EUCTR2008-001751-21-GB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 Cancer
Amgen Inc.0 个研究点目标入组 153 人开始时间: 2010年7月20日最近更新:
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
- 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
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)
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 t
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