EUCTR2015-004370-14-NL进行中（未招募）1 期
89Zr-AMG211 PET imaging in patients with relapsed/refractory gastrointestinal adenocarcinoma before and during treatment with AMG 211 - 89Zr-AMG211 PET imaging study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 35
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
- •Subject may already have received AMG 211 cIV infusion
- •Subject has provided informed consent to imaging study prior to initiation of any study-specific activities/procedures
- •Male or Female = 18 years of age at the time of informed consent
- •Pathologically documented, diagnosed GI adenocarcinoma (including but not limited to esophageal, gastric, small intestine, colorectal, or
- •pancreatic cancers) that has failed standard treatments or for which standard curative or palliative measures do not exist or are no longer
- •At least 1 measurable tumor lesion per modified irRC
- •oIn case we do not find any uptake in metastatic liver lesions in the first set of patients on the 89Zr-AMG211 PET scan, than subsequent
- •patients need to have at least 1 measurable tumor lesion outside the liver
- •Archival tumor tissue available or is willing to undergo biopsy of a tumor lesion before the start of treatment
- •Adequate hematological, renal, and liver function as follows:
- •oAbsolute neutrophil count (ANC) > 1500/mm3 (1.5 × 109/L)
- •oPlatelet count > 100,000 mm3 (100 × 109/L)
- •oWhite blood cell (WBC) count > 3 × 109/L
- •oHemoglobin > 9.0 g/dL
- •oAST and ALT < 3.0 × the upper limit of normal (ULN)
- •oAlkaline phosphatase (ALP) = 2.5 × ULN
- •oTotal bilirubin (TBL) < 1.5 × ULN (unless subject has suspected Gilbert’s syndrome or extrahepatic cause by increased indirect bilirubin fraction)
- •oCreatinine clearance > 50 mL/min calculated by Cockroft-Gault
- •oLipase/amylase < 1.5 x ULN
- •oProthrombin time, partial thromboplastin time, and international normalized ratio (INR) = 1.5 × ULN
- •Life expectancy = 3 months, in the opinion of the investigator
- •Karnofsky Performance Status = 70%
- •Body weight = 45 kg
- •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 35
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •History of allergy or reaction to any component of the AMG 211 formulation
- •Malignancy other than GI adenocarcinoma requiring current therapy
- •Evidence of uncontrolled systemic disease (other than GI adenocarcinoma)
- •Active infection or prior use of IV antibiotics for treatment of infection within 2 weeks prior to starting therapy with AMG 211
- •Corrected QT interval (QTc) = 500 milliseconds at screening
- •Hepatitis B and/or C based on the following results:
- •o Positive Hepatitis B Surface Antigen (HepBsAg) (indicative of chronic Hepatitis B or recent acute Hepatitis B)
- •o Negative HepBsAg and positive Hepatitis B core antibody: Hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable
- •Hepatitis B virus DNA suggests occult Hepatitis B.
- •o Positive Hepatitis C virus antibody (HepCAb) Hepatitis C virus RNA by PCR is necessary. Detectable Hepatitis C virus RNA suggests chronic Hepatitis C
- •Positive results for human immunodeficiency virus (HIV)
- •Major surgery within 28 days of study day 1
- •Prophylactic anti-infection vaccination within 1 month prior to starting therapy with AMG 211. Therapeutic vaccination for cancer or infection
- •within 3 months prior to starting therapy with AMG 211.
- •Currently receiving treatment in another investigational device or drug study, or less than 28 days since ending treatment in another
- •investigational device or drug study. Other investigational procedures while participating in this study are excluded.
- •o Exception to this criterion is the participation in Study 20130354 and all procedures related to this study.
- •Treatment with any chemotherapy, radiotherapy, immunotherapy, biologic, or hormonal therapy for cancer within 14 days prior to study entry or not
- •recovered from treatment
- •unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE), version
- •4.0 grade 1 or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from anti-tumor therapy that are considered
- •irreversible (defined as having been present and stable for > 6 months), may be allowed if they are not otherwise described in the exclusion criteria AND
- •there is agreement to allow by both the investigator and the sponsor
- •Recent history of cardiac disease, including myocardial infarction, unstable angina pectoris, or uncontrolled arrhythmia within 6 months; or evidence of
- •severe congestive heart failure with New York Heart Association severity classification > Class I within 12 weeks prior to screening
- •History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above), that in the opinion of
- •the investigator or sponsor would pose a risk to subject’s safety or interfere with the study evaluation, procedures, or completion
- •Clinical history of significant central nervous system (CNS) pathology (including but not limited to: history of brain metastasis, multiple occu
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