How Can Radiopharmaceutical Therapies Reach Their Full Potential? Improving Dose Reporting and Phase I Clinical Trial Design: Improving Dose Reporting and Phase I Clinical Trial Design

Συγγραφείς: Ana P. Kiess, Joseph O'Donoghue, Carlos Uribe, Lisa Bodei, Robert F. Hobbs, Jacob Hesterman, Adam L. Kesner, George Sgouros, Tom Bäck, Manuel Bardies, Alessandro Bartolini, Sören Bentzen, Peter Bernhardt, Ingrid Bloise, Wesley Bolch, Patrik Brodin, Julia Brosch-Lenz, Jacek Capala, Carlo Chiesa, Patricia E. Cole, Marta Cremonesi, Emmanuel Deshayes, Yuni Dewaraja, Roberto Formento-Cavaier, Gerhard Glatting, Harwig Hennekes, Rob Hobbs, Vicki Jardine, Jessica Jensen, Adam Kesner, Mark W. Konijnenberg, Clemens Kratochwil, Phillip H. Kuo, Roberto Maass-Moreno, Michael Morris, Quyen Nguyen, Stig Palm, Neeta Pandit-Taskar, Laurens Raes, Hendrik Rathke, Babak Saboury, Nicola Salem, Lore Santoro, Oliver Sartor, Mike Sathekge, Eileen Sneeden, Lidia Strigari, Scott Tagawa, Amanda Walker, Wolfgang Weber, Fred Wilson, Tahir Yusufaly, Sabine Zitzmann-Kolbe

Συνεισφορές: Supporting clinical sciences, Molecular Imaging and Therapy, Faculty of Medicine and Pharmacy, Nuclear Medicine

Πηγή: Journal of Clinical Oncology. 42:1734-1737

Θεματικοί όροι: Clinical Trials, Phase I as Topic, Research Design, Neoplasms, Clinical Trials, Phase I as Topic/methods, Humans, Radiopharmaceuticals, Neoplasms/radiotherapy, Radiopharmaceuticals/therapeutic use

Σύνδεσμος πρόσβασης: https://pubmed.ncbi.nlm.nih.gov/38484205
https://biblio.vub.ac.be/vubir/(5ffbaabb-f528-46c5-a90a-4e71782c3e9d).html

Ultra-sensitive LC–MS/MS method for the quantification of gemcitabine and its metabolite 2′,2′-difluorodeoxyuridine in human plasma for a microdose clinical trial

Συγγραφείς: Jos H. Beijnen, Michel J.X. Hillebrand, Hilde Rosing, Jan H.M. Schellens, M. van Nuland, Jacobus A. Burgers

Συνεισφορές: Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology

Πηγή: Journal of Pharmaceutical and Biomedical Analysis. 151:25-31

Θεματικοί όροι: Chromatography, Phase I as Topic/methods, Clinical Trials, Phase I as Topic, Chromatography, Liquid/methods, Clinical Trials, Phase I as Topic/methods, Reproducibility of Results, Floxuridine/analogs & derivatives, Tandem Mass Spectrometry/methods, Deoxycytidine, Gemcitabine, 01 natural sciences, 0104 chemical sciences, 3. Good health, 03 medical and health sciences, Deoxycytidine/analogs & derivatives, 0302 clinical medicine, Tandem Mass Spectrometry, Liquid/methods, Taverne, Humans, Clinical Trials, Floxuridine, Chromatography, Liquid

Περιγραφή αρχείου: application/pdf

Σύνδεσμος πρόσβασης: https://pubmed.ncbi.nlm.nih.gov/29294409
https://research-portal.uu.nl/en/publications/efc4596d-1307-4e65-9570-9a9113d7ecf1
https://doi.org/10.1016/j.jpba.2017.12.048
https://pubmed.ncbi.nlm.nih.gov/29294409/
https://www.ncbi.nlm.nih.gov/pubmed/29294409
https://europepmc.org/abstract/MED/29294409
https://www.narcis.nl/publication/RecordID/oai%3Adspace.library.uu.nl%3A1874%2F376780
https://www.sciencedirect.com/science/article/pii/S0731708517326043
https://dspace.library.uu.nl/handle/1874/376780
https://dspace.library.uu.nl/handle/1874/376780

Baseline lymphopenia should not be used as exclusion criteria in early clinical trials investigating immune checkpoint blockers (PD-1/PD-L1 inhibitors)

