A Study to Investigate Safety, Efficacy and Immunogenicity of Denosumab in Patients with Bone Metastases from Advanced Malignancies
- Conditions
- Health Condition 1: C795- Secondary malignant neoplasm of bone and bone marrow
- Registration Number
- CTRI/2023/01/049158
- Lead Sponsor
- Intas Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Participants are eligible to be included in the study only if all of the following criteria apply:1Participants must sign an ICF indicating that the participant understands the purpose and procedures required for the study and is willing to participate in the study.2 Man or woman participant must be more than or equal to 18 years of age at the time of signing the informed consent.3 Participants with histologically or cytologically confirmed advanced malignancies including solid tumors, and current or prior radiographic evidence of at least one bone metastasis.4 Participants must be receiving or have finished standard chemotherapy/immunotherapy/hormonal therapy/targeted therapy for current phase of primary malignancy.5 Eastern Cooperative Oncology Group (ECOG) performance status more than or equal to 2.6 Participants who are medically stable on the basis of physical examination, medical history, vital signs and 12-lead ECG performed at screening. Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participant source documents and initialed by the investigator.7 Participants who are medically stable on the basis of clinical laboratory tests performed at screening. If the results of the serum biochemistry panel including hematology, urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participants source documents and initialed by the investigator.8 A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies-• Is not a woman of childbearing potential (WOCBP).OR • Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of less than 1 per cent during the intervention period and for at least 5 months after the last dose of study intervention. The investigator should evaluate the effectiveness and the potential for contraceptive method failure (eg, noncompliance, recently initiated) of the contraceptive method in relationship to the first dose of study intervention.• A WOCBP must have a negative highly sensitive serum beta-human chorionic gonadotropin (beta-hCG) test at screening and urine beta-hCG test at baseline.• If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.• Additional requirements for pregnancy testing during and after study intervention n are located in Section 8.1.9.The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.9 Male participants are eligible to participate if they agree to the following during the intervention period and for at least 5 months after the last dose of study intervention:• Must agree not to donate sperm for the purpose of reproduction.PLUS EITHER• Be abstinent from heterosexual or homosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.OR• Must agree to use contracep
Any potential participant who meets any of the following criteria will be excluded from participating in the study:1 Documented medical history of clinically significant bone metabolism disorder, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances or any other medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol specified assessments.2 Current or past history of denosumab or bisphosphonate (IV or oral) for treatment of bone metastasis in advanced malignancies. 3 Participant with current evidence of any of the following oral/dental conditions:(a) active dental or jaw condition which requires oral surgery, (b) current evidence or previous history of osteonecrosis or osteomyelitis of the jaw (c) non-healed dental/oral surgery (d) any planned invasive dental procedure during the study.4 Planned radiation therapy or surgery to bone.5 Known allergies, hypersensitivity, or intolerance to denosumab or its excipients (refer to the locally approved prescribing information of denosumab-Intas).6 Hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) or HIV positive, at Screening.7 Participant has a life expectancy of less than 6 months.
8 Participant has taken any disallowed therapies.6.8 before the planned first dose of study intervention.
9 Currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug trial(s), or participants is receiving another investigational agent(s).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety profile of denosumab Intas in participants with bone metastases from advanced malignancies.Timepoint: Frequency and incidence of adverse events and serious adverse events throughout study from visit 1 to visit 8.
- Secondary Outcome Measures
Name Time Method To evaluate the efficacy of denosumab-Intas in <br/ ><br>participants with bone metastases from advanced malignanciesTimepoint: Proportion of participants with first one study skeletal-related events (SRE) <br/ ><br>throughout study at baseline (visit 2) till end of study (visit 8). <br/ ><br>Note: Skeletal related event is defined as at least one of the following: Pathological fracture (excluding fracture from severe trauma), radiation therapy to bone, or surgery to bone or spinal cord compression