EUCTR2008-004281-71-DE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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 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
- •Key Inclusion Criteria
- •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 (M1) disease
- •At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified
- •RECIST 1.0 guidelines using conventional techniques (CT scan or MRI) or at least 10 mm using 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 of archival tumor tissue confirmed by an Amgen
- •approved central laboratory or an experienced laboratory (local laboratory) per
- •local regulatory guidelines using a validated test method
- •Adequate hematology, renal, hepatic, and coagulation function
- •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 168
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 112
排除标准
- •Key Exclusion Criteria
- •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) or other adjuvant systemic anticancer therapy including but not limited to bevacizumab and anti-EGFr therapy (eg, cetuximab, panitumumab, erlotinib, gefitinib, lapatinib) 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 for the adjuvant or neoadjuvant treatment of
- •rectal cancer
- •Radiotherapy = 14 days prior to randomization. Subjects must have recovered from
- •all radiotherapy-related toxicities.
- •Significant cardiovascular risk
- •Significant bleeding risk
- •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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