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

Completed

Conditions: cholangio carcinoma
colon cancer
esophagus cancer
gastric cancer
pancreatic cancer
rectal cancer
10017991

Registration Number: NL-OMON43494

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

* Subject will be or is also participating in the ongoing phase 1 study 20130354 in which AMG 211 is administered via cIV. 89Zr-AMG211 PET imaging will be performed before and/or during treatment with AMG 211 cIV.
* 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
o In 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:
o Absolute neutrophil count (ANC) > 1500/mm3 (1.5 × 109/L)
o Platelet count > 100,000 mm3 (100 × 109/L)
o White blood cell (WBC) count > 3 × 109/L
o Hemoglobin > 9.0 g/dL
o AST and ALT < 3.0 × the upper limit of normal (ULN)
o Alkaline phosphatase (ALP) * 2.5 × ULN
o Total bilirubin (TBL) < 1.5 × ULN (unless subject has suspected Gilbert*s syndrome or extrahepatic cause by increased indirect bilirubin fraction)
o Creatinine clearance > 50 mL/min calculated by Cockroft-Gault
o Lipase/amylase < 1.5 x ULN
o Prothrombin 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

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 occurrences of confusion, dementia, previous CNS infarctions, migraine headaches [within 6 months prior to starting therapy with AMG 211], seizure disorder, or major brain surgery)
* History of chronic autoimmune disease, e.g., rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematosus, or multiple sclerosis (with the exception of stable type 1 diabetes)
* Males or Females o

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Quantitative uptake of 89Zr-AMG211 in tumor tissue, organs and blood by<br /><br>measuring standardized uptake value (SUV) on the 89Zr-AMG211 PET scans. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Response to AMG 211 therapy will be analyzed in Study 20130354 according to<br /><br>the immune related response criteria (irRC). These results will be correlated<br /><br>to 89Zr-AMG211 tumor uptake data (measured in SUV).<br /><br>* Number of patients with adverse events after 89Zr-AMG211 injection as a<br /><br>measure of safety and tolerability. Incidence, nature and severity of adverse<br /><br>events will be measured.</p><br>