CTRI/2019/06/019649招募中2 期
A Phase II Clinical Study to evaluate the efficacy and safety of NRC-2694-A in patients with recurrent Head and Neck Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 22
- 主要终点
- •Tumor response will be assessed by CT or MRI at baseline and at end of every 6-week (Before start of Preceding cycle) after the start of treatment until disease progression
研究概览
简要总结
The study will be conducted in patientswith recurrent or metastatic squamous-cell carcinoma of the head and neck andfor whom cisplatin/carboplatin and fluorouracil regimen is planned. The primary objective of the study is to evaluate the efficacy of NRC-2694-A tablets when combined with platinum regimen compared toplatinum regimen alone in terms of Progression Free Survival (PFS). The secondary objective is to compare the objectiveresponse, stabledisease rates, duration of response, time to response, median survival, overall survival of patients and safety & tolerability of the study drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients must be between 18 and 65 years of age with life expectancy ≥ 3 months having recurrent and/or metastatic disease.
- •ECOG Performance Status less than or equal to
- •Histologically confirmed squamous cell carcinoma of the head and neck.
- •Primary sites include, oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, and paranasal sinus.
- •Adequate bone marrow reserve (WBC at least 3,000/mm3, neutrophil count ≥2000/mm3, platelet count ≥ 1,00,000mm3 and hemoglobin level 8.0 g/dL), renal function (normal serum creatinine), liver function [total bilirubin level ≤2 times upper normal limit (UNL) and serum transaminases levels ≤ 2.5 times UNL/ ≤ 5 times for liver metastasis and/or obstructive jaundice].
- •Patients must not have received chemotherapy within 30 days (6 weeks for nitrosoureas or mytomycin C) and radiotherapy within 3 weeks and must not have undergone surgery within 2 weeks before dosing.
- •Measurable lesion as per Revised RECIST criteria (1.1 version)
- •Subjects who received primary radiation therapy are eligible if the locoregional recurrence is in the field of radiation and occurred at least 6 months after therapy completion.
- •If the recurrence is outside the field of radiation, subject will be eligible at least 3 months after therapy completion.
- •Willing to practice birth control during and for 2 months after treatment.
- •Patients must be tested negative for HIV, HbsAg and pregnancy (for female subjects).
排除标准
- •Patients with major illness including active cardiac, hepatic, endocrine, renal or psychiatric disorders inadequately controlled with current therapy
- •Patients with brain metastases or primary CNS malignancies.
- •Radiological evaluation of brain metastasis will be performed only if the patient has symptoms
- •Prior EGFR-targeting therapies, prior investigational agents for recurrent or metastatic disease, other concurrent investigational agents, other concurrent anticancer treatment.
结局指标
主要结局
•Tumor response will be assessed by CT or MRI at baseline and at end of every 6-week (Before start of Preceding cycle) after the start of treatment until disease progression
时间窗: 1, 42, 84 and 216 days
次要结局
- Overall survival is defined as the time from the date of randomization to the date of death (regardless of the cause of death combines). Percentage of patients in each arm achieving Objective response (complete and partial response), duration of response (DOR; time from first confirmed object response to disease progression), time to response (TRR; time from randomization to first confirmed objective response)(day 1 and day 216)
研究者
研究点 (22)
Loading locations...
相似试验
已完成
2 期
Study of Nivolumab in Combination With Ipilimumab Versus Nivolumab in Combination With Ipilimumab Placebo in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and NeckHead and Neck CancerNCT02823574Bristol-Myers Squibb425
已完成
2 期
Reirradiation and Erbitux in the HNSCCHead and Neck Cancer Squamous CellNCT01237483Groupe Oncologie Radiotherapie Tete et Cou50
进行中（未招募）
2 期
A Clinical Study of SI-B001 in Combination With Paclitaxel/Docetaxel in the Treatment of Recurrent and Metastatic HNSCCHead and Neck Squamous Cell CarcinomaNCT05054439Sichuan Baili Pharmaceutical Co., Ltd.45
进行中（未招募）
2 期
A Clinical Study to Evaluate the Efficacy and Safety of SI-B001 in the Treatment of Recurrent and Metastatic HNSCCHead and Neck Squamous Cell CarcinomaNCT05044897Sichuan Baili Pharmaceutical Co., Ltd.11
Unknown
2 期
A Phase II Study of an Anti-Tumor Immunotherapy Regimen Comprised of Pegylated Interferon-Alpha 2b and HyperAcute Melanoma Vaccine for Subjects With Advanced MelanomaMelanomaNCT00746746Ochsner Health System30