Health Condition 1: null- Patients with recurrent loco regional or metastatic squamous cell carcinoma of the head and neck.
Conditions
Interventions
Intervention1: R-TPR-033: Manufactured by Reliance Life Sciences Pvt. Ltd.
Dose and Frequency: Subjects will receive initial dose of 400 mg/m2 R-TPR-033(over 2 hours) followed by weekly doses of 250 mg/ m2 (over 1 hour)
Route: IV
Duration: 24 weeks
Control Intervention1: Erbitux: Manufactured by Eli Lilly & Co.
Dose and Frequency: Subjects will receive initial dose of 400 mg/m2 (over 2 hours) followed by weekly doses of 250 mg/ m2 (over 1 hour)
Duration: 24 weeks
Sponsors
Reliance Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of 18-65 years of age. 2.Histologically or cytologically confirmed recurrent locoregional or metastatic squamous-cell carcinoma of the head and neck that is not suitable for local therapy 3.Patients must have documented progression of platinum-based chemotherapy for R/M disease 4.At least one lesion that is measurable by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 5.Eastern Cooperative Oncology Group (ECOG) performance status 6.Estimated life expectancy >4 months 7.ANC >=1.5x109/L, Platelets >=100x109/L, Hemoglobin >9.0 g/dL, Serum Creatinine 8.INR and aPTT 9.Serum creatinine =50 mL/min 10.Patient or Legally Acceptable Representative able to comprehend and give written informed consent for the study and willing to come for follow-up visits as per protocol requirements
Exclusion criteria
Exclusion criteria: 1. Nasopharyngeal cancer 2. Prior treatment with an investigational or approved agent for the purpose of inhibiting HER family members 3. Last anti-tumor therapy within 4 weeks before Cycle 1, Day 1. 4. Diagnosis of concurrent second malignancy or leukemia 5. Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs 6. Symptomatic hypercalcemia. 7. History of bleeding diathesis or coagulopathy other than that due to anticoagulation therapy 8. Active hemoptysis 9. Clinically significant gastrointestinal bleeding within 6 months prior to Cycle 1 10. History of Interstitial Lung Disease 11. History of severe (Grade 3 or 4) allergic or hypersensitivity reaction to therapeutic antibodies. 12. Clinical or Radiological evidence of Primary central nervous system malignancy or 13. Major surgical procedure or significant traumatic injury within approximately 28 days prior to randomization 14. Severe dyspnoea 15. Pre-existing grade 2 or greater motor or sensory neuropathy 16. Women who are pregnant, lactating, or women of childbearing potential who are not using effective contraception. 17. Serious underlying medical condition. 18. Subject participation in another clinical trial within 90 days prior to administration of IP. 19. Previous use of non-human monoclonal antibody therapy 20. Current severe, uncontrolled acute or chronic systemic disease Any other condition which investigator feels would pose a significant hazard to subject, if IP is administered.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome Name: Efficacy will be assessed as BOR (Best Overall Response) by RECIST 1.1 criteriaTimepoint: week 18 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To assess efficacy as Disease Control Rate â?¢ To determine disease progression free survival (PFS) rate â?¢ Objective Response Rate â?¢ To determine duration of objective response To determine time to progression â?¢ To evaluate Overall Survival (OS) â?¢ Pharmacokinetics of R-TPR-033 and ErbituxR â?¢ Evaluation of safety â?¢ Pharmacodynamic studies of anti-EGFR activity â?¢ To study immunogenicity Timepoint: week 24 | — |
Countries
India
Contacts
Public ContactDr Prashant Pandya
Reliance Life Sciences Pvt.Ltd
Outcome results
None listed