CTRI/2009/091/000115已完成1 期
An Open Label, Multicenter Phase I/II Study Of Selective Cyclin Dependent Kinase Inhibitor P276-00 In Combination With Radiation In Subjects With Recurrent And/Or Locally Advanced Squamous Cell Carcinoma Of Head And Neck
Piramal Life Sciences0 个研究点目标入组 23 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
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. Disease specifications:
- •a. Phase I component: Radiation naïve subjects with histologically and/ or cytologically confirmed squamous cell carcinoma of head and neck that is non-metastatic, unresectable and recurrent. Radiation naïve subjects with non-recurrent, non-metastatic, unresectable, disease can also be enrolled if he/she is intolerant to and/or unwilling for chemoradiotherapy involving standard cytotoxic agents (e.g. cisplatin, carboplatin, oxaliplatin, 5-FU, taxanes, methotrexate, etc)
- •b. Phase II component: Radiation naïve subjects with non-recurrent, non-metastatic, unresectable, locally advanced squamous cell carcinoma of head and neck who are intolerant to and/or unwilling for chemoradiotherapy involving standard cytotoxic agents (e.g. cisplatin, carboplatin, oxaliplatin, 5-FU, taxanes, methotrexate, etc).
- •2. Treatment specifications:
- •a. Phase I Component: subjects must not have received any treatment (chemotherapy, targeted or biologic agents, radiotherapy, surgery etc) for the recurrent disease.
- •b. Phase II Component: The subjects must not have been curatively operated for the disease.
- •3. Subjects must have completed any prior chemotherapy, biologic/targeted anti-cancer therapy or surgery at least 4 weeks (at least 6 weeks for nitrosureas and mitomycin C) before initiation of protocol treatment and subjects must have recovered (to grade < or =1) from the toxic effects from any prior therapy
- •4. Measurable disease as per RECIST criteria.
- •5. Age > or =18 years
- •6. ECOG (Eastern Cooperative Oncology Group) performance status < or = 2
- •7. Life expectancy of at least 12 weeks
- •8. Normal organ and marrow function as defined below:
- •Hemoglobin > or = 100 g/L, Leukocytes >or =3 x 109/L, Absolute Neutrophil Count (ANC) > or = 1.5 x 109/L, Platelets > or =75 x 109/L, Total bilirubin < or=1.5 X institutional Upper Limit of Normal (ULN), AST(SGOT) < or = 2.5 X institutional ULN, ALT(SGPT)< or =2.5 X institutional ULN, Creatinine< or = 1.5 X institutional ULN
排除标准
- •1. Nasopharyngeal carcinoma
- •2. Any other investigational drug therapy within 1 month prior to day 1 of study drug administration or non-recovery (to grade less than equal to 1) from adverse effects of the investigational agent received prior to this period.
- •3. History of unstable angina or myocardial infarction or stroke within 6 months prior to initiation of protocol treatment.
- •4. QTcF more than 450 msec
- •5. Uncontrolled inter-current illness or any condition that would limit compliance with study requirements.
- •6. Subjects known to be suffering from infection with HIV, Tuberculosis, Hepatitis C or Hepatitis B.
- •7. Pregnancy or lactation.
- •8. Women of childbearing potential or men, not agreeing to use at least 2 approved methods of contraception (one of which being a barrier method) unless they are surgically sterilised.
研究者
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