NCT00904852撤回1 期
A Phase 1, Multicenter, Open-Label, Dose Escalation Study of Tandutinib (Formerly MLN518) in Combination With Temozolomide and Bevacizumab Following Concurrent Radiation Therapy and Temozolomide in the Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 30
- 主要终点
- Maximum tolerated dose of tandutinib, adverse events, serious adverse events and dose limiting toxicities, clinical laboratory values and vital sign measurements
研究概览
简要总结
This is a safety study of tandutinib in combination with temozolomide and bevacizumab after people have received radiation therapy and temozolomide treatment. This study will determine the maximum safe dose of tandutinib when combined with temozolomide and bevacizumab and evaluate the safety of the combination treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of glioblastoma multiforme
- •Received radiotherapy for glioblastoma multiforme
- •Patients who have not had previous treatments for glioblastoma multiforme (except for surgery, radiation and temozolomide therapy)
- •Females that are postmenopausal for at least 1 year prior to screening visit
- •18 years of age and older
排除标准
- •Other brain cancers that are not diagnosed as glioblastoma multiforme
- •female patients who are lactating or are pregnant
- •HIV positive and/or any other active infection requiring therapy
- •Known hepatitis B or hepatitis C infection
- •Diagnosed or treated any other cancer within 2 years before the first dose
- •History of cardiovascular conditions and/or vascular disease
- •Allergic to any component of bevacizumab
研究组 & 干预措施
Tandutinib, bevacizumab, and temozolomide
Experimental
tandutinib in combination with temozolomide and bevacizumab following concurrent radiation therapy and temozolomide treatment.
干预措施: Tandutinib, bevacizumab, and temozolomide (Drug)
结局指标
主要结局
Maximum tolerated dose of tandutinib, adverse events, serious adverse events and dose limiting toxicities, clinical laboratory values and vital sign measurements
时间窗: Cycle 1 days 1, 8, 15, and 22. Cycle 2 -6 days 1 and 15
次要结局
未报告次要终点
研究者
相似试验
已完成
1 期
A Trial of Tivozanib (AV-951) in Combination With Capecitabine (Xeloda®) in Subjects With Advanced Solid TumorsAdvanced Solid TumorsLocally Advanced or Metastatic Breast or Colorectal CancerNCT01306630AVEO Pharmaceuticals, Inc.24
已完成
2 期
A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To BoneNeoplasm MetastasisPalliative CareNCT00545129Pfizer59
已完成
1 期
T-DM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast CancerMetastatic Breast CancerNCT02073916Jenny C. Chang, MD24
已完成
1 期
Tivantinib and Bevacizumab in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by SurgerySolid NeoplasmNCT01749384National Cancer Institute (NCI)12
进行中（未招募）
2 期
Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal CancersColorectal CarcinomaGastric AdenocarcinomaGEJ AdenocarcinomaEsophageal AdenocarcinomaGallbladder CarcinomaCholangiocarcinomaNCT04430738Seagen, a wholly owned subsidiary of Pfizer40