EUCTR2007-004722-25-BE进行中（未招募）不适用
A Phase 1b/2 Trial of AMG 655 in Combination with Panitumumab in Subjects with Metastatic Colorectal Cancer
Amgen Inc.0 个研究点目标入组 65 人开始时间: 2007年12月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 65
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
- •Disease Related
- •- Histologically or cytologically confirmed metastatic adenocarcinoma of the
- •colon or rectum
- •- Radiographically documented disease progression per modified RECIST
- •during or following treatment with fluoropyrimidine, irinotecan, and/or
- •oxaliplatin chemotherapy for mCRC. Progressive disease must be
- •documented during or = 6 months after the last dose of the most recent
- •chemotherapy regimen prior to enrollment
- •- At least 1 uni-dimensionally measurable lesion measuring = 20 mm in one
- •dimension per modified RECIST (Appendix D). 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
- •- Available archived paraffin-embedded tumor tissue from the primary tumor or
- •metastasis for submission to the central laboratory (see Section 7.7)
- •Demographic
- •- Man or woman = 18 years of age at the time of enrollment
- •Laboratory (performed = 7 days before enrollment)
- •- Hematologic function within the following limits:
- •- Absolute neutrophil count (ANC) > 1.0 x 109 cells/L
- •- Platelets = 100 x 109/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
- •- Metabolic function within the following limits:
- •- Amylase = 2 x ULN
- •- Lipase = 2 x ULN
- •- Magnesium = lower limit of normal
- •- Negative pregnancy test = 72 hours before enrollment (for woman of
- •childbearing potential only)
- •Medications
- •- Subject must have received 1, 2, or 3 prior chemotherapy regimens for
- •- Competent to comprehend, sign, and date the IEC/IRB approved written
- •informed consent
- •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
- •Disease Related
- •- History of other primary cancer, unless:
- •- Curatively resected non-melanomatous skin cancer
- •- Curatively treated cervical carcinoma in situ
- •- Other primary solid tumor curatively treated with no known active disease
- •present and no treatment administered for = 5 years before enrollment
- •Medications
- •- Prior treatment with anti-EGFr inhibitors (eg, cetuximab, erlotinib, gefitinib),
- •unless treatment was received in the adjuvant setting = 6 months before
- •- Use of systemic chemotherapy and radiotherapy = 30 days before enrollment
- •- Use of prior anti-tumor therapies with a short serum half-life (less than
- •1 week) including prior experimental agents or approved anti-tumor small
- •molecules = 30 days before enrollment
- •- Use of anti-tumor therapies with a longer serum half-life (eg, bevacizumab)
- •including prior experimental or approved protein/antibodies = 42 days before
- •- Any investigational agent or therapy = 30 days before enrollment
- •- Known allergy or hypersensitivity to any component of panitumumab and/or
- •- History of or known presence of central nervous system (CNS) metastases
- •- 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 = CTC grade 2 [CTCAE version 3.0])
- •- Known positive test for human immunodeficiency virus (HIV) infection,
- •hepatitis C virus, acute or chronic 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) or history of any
- •medical condition that may interfere with the interpretation of the study results
- •- Major surgical procedure (requiring general anesthesia) = 28 days or minor
- •surgical procedure (excluding central venous catheter placement) = 14 days
- •before enrollment. Subjects must have recovered from surgery related toxicities.
- •- Other investigational procedures are excluded
- •- Subject is currently pregnant or breast feeding
- •- Man or woman of childbearing potential who is not willing to use adequate
- •contraceptive precautions during treatment and for 6 months (for women) or
- •1 month (for men) after the last investigational product administration.
- •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
研究者
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