Health Condition 1: null- or any other conditions like cervical, esophageal, metastatic head and neck cancer and Glioma patient receiving Nimotuzumab
Conditions
Interventions
Intervention1: Nimotuzumab: Retrospective, multicentric study to evaluate efficacy and safety of Nimotuzumab in Indian patients with locally advanced head and neck cancer.
Intervention2: Nimotuzumab:
Sponsors
Biocon Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients aged between 18 -75 years. 2. Patients with confirmed squamous cell carcinoma of head and neck or any other conditions like cervical, esophageal, metastatic head and neck cancer and Glioma who are treated with nimotuzumab. 3. Eastern Cooperative Oncology Group (ECOG) performance status 4. Availability of safety data with respect to incidence, severity, duration, recovery pattern and concomitant medication in the case records 5. Availability of details regarding, Physical examination, ECOG, complete blood count, renal function test, liver function test at diagnosis and for subsequent cycle 6. Follow up of at least 6 months from the commencement of therapy 7.Data collected from patients should have completed at least 4 cycles of chemotherapy, with at least 1 scan confirming the response
Exclusion criteria
Exclusion criteria: 1. Females who are pregnant, breast feeding or planning a pregnancy 2. Females of childbearing potential who do not agree to utilize an adequate form of contraception during the study duration. 3.Subject with known active/infections like tuberculosis, hepatitis, (e.g. tuberculosis, pneumonia, histoplasmosis) prior to screening which in opinion of PI might get flared up 4.Subject with history of a known allergy/sensitivity to study drug or its excipients 5. Use of any recreational drugs or history of drug addiction. 6. Any other condition or abnormal findings that, in the investigatorâ??s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To demonstrate efficacy of Nimotuzumab by determining objective response rate, overall survival, progression free survival, metastasis free survival and tumour response rate in locally advanced head and cancer patientTimepoint: after completion of 26 week follow up from the first dose intake | — |
Secondary
| Measure | Time frame |
|---|---|
| To demonstrate efficacy of Nimotuzumab by determining objective response rate, overall survival, progression free survival, metastasis free survival and tumour response rate in locally advanced head and cancer patientTimepoint: after completion of 26 week follow up from the first dose intake | — |
Countries
India
Contacts
Public ContactDr Prameela Rani
Clinsync clinical research Pvt. Ltd.
Outcome results
None listed