the efficacy of Intas Denosumab (test product) as compared to Xgeva (reference product) in patients with solid tumours with bone metastasis.Timepoint: screening, week 12 and week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of the pharmacokinetic, immunogenicity and safety of the test product as compared to the reference product.Timepoint: Pharmacokinetic Assessment: Day 0 and at week 4, 8, 12, 16, 20 and 24 Immunogenicity Assessment: screening, Day 0, at week 4, 12, 20 and 24 Safety Assessments: throughout the study | — |
Countries
India
Contacts
Public ContactMr Prashant Modi
Lambda Therapeutic Research Ltd
Outcome results
None listed