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
- 105
- 试验地点
- 14
- 主要终点
- Outcome Name: Efficacy will be assessed as BOR (Best Overall Response) by RECIST 1.1 criteria
研究概览
简要总结
This is a prospective, multi-centre, open-label, two-arm, parallel group, active-control, randomized comparative clinical study. The present study will evaluate the efficacyxml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
safety and pharmacokinetics of R-TPR-033 and Erbitux in patients with recurrent loco regional or metastatic squamous cell carcinoma of the head and neck.
The primary outcome measures will be to assess the efficacy as Best overall response rate assessed by RECIST 1.1 criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
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 ≤
- •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 ≤1.5× ULN.
- •9.Serum creatinine ≤1.5× 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
- •Nasopharyngeal cancer
- •Prior treatment with an investigational or approved agent for the purpose of inhibiting HER family members
- •Last anti-tumor therapy within 4 weeks before Cycle 1, Day
- •Diagnosis of concurrent second malignancy or leukemia
- •Active autoimmune disease that is not controlled by non-steroidal anti-inflammatory drugs
- •Symptomatic hypercalcemia.
- •History of bleeding diathesis or coagulopathy other than that due to anticoagulation therapy
- •Active hemoptysis
- •Clinically significant gastrointestinal bleeding within 6 months prior to Cycle 1
- •History of Interstitial Lung Disease
- •Major surgical procedure or significant traumatic injury within approximately 28 days prior to randomization
- •Severe dyspnoea
- •Pre-existing grade 2 or greater motor or sensory neuropathy
- •Women who are pregnant, lactating, or women of childbearing potential who are not using effective contraception.
- •Serious underlying medical condition.
- •Subject participation in another clinical trial within 90 days prior to administration of IP.
- •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.
结局指标
主要结局
Outcome Name: Efficacy will be assessed as BOR (Best Overall Response) by RECIST 1.1 criteria
时间窗: week 18
次要结局
- •To assess efficacy as Disease Control Rate(•To determine disease progression free survival (PFS) rate)
研究者
研究点 (14)
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