To compare and evaluate efficacy and safety of R-TPR-045 / Xgeva® for prevention of skeletal related events inpatients with bone metastases from solid tumours

Phase 3

• Conditions: Health Condition 1: null- Patients with bone metastases from solid tumours

• Registration Number: CTRI/2018/06/014501
• Lead Sponsor: Reliance Life Sciences Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 136

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 <= 2 (after excluding skeletal related morbidity)

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 <=2 times the upper limit of normal

• Alkaline phosphatase levels <=2 times the upper limit of normal

• Serum creatinine <=150 μmol/L (<=1.7mg/dL)

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

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 <6 months

5. Patient with severe renal impairment (creatine clearance <30 mL/min) or receiving

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified