Population pharmacokinetics, exposure-safety, and immunogenicity of atezolizumab in pediatric and young adult patients with cancer.
| Title: | Population pharmacokinetics, exposure-safety, and immunogenicity of atezolizumab in pediatric and young adult patients with cancer. |
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| Authors: | Shemesh CS; Department of Clinical Pharmacology Oncology, Genentech Inc., South San Francisco, CA, 94080, USA. shemesh.colby@gene.com.; Chanu P; Clinical Pharmacology, Modeling and Simulation, Genentech/Roche, Marseille, France.; Jamsen K; Certara Strategic Consulting, Princeton, NJ, USA.; Wada R; Certara Strategic Consulting, Princeton, NJ, USA.; Rossato G; Clinical Science, F. Hoffmann-La Roche Ltd, Basel, Switzerland.; Donaldson F; Safety Science, Roche Products Ltd, Welwyn Garden City, UK.; Garg A; Department of Clinical Pharmacology Oncology, Genentech Inc., South San Francisco, CA, 94080, USA.; Present address: Quantitative Pharmacology and Disposition, Seattle Genetics, South San Francisco, CA, USA.; Winter H; Department of Clinical Pharmacology Oncology, Genentech Inc., South San Francisco, CA, 94080, USA.; Present address: Quantitative Pharmacology and Disposition, Seattle Genetics, South San Francisco, CA, USA.; Ruppel J; Bioanalytical Sciences, Genentech Inc., South San Francisco, CA, USA.; Wang X; Department of Clinical Pharmacology Oncology, Genentech Inc., South San Francisco, CA, 94080, USA.; Bruno R; Clinical Pharmacology, Modeling and Simulation, Genentech/Roche, Marseille, France.; Jin J; Department of Clinical Pharmacology Oncology, Genentech Inc., South San Francisco, CA, 94080, USA.; Girish S; Department of Clinical Pharmacology Oncology, Genentech Inc., South San Francisco, CA, 94080, USA. |
| Source: | Journal for immunotherapy of cancer [J Immunother Cancer] 2019 Nov 21; Vol. 7 (1), pp. 314. Date of Electronic Publication: 2019 Nov 21. |
| Publication Type: | Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't |
| Language: | English |
| Journal Info: | Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101620585 Publication Model: Electronic Cited Medium: Internet ISSN: 2051-1426 (Electronic) Linking ISSN: 20511426 NLM ISO Abbreviation: J Immunother Cancer Subsets: MEDLINE |
| Imprint Name(s): | Publication: 2020- : London, United Kingdom : BMJ Publishing Group Ltd.; Original Publication: London : BioMed Central, 2013- |
| MeSH Terms: | Antibodies, Monoclonal, Humanized/*pharmacokinetics ; Antineoplastic Agents/*pharmacokinetics ; Neoplasms/*metabolism; Antibodies, Monoclonal, Humanized/adverse effects ; Antibodies, Monoclonal, Humanized/blood ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/blood ; Antineoplastic Agents/therapeutic use ; Neoplasms/drug therapy ; Neoplasms/immunology ; Neoplasms/mortality ; Adolescent ; Adult ; Child ; Child, Preschool ; Female ; Humans ; Infant ; Male ; Models, Biological ; Progression-Free Survival ; Treatment Outcome ; Young Adult |
| Abstract: | Background: The iMATRIX-atezolizumab study was a phase I/II, multicenter, open-label study designed to assess the safety and pharmacokinetics of atezolizumab in pediatric and young adult patients. We describe the pharmacokinetics (PK), exposure-safety, and immunogenicity of atezolizumab in pediatric and young adults with metastatic solid tumors or hematologic malignancies enrolled in this study.; Methods: Patients aged |
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| Contributed Indexing: | Keywords: Atezolizumab; Cancer immunotherapy; Clinical pharmacology; Exposure-safety; Immune checkpoint inhibitor; Pediatric oncology; Population pharmacokinetics |
| Molecular Sequence: | ClinicalTrials.gov NCT02541604 |
| Substance Nomenclature: | 0 (Antibodies, Monoclonal, Humanized); 0 (Antineoplastic Agents); 52CMI0WC3Y (atezolizumab) |
| Entry Date(s): | Date Created: 20191123 Date Completed: 20200702 Latest Revision: 20240722 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC6868826 |
| DOI: | 10.1186/s40425-019-0791-x |
| PMID: | 31753029 |
| Database: | MEDLINE |
Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't