Study To Test The Usage of Denosumab In Patients with Cancer spread to Bone

Phase 3

• Conditions: Health Condition 1: C795- Secondary malignant neoplasm of bone and bone marrow

• Registration Number: CTRI/2022/05/042823
• Lead Sponsor: Hetero Biopharma Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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 =2.5 X ULN (=5 X ULN, in case of liver metastases)

f. Alkaline phosphatase levels =5 X ULN

g. Serum creatinine levels =150 µmol/L (=1.7mg/dL)

h. Serum calcium (corrected) levels =8 to =11.5 mg/dL (2 to 2.9 mmol/L)

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

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, Paget’s disease, osteomalacia, osteogenesis imperfecta, cushing’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 <30 mL/min) or receiving dialysis.

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 Gilbert’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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified