Relapsed/refractory gastrointestinal adenocarcinoma
Conditions
Interventions
Product Name: 89Zr-AMG211
Product Code: 89Zr-AMG211
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AMG 211
Current Spo
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 50 mL/min calculated by Cockroft-Gault o Lipase/amylase =65 years) yes F.1.3.1 Number of subjects for this age range 35
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this imaging study is to evaluate the in vivo biodistribution (measured in SUV (Standard Uptake Values)) and quantitative radioactivity in organs of 89Zr-AMG211 in patients with relapsed/refractory gastrointestinal adenocarcinoma as assessed by PET/CT. o To evaluate the accumulation, distribution and localization of 89Zr-AMG211 in tumor tissue, organs and blood. ; Secondary Objective: The secondary objectives of this imaging study are: • To evaluate the correlation between 89Zr-AMG211 tumor uptake and response to therapy. • Number of patients with adverse events after 89Zr-AMG211 injection as a measure of safety and tolerability. ; Primary end point(s): • The quantitative uptake of 89Zr-AMG211 in tumor tissue, organs and blood circulation expressed in SUV (Standardized Uptake Value) 89Zr-AMG211 tumor uptake and organ distribution will be scored visually and quantitatively. Standardized uptake value (SUV), relative uptake value (RUV) and %ID (percentage of injected dose) of 89Zr will be determined in the tumor lesions and in relevant tissues. These calculations will provide information on 89Zr-AMG211 penetration in gastrointestinal adenocarcinoma and the organ distribution. ;Timepoint(s) of evaluation of this end point: During the study we will continously monitor the obtained results. To evaluate the primary endpoint all data will be analysed when the study is ended. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Response to AMG 211 therapy will be analyzed in Study 20130354 according to the immune related response criteria (irRC). These results will be correlated to 89Zr-AMG211 tumor uptake data (measured in SUV). • Number of patients with adverse events after 89Zr-AMG211 injection as a measure of safety and tolerability. Incidence, nature and severity of adverse events will be measured. ; Timepoint(s) of evaluation of this end point: This will be analysed when the end of study is reached. | — |
Countries
Netherlands
Contacts
Public ContactE.G.E. de Vries
University Medical Center Groningen
Outcome results
None listed