89Zr-AMG211 PET Imaging Study
Palabras clave
Abstracto
fechas
| Verificado por última vez: | 05/31/2017 |
| Primero enviado: | 03/14/2016 |
| Inscripción estimada enviada: | 04/27/2016 |
| Publicado por primera vez: | 05/02/2016 |
| Última actualización enviada: | 05/31/2017 |
| Última actualización publicada: | 06/01/2017 |
| Fecha de inicio real del estudio: | 07/31/2016 |
| Fecha estimada de finalización primaria: | 05/02/2017 |
| Fecha estimada de finalización del estudio: | 05/02/2017 |
Condición o enfermedad
Intervención / tratamiento
Drug: 89Zr-AMG211 and 89Zr-AMG211 PET
Device: 89Zr-AMG211 and 89Zr-AMG211 PET
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Experimental: 89Zr-AMG211 and 89Zr-AMG211 PET | Drug: 89Zr-AMG211 and 89Zr-AMG211 PET Injection of 89Zr-AMG211 for imaging. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - Subject will or is also participating in the ongoing phase 1 study in which AMG 211 is administered via cIV. 89Zr-AMG211 PET imaging will be performed before and/or during treatment with AMG 211 cIV - Informed consent provided - Male or Female ≥ 18 years of age at the time of informed consent - Advanced relapsed/refractory gastrointestinal adenocarcinoma - At least 1 measurable tumor lesion o In case the investigators 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 - Body weight ≥ 45 kg - Other inclusion criteria may apply Exclusion Criteria: - Malignancy other than GI adenocarcinoma requiring current therapy - Evidence of uncontrolled systemic disease (other than GI adenocarcinoma), active infection, Hepatitis B and/or C, HIV, history of cardiac disease, history of significant central nervous system (CNS) disease, history of chronic autoimmune disease (with the exception of stable type 1 diabetes) - Major surgery within 28 days of study day 1 - 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 the currently ongoing phase 1 study with AMG 211 cIV 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 - Males or Females of reproductive potential and unwilling to practice an acceptable method of effective birth control while on study through 30 days after receiving the last dose of study drug. - Females who are pregnant, planning to become pregnant, lactating/breastfeeding or who plan to breastfeed while on study through 30 days after receiving the last dose of study drug - Other exclusion criteria may apply |
Salir
Medidas de resultado primarias
1. The quantitative uptake op 89Zr-AMG211 in tumor tissue, organs and blood circulation expressed in SUV (Standardized Uptake Value) [1 year]
Medidas de resultado secundarias
1. Response to AMG 211 therapy according to the immune related response criteria (irRC) will be correlated to 89Zr-AMG211 tumor uptake data (measured in SUV). [1 year]
2. Number of patients with adverse events after 89Zr-AMG211 injection as a measure of safety and tolerability. Incidence, nature and severity of adverse events (according to CTCAE version 4.03) will be measured. [1 year]
Otras medidas de resultado
1. Explore the target tissue saturation by AMG 211, defined as changes in tissue uptake of radioactivity concentration, and correlate it with pharmacokinetics. [1 year]
2. Evaluate 89Zr-AMG211 as a complementary tool for improved patient selection for targeted therapy with AMG 211. [1 year]
