EUCTR2008-004281-71-IT进行中（未招募）1 期
A Randomized, Multicenter, Phase 2 Study to Compare the Efficacy of Panitumumab in Combination With mFOLFOX6 to the Efficacy of Bevacizumab in Combination With mFOLFOX6 in Patients With Previously Untreated, KRAS Wild-Type, Unresectable, Metastatic Colorectal Cancer - 20070509
Amgen Inc.0 个研究点目标入组 280 人开始时间: 2009年5月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 280
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
- 性别
- All
入选标准
- •Man or woman ≥ 18 years of age at the time the informed consent is obtained
- •ECOG performance status of 0 or 1
- •Histologically or cytologically-confirmed adenocarcinoma of the colon or rectum in
- •subjects with unresectable metastatic disease
- •At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST
- •guidelines using conventional techniques (CT scan or MRI) or spiral CT scan. Lesion
- •must not be chosen from a previously irradiated field, unless there has been documented
- •disease progression in that field after irradiation and prior to randomization. All sites of
- •disease must be evaluated ≤ 28 days prior to randomization
- •Wild-type KRAS tumor status confirmed by central laboratory assessment of paraffinembedded
- •tumor tissue from the primary tumor or metastasis
- •Adequate hematology, renal, hepatic, and coagulation function (see Section 4.1.3)
- •Magnesium ≥ lower limit of normal
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •History of prior or concurrent central nervous system (CNS) metastases
- •History of other malignancy, except:
- •Malignancy treated with curative intent and with no known active disease present
- •for ≥ 3 years prior to randomization and felt to be at low risk for recurrence by the
- •treating physician
- •Adequately treated non-melanomatous skin cancer or lentigo maligna without
- •evidence of disease
- •Adequately treated cervical carcinoma in situ without evidence of disease
- •Prostatic intraepithelial neoplasia without evidence of prostate cancer
- •Prior chemotherapy or other systemic anticancer therapy for the treatment of metastatic
- •colorectal carcinoma including but not limited to bevacizumab and anti-EGFr therapy (eg,
- •cetuximab, panitumumab, erlotinib, gefitinib, lapatinib)
- •Prior adjuvant chemotherapy (including oxaliplatin therapy) for the treatment of colorectal
- •cancer ≤ 52 weeks prior to randomization with the following exceptions:
- •Subjects may have received prior fluoropyrimidine therapy if administered solely
- •for the purpose of radiosensitization Radiotherapy ≤ 14 days prior to randomization. Subjects must have recovered from all
- •radiotherapy-related toxicities.
- •Significant cardiovascular risk (see Section 4.2.4)
- •Significant bleeding risk (see Section 4.2.4)
- •History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of
- •interstitial lung disease on baseline CT scan
- •Active inflammatory bowel disease or other bowel disease causing chronic diarrhea
- •(defined as ≥ CTC grade 2, [CTCAE version 3.0])
- •Peripheral sensory neuropathy (≥ CTC grade 2 [CTCAE version 3.0]
研究者
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