CTRI/2015/06/005909Other3 期
Prospective, multi-centric, randomized open-label, two arm, parallel group, active-control, comparative clinical study to evaluate efficacy, safety and pharmacokinetics of R-TPR-033 / Erbitux® in patients with recurrent locoregional or metastatic squamous cell carcinoma of the head and neck
试验速览
- 阶段
- 3 期
- 状态
- Other
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 <=2.
- •6.Estimated life expectancy >4 months
- •7.ANC >=1.5x109/L, Platelets >=100x109/L, Hemoglobin >9.0 g/dL, Serum Creatinine <= 1.5 ULN and Total bilirubin <= 1.5 mg/dL.
- •8.INR and aPTT <=1.5Ã? ULN.
- •9.Serum creatinine <=1.5Ã? ULN, or creatinine clearance >=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
排除标准
- •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.
研究者
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