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
ATCO Pharma Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
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 must be between 18 and 65 years of age with life expectancy = 3 months having recurrent and/or metastatic disease.
- •2. ECOG Performance Status less than or equal to 2.
- •3. Histologically confirmed squamous cell carcinoma of the head and neck. Primary sites include, oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, and paranasal sinus.
- •4. 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].
- •5. 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.
- •6. Measurable lesion as per Revised RECIST criteria (1.1 version)
- •7. 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.
- •8. Willing to practice birth control during and for 2 months after treatment.
- •9. Patients must be tested negative for HIV, HbsAg and pregnancy (for female subjects).
排除标准
- •1. Patients with major illness including active cardiac, hepatic, endocrine, renal or psychiatric disorders inadequately controlled with current therapy
- •2. Patients with brain metastases or primary CNS malignancies. Radiological evaluation of brain metastasis will be performed only if the patient has symptoms
- •3. Prior EGFR-targeting therapies, prior investigational agents for recurrent or metastatic disease, other concurrent investigational agents, other concurrent anticancer treatment.
研究者
相似试验
进行中（未招募）
2 期
A Clinical Study to evaluate the efficacy and safety of NRC-AN-019 in cancer patients failing prior standard therapiesCTRI/2013/06/003768ATCO Pharma Limited
已完成
不适用
A Phase II clinical trial to evaluate the efficacy and safety of intra-arterial infusion chemotherapy for head and neck squamous cell carcinomahead and neck squamous cell carcinomaJPRN-UMIN000019865Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University40
撤回
不适用
A phase II clinical Trial for evaluating efficacy and safety of PDR001(Spartalizumab) in concurrent plus consolidation versus consolidation only in addition to standard chemotherapy in unresectable stage III NSCLC patients(PASTURE)KCT0004933Yonsei University Health System, Severance Hospital200
进行中（未招募）
不适用
Clinical Trial testing the combination of MK-5172 and MK-8742 with Ribavirin in people with Hepatitis CHepatitis C Virus Genotype 2, 4, 5 and 6MedDRA version: 16.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 16.1Level: LLTClassification code 10047457Term: Viral hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2013-002169-21-GBMerck Sharp & Dohme Corp.100
进行中（未招募）
1 期
A Phase II Clinical Trial to Evaluate the Efficacy of the Infusion of Autologous CD34+ Cells Transduced with a Lentiviral Vector Carrying the FANCA Gene (Orphan Drug) in Patients with Fanconi Anemia Subtype AFanconi anemia (subtype A)MedDRA version: 20.0Level: LLTClassification code 10055206Term: Fanconi's anemiaSystem Organ Class: 100000004850EUCTR2018-002502-31-ESRocket Pharmaceuticals, Inc.5