NL-OMON34904尚未招募2 期
A Phase II/III Study of MK-0646 Treatment in Combination with Cetuximab and Irinotecan for Patients with Metastatic Colorectal Cancer - MK0646-004
Merck Sharp & Dohme (MSD)0 个研究点目标入组 29 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 29
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Patient has histologically or cytologically confirmed colorectal cancer.
- •2. Patient has at least one measurable lesion greater than or equal to 15 mm.
- •3. Patient has previously failed both irinotecan and oxaliplatin containing regimens and should have progressed on or within 3 months of completing their last line of therapy with objective radiological evidence of progression as verified by previous radiologic scans.
- •Note: Failing oxaliplatin would include failure due to toxicities.
- •4. Patient is male or female, and *18 years of age on the day of signing informed consent.
- •5. Patient has performance status 0-1 on the ECOG Performance Scale.
- •6. Patient has adequate organ function as indicated in the summary of laboratory values, Protocol pag. 23, number 6.
- •7. Female patient of childbearing potential has a negative serum or urine *-hCG pregnancy test at baseline.
- •8. Patient, or patient*s legal representative, has voluntarily agreed to participate by giving written informed consent.
- •9. Patient has archival (recent or remote) tumor available for analysis for biomarker studies.
- •10. Patient has a wtKRAS metastatic colorectal cancer determined by (1) testing at the program central laboratory during the screening period as outlined in the MK0646-004 Assay Charter; or (2) a documented history that the colorectal cancer was determined to be *wtKRAS* by a test conducted at a local laboratory in the period between first diagnosis and consideration for enrollment in the study (see Protocol, page section 3.1.4.1.1)
排除标准
- •1. Patient who has had chemotherapy, radiotherapy, or biological therapy within 2 weeks prior to initial dosing on this study, or whose toxicities from agents administered 2 weeks earlier have not resolved to at least grade 1 or baseline, or who is within 3 weeks from a prior surgery.
- •2. The patient has colorectal cancer whose tumors contain an activating KRAS mutation.
- •3. Patient has experienced intolerable toxicity to irinotecan therapy.
- •4. Patient is < 18 years.
- •5. Patient is known to be Human Immunodeficiency Virus (HIV)-positive.
- •6. Patient has known active Hepatitis B or C.
- •7. Patient is pregnant or breastfeeding, or expecting to conceive or father children within
- •the projected duration of the study.
研究者
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