EUCTR2008-001751-21-AT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
Amgen Inc.0 个研究点目标入组 153 人开始时间: 2008年11月18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
- 153
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
- •Inclusion Criteria for Parts 1 and 2
- •Disease related:
- •-Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum.
- •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 (see Section 7.1.1 for information on KRAS testing and Section 7.5.1.1 for tumor tissue requirements)
- •-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 (CT or MRI) or= 10 mm (spiral CT) in one dimension per modified RECIST v1.0 (Appendix F). 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.
- •-Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Appendix E)
- •Demographic:
- •-Man or woman = 18 years of age
- •-A life expectancy estimate of = 3 months
- •Laboratory:
- •To be performed = 7 days before enrollment, unless otherwise specified:
- •Hematologic function within the following limits:
- •-Absolute neutrophil count (ANC) = 1.0 x 10*9 cells/L
- •-Platelets = 100 x 10*9/L
- •Renal function within the following limits:
- •-Creatinine < 2.0 mg/dL
- •Hepatic function within the following limits:
- •-Aspartate aminotransferase (AST) = 2.5 x ULN (= 5 x ULN if liver
- •metastases)
- •-Alanine aminotransferase (ALT) = 2.5 x ULN (= 5 x ULN if liver
- •metastases)
- •-Bilirubin = 2 x ULN
- •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
- •Negative pregnancy test = 3 days before enrollment (for woman of childbearing potential only)
- •Inclusion Criteria for Part 3:
- •Unless otherwise specified, subjects must meet the following criteria before unblinding in the IVRS may occur (see Section 7.2 for details and time between part 2 and 3).
- •Disease Related:
- •Radiographic evidence of disease progression per modified RECIST v1.0, clinical
- •progression, or intolerability during treatment (cohort 3 confirmed upon unblinding)
- •ECOG 0 or 1
- •Laboratory:
- •Hematologic function within the following limits:
- •-Hemoglobin = 8 g/dL
- •-Absolute neutrophil count (ANC) = 1.0 x 10*9 cells/L
- •-Platelets = 100 x 10*9/L
- •Renal function within the following limits:
- •-Creatinine < 2.0 mg/dL
- •Hepatic function within the following limits:
- •-Aspartate aminotransferase (AST) = 2.5 x ULN (= 5 x ULN if liver metastases)
- •-Alanine aminotransferase (ALT) = 2.5 x ULN (= 5 x ULN if liver metastases)
- •-Bilirubin = 1.5 x ULN
- •Magnesium: For subjects presenting with hypomagnesemia, hypomagnesemia must be = Grade 2
- •-Glycosylated hemoglobin (HgbA1c) of = 8.0%
- •No history or evidence of thrombosis or vascular ischemic events within the last 12 months before enrollment into part 3, such as deep venous thrombosis, pulmonary embolism, transient ischemic attack, cerebral infarction, or myocardial infarction.
- •Are the trial subjects under 18? no
- 另有 5 项未显示
排除标准
- •Exclusion Criteria - Parts 1&2
- •Disease Related:
- •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
- •Medications:
- •-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
- •-Known allergy or hypersensitivity to any component of panitumumab, AMG 102, or AMG 479
- •-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)
- •-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)
- •-Serious or non-healing wound = 35 days before enrollment
- •-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 = 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.
- •-Other investigational procedures or drugs (ie, participation in another clinical study) are excluded = 30 days before enrollment
- •-Subject of child-bearing potential is evidently pregnant (eg, positive HCG
- •test) or is breast feeding
- •-Man or woman of childbearing potential who is not willing to use adequate contraceptive precautions during treatment and for 6 months after the last dose of the last investigational product (men and women). Adequate contraceptive precautions includes double barrier contraceptive methods (eg, diaphragm and condom) or abstinence
- •-Previously enrolled into this study
- •-Subject unwilling or unable to comply with study requirements
- •-Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
研究者
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