EUCTR2008-001751-21-IT进行中（未招募）不适用
A Randomized, Phase 1b/2 Trial of AMG 102 or AMG 479 in Combination with Panitumumab versus Panitumumab Alone in Subjects with Wild-Type KRAS Metastatic Colorectal Cancer - 20060447
Amgen Inc.0 个研究点目标入组 144 人开始时间: 2008年12月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 144
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 A life expectancy estimate of ≥ 3 months ECOG 0 or 1 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 during or following prior treatment with irinotecan and/or oxaliplatin based chemotherapy for mCRC At least 1 uni-dimensionally measurable lesion ≥ 20 mm in one dimension per modified RECIST (CT or MRI) Adequate hematology, renal, and hepatic function Magnesium ≥ lower limit of normal Subjects with known diabetes (Type 1 or 2) must have adequate glycemic function, as follows: - Must be controlled with a glycosylated hemoglobin (HgbA1c) of < 8.0% - Documented fasting blood sugars < 160 mg/dL
- •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
- •Participation in a phase 3 randomized study of panitumumab in combination with chemotherapy, regardless of treatment assignment Prior treatment with anti-EGFr inhibitors (eg, panitumumab, cetuximab, erlotinib, gefitinib), unless treatment was received in the adjuvant setting ≥ 6 months before enrollment Prior treatment with c-Met, IGF-IR, or IGF-IIR inhibitors Prior treatment with either AMG 102 or AMG 479 Use of experimental or approved systemic chemotherapy or radiotherapy ≤ 21 days before enrollment Use of experimental or approved targeted therapies ≤ 30 days before enrollment History of prior or concurrent central nervous system (CNS) metastases History of other primary cancer, unless: - Curatively resected non-melanomatous skin cancer - Curatively treated cervical carcinoma in situ - Other primary solid tumor treated with curative intent and no known active disease present for ≥ 5 years before enrollment History of interstitial lung disease (eg, pneumonitis, pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment Active inflammatory bowel disease or other active bowel disease causing chronic diarrhea (defined as ≥ grade 2 per CTCAE version 3.0) Any co-morbid disease or condition that could increase the risk of toxicity (eg, significant ascites, significant pleural effusion) Serious or non-healing wound ≤ 35 days before enrollment Major surgical procedure ≤ 35 days before enrollment or minor surgical procedure ≤ 14 days before enrollment. Subjects must have recovered from surgery related toxicities. Central venous catheter placement, fine needle aspiration, thoracentesis, or paracentesis is not considered a major or minor surgical procedure.
研究者
相似试验
进行中（未招募）
1 期
A Randomized, Phase 1b/2 Trial of AMG 102 or AMG 479 in Combination with Panitumumab versus Panitumumab Alone in Subjects with Wild-Type KRAS Metastatic Colorectal CancerWild-Type KRAS Metastatic Colorectal CancerMedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerEUCTR2008-001751-21-FRAmgen Inc.153
进行中（未招募）
不适用
Panitumumab Combination Study With AMG 102 or AMG 479 in Wild-type KRAS mCRCWild-Type KRAS Metastatic Colorectal CancerMedDRA version: 13.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-001751-21-ATAmgen Inc.153
进行中（未招募）
1 期
Panitumumab Combination Study With AMG 102 or AMG 479 in Wild-type KRAS mCRCWild-Type KRAS Metastatic Colorectal CancerMedDRA version: 14.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2008-001751-21-BEAmgen Inc.153
进行中（未招募）
不适用
A Randomized, Phase 1b/2 Trial of AMG 102 or AMG 479 in Combination with Panitumumab versus Panitumumab Alone in Subjects with Wild-Type KRAS Metastatic Colorectal Cancer.----------------------------------------------------------------------------------------------------Ensayo aleatorizado de fase 1b/2 de AMG 102 o AMG 479 en combinación con panitumumab frente a panitumumab en monoterapia en sujetos con cáncer colorrectal metastásico con KRAS no mutado.Wild-Type KRAS Metastatic Colorectal Cancer.---------------------------------------------------------cáncer colorrectal metastásico con KRAS no mutadoMedDRA version: 9.1Level: LLTClassification code 10052362Term: Metastatic colorectal cancerEUCTR2008-001751-21-ESAmgen Inc.144
进行中（未招募）
1 期
Panitumumab Combination Study With AMG 102 or AMG 479 in Wild-type KRAS mCRCWild-Type KRAS Metastatic Colorectal CancerMedDRA version: 16.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864EUCTR2008-001751-21-GBAmgen Inc.153