89Zr-AMG211 PET imaging in patients with relapsed/refractory gastrointestinal adenocarcinoma before and during treatment with AMG 211

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

•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
effective
•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

Exclusion Criteria

• 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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