EUCTR2006-003169-15-GR进行中（未招募）1 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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Subjects must have one of the following histologically or cytologically confirmed tumor types:
- •a. CRC: metastatic disease.
- •b. NSCLC: locally advanced, inoperable, or metastatic disease. Eligible histologies include (but are not restricted to) squamous cell, adenocarcinoma, adenosquamous carcinoma, and large cell carcinoma.
- •c. H & N cancer: metastaatic disease, including squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx.
- •d. Esophageal cancer: metastatic disease, including (but not restricted to) squamous cell carcinoma and adenocarcinoma, and also including cancers at the gastroesophageal junction.
- •2. Subjects must have a tumor sample available from initial diagnosis or later and a serum/plasma sample taken during the screening period. The available tumor samples can be from the biopsy or surgical resection of primary or metastatic lesions.
- •3. Subjects must demonstrate methylated MGMT promoter in the most recent tumor tissue sample or in the serum/plasma sample.
- •4. Subjects must have relapsed or recuurent disease with no other potentially curative treatment option available in the opinion of the investigator.
- •5. Subjects must meet the requirements listed below regarding their prior chemotherapy, biological therapy, immunotherapy, or targeted therapy for metastatic disease. In addition to the prior therapy limits below, subjects may also have received adjuvant ot neoadjuvant therapy.
- •a. CRC: no more than 3 prior regimens.
- •b. NSCLC: no more than 2 prior regimens.
- •c. H & N cancer: no more than 1 prior regimen.
- •d. Esophageal cancer: no more than 1 prior regimen.
- •6. Subjects must have resolution of all clinically significant toxic effects (excluding alopecia, acne, skin rash) of any prior surgery, radiotherapy, biological therapy, immunotherapy, targeted therapy or chemotherapy to Grade 7. Subjects must have at least one measureable lesion, as defined by Response Evaluation Criteria in Solid Tumors (RESIST). If the subject has received radiation therapy, this measurable lesion must be outside the area of prior radiation.
- •8. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- •9. Subjects must have adequate hematologic, renal, and liver function, as demonstrated by laboratory values performed within 14 days, inclusive, prior to administration of study drug:
- •a. Absolute neutrophil count >/= 1,500/mm3
- •b. Platelet coount >/= 100,000/mm3
- •c. Hemoglobin >/= 9 g/dl
- •d. Blood urea nitrogen(BUN)/urea and serum creatinine e. Total serum bilirubin f. Alkaline phosphatase of </= 2 x ULN, or in the presence of documented liver or bone metastases, alkaline phosphatase </= 5 x
排除标准
- •1. Subjects who have had any other type of cancer within 5 years of study start, with the exception of surgically cured carcinoma in-situ of the cervix and basal cell carcinoma of the skin.
- •2. Subjects with known (past or present) brain or leptomeningeal metastasis.
- •3. Subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease that would make implementation of the protocol difficult.
- •4. Subjects who received prior temozolomide or dicarbazine treatment.
研究者
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