EUCTR2008-004752-77-FR进行中（未招募）1 期
A Phase 2 Study of Panitumumab Plus Irinotecan Followed by Panitumumab PlusAMG 479 in Subjects With Metastatic Colorectal Carcinoma Expressing Wild Type KRAS and Refractory to Oxaliplatin- or Irinotecan- and Oxaliplatin-containing Regimens to Evaluate Mechanisms of Acquired Resistance to Panitumumab
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
- 76
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
- •Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum
- •Subjects with wild-type KRAS tumor status confirmed by central laboratory assessment
- •Radiographic evidence of disease progression while on or = 6 months after treatment with irinotecan- and oxaliplatin- or oxaliplatin-based chemotherapy for mCRC
- •Radiographic measurement of tumor burden done within 28 days prior to Day 1 (start of treatment with investigational product)
- •At least 1 uni-dimensionally measurable lesion = 20 mm using conventional CT or MRI or = 10 mm by spiral CT per modified RECIST. 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 enrollment. All sites of disease must be evaluated
- •At least 1 tumor (metastatic lesion or unresected primary tumor) that is amenable to core needle biopsy, as determined by the clinician who will perform the biopsy
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix E)
- •Male or female = 18 years of age at the time of informed consent
- •Willing to undergo two core biopsy procedures of tumors (metastasis or unresected primary)
- •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
- •Prior treatment with anti-EGFR antibodies (eg, panitumumab, cetuximab) or EGFR small molecule inhibitors (eg, erlotinib, gefitinib)
- •Prior treatment with monoclonal antibodies directed against IGF-1R
- •Use of systemic chemotherapy and radiotherapy = 21 days before enrollment
- •Use of any antibody therapy (eg, bevacizumab) = 42 days before enrollment
- •Use of anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules = 30 days before enrollment
- •Known UGT1A1 polymorphisms predisposing to increased irinotecan toxicity
- •History of irinotecan intolerance that may interfere with planned treatment
- •History of interstitial lung disease (eg, pneumonitis, pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan
- •Known positive test(s) for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic active hepatitis B infection
- •Any co-morbid disease or condition that could increase the risk of toxicity (eg, significant ascites, significant pleural effusion)
- •Any uncontrolled concurrent illness (eg, infection, bleeding diathesis) or history of any medical condition that may interfere with the interpretation of the study results
- •Major surgical procedure = 28 days before enrollment or minor surgical procedure = 14 days before enrollment. Subjects must have recovered from surgery related toxicities.
研究者
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