NCT00423150终止2 期
A Phase 2 Study of Temozolomide (SCH 52365) in Subjects With Advanced Aerodigestive Tract Cancers Selected for Methylation of O6-Methyl-Guanine-DNA Methyltransferase (MGMT) Promoter
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 86
- 主要终点
- Tumor Responses (Complete and Partial Response)
研究概览
简要总结
This study is proposed to evaluate the efficacy and safety of temozolomide, an oral anti-cancer agent, in a participant population selected for a biomarker. Participants with colorectal cancer, non-small-cell lung cancer, head and neck cancer, or esophageal cancer will be included.
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
- 否
入选标准
- •Participants must be at least 18 years of age.
- •Participants must have metastatic colorectal cancer (CRC), recurrent or metastatic head & neck (H&N) or esophageal cancer, or locally advanced, inoperable, or metastatic non-small cell lung cancer (NSCLC).
- •Participants must have a tumor sample or a blood sample tested positive for the presence of the biomarker.
- •Participants may have up to 3 prior regimens for CRC, up to 3 prior regimens for NSCLC, up to 2 prior regimens for H&N and esophageal cancer.
- •Participants must have at least one measurable lesion.
- •Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or
- •Participants must have adequate hematologic, renal, and liver functions.
- •Participants must be able to take the study medication capsules orally, or through a feeding tube without the capsules being opened.
- •Participants of childbearing potential must agree to use a medically accepted method of contraception.
排除标准
- •Participants who have received treatment for a second malignancy within 1 year before screening, and are considered to be at risk of relapse within 1 year after screening.
- •Participants with unstable or progressing central nervous system (CNS) metastasis. Participants with known CNS metastasis may be included if a) the subject is asymptomatic, b) there is no requirement for steroids or antiseizure medications, or the required doses are stable, and c) there is no associated midline shift or (in the opinion of the investigator) significant edema.
- •Participants who received prior temozolomide or dacarbazine treatment
研究组 & 干预措施
Temozolomide
Experimental
干预措施: Temozolomide (Drug)
结局指标
主要结局
Tumor Responses (Complete and Partial Response)
时间窗: From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first
Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
次要结局
未报告次要终点
研究者
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