CTRI/2024/06/068269
Not yet recruiting
Phase 3
Comparative pharmacokinetic, pharmacodynamic, safety, efficacy and immunogenicity study of VBDNSM01 (Virchow Denosumab) versus Xgeva (Amgen Denosumab) in patients with bone metastasis from solid tumours - Nil
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Virchow Biotech Private Limited
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male or female with \= 18 to \= 75 years.
- •2\.Histological or Cytological confirmation of Breast adenocarcinoma or Prostate cancer or Non\-small cell lung cancer.
- •3\.Radiographic evidence of atleast 1 bone metastasis (Confirmed by X\-ray, computed tomography, magnetic resonance imaging or bone scan).
- •4\.Eastern Cooperative Oncology Group performance status \=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 atleast 5 months after the last dose of the drug.
Exclusion Criteria
- •1\.History of hypersensitivity to denosumab or prior use of denosumab.
- •2\.Any of the following oral/dental conditions:
- •Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw.
- •Active dental or jaw condition which requires oral surgery.
- •Planned invasive dental procedure.
- •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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 3
Comparative biosimilar rituximab vs Ristova in Rheumatoid ArthritisHealth Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecifiedCTRI/2022/10/046212Virchow Biotech Private Limited
Completed
Not Applicable
Comparative pharmacokinetics, pharmacodynamics, efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukaemia (ALL)ISRCTN75734403Medac GmbH (Germany)32
Active, not recruiting
Not Applicable
Pharmacokinetics, efficacy, tolerability and safety evaluation of the therapy with subcutaneous immunoglobulin in the treatment of hypo or agammaglobulinaemic patients. Open label phase II/III study - NDHypogammaglobulinaemia or agammaglobulinaemiaMedDRA version: 9.1Level: LLTClassification code 10060384MedDRA version: 9.1Level: LLTClassification code 10001471EUCTR2010-020167-20-ITKEDRIO
Not yet recruiting
Not Applicable
This is a study to optimise the dosing regimen for Vancomycin so that patient response to the drug can be improved.CTRI/2023/02/049473Prof Nusrat Shafiq
Completed
Phase 1
Study to evaluate the effects of new drug of diabetes mellitus in healthy volunteers.CTRI/2016/01/006507Cadila Pharmaceuticals Ltd36