Συγγραφείς: Roger Sun, Stéphane Champiat, Laurent Dercle, Sandrine Aspeslagh, Eduardo Castanon, Elaine Johanna Limkin, Capucine Baldini, Sophie Postel-Vinay, Antoine Hollebecque, Christophe Massard, Samy Ammari, Eric Deutsch, Jean-Charles Soria, Aurélien Marabelle, Charles Ferté

Συνεισφορές: Medical Oncology

Πηγή: European Journal of Cancer. 84:202-211

Θεματικοί όροι: Male, Programmed Cell Death 1 Receptor, B7-H1 Antigen/antagonists & inhibitors, Clinical Trials, Phase I as Topic/methods, Antineoplastic Agents, Kaplan-Meier Estimate, B7-H1 Antigen, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Lymphopenia, Neoplasms, Odds Ratio, risk factors, Humans, Lymphocyte Count, Molecular Targeted Therapy, Proportional Hazards Models, Lymphopenia/diagnosis, Clinical Trials, Phase I as Topic, Patient Selection, Programmed Cell Death 1 Receptor/antagonists & inhibitors, Antineoplastic Agents/adverse effects, Middle Aged, Neoplasms/drug therapy, 3. Good health, multivariate analysis, Treatment Outcome, Logistic Models, Multivariate Analysis, Immunotherapy/methods, Female, Immunotherapy, Molecular Targeted Therapy/methods

Σύνδεσμος πρόσβασης: https://pubmed.ncbi.nlm.nih.gov/28826073
https://www.ncbi.nlm.nih.gov/pubmed/28826073
https://pubmed.ncbi.nlm.nih.gov/28826073/
http://www.sciencedirect.com/science/article/pii/S095980491731153X
https://www.sciencedirect.com/science/article/pii/S095980491731153X
http://europepmc.org/abstract/MED/28826073
https://researchportal.vub.be/en/publications/baseline-lymphopenia-should-not-be-used-as-exclusion-criteria-in-

Prospective validation of a prognostic score for patients in immunotherapy phase I trials: The Gustave Roussy Immune Score (GRIm-Score): The Gustave Roussy Immune Score (GRIm-Score)

Συγγραφείς: Bigot, Frédéric, Castanon, Eduardo, Baldini, Capucine, Hollebecque, Antoine, Carmona, Alberto, Postel-Vinay, Sophie, Angevin, Eric, Armand, Jean-Pierre, Ribrag, Vincent, Aspeslagh, Sandrine, Varga, Andrea, Bahleda, Rastislav, Menis, Jessica, Gazzah, Anas, Michot, Jean-Marie, Marabelle, Aurélien, Soria, Jean-Charles, Massard, Christophe

Συνεισφορές: Medical Oncology

Πηγή: European Journal of Cancer. 84:212-218

Θεματικοί όροι: Adult, Male, 0301 basic medicine, Developmental drugs, Immunotherapy, Phase I studies, Prognostic score, Aged, Aged, 80 and over, Biomarkers, Clinical Trials, Phase I as Topic, Female, Health Status, Humans, Kaplan-Meier Estimate, L-Lactate Dehydrogenase, Lymphocyte Count, Lymphocytes, Middle Aged, Multivariate Analysis, Neoplasms, Neutrophils, Predictive Value of Tests, Proportional Hazards Models, Prospective Studies, Reproducibility of Results, Retrospective Studies, Risk Factors, Serum Albumin, Serum Albumin, Human, Time Factors, Treatment Outcome, Young Adult, Health Status Indicators, Patient Selection, Oncology, Cancer Research, Clinical Trials, Phase I as Topic/methods, health status, Lymphocytes/immunology, 03 medical and health sciences, 0302 clinical medicine, risk factors, L-Lactate Dehydrogenase/blood, Serum Albumin/analysis, Neutrophils/immunology, 3. Good health, Immunotherapy/adverse effects, multivariate analysis, Neoplasms/blood, young adult, reproducibility of results, aged, 80 and over, Biomarkers/blood

Σύνδεσμος πρόσβασης: https://pubmed.ncbi.nlm.nih.gov/28826074
https://researchportal.vub.be/en/publications/prospective-validation-of-a-prognostic-score-for-patients-in-immu
https://www.ncbi.nlm.nih.gov/pubmed/28826074
https://pubmed.ncbi.nlm.nih.gov/28826074/
https://www.sciencedirect.com/science/article/abs/pii/S0959804917311474
http://www.sciencedirect.com/science/article/pii/S0959804917311474
https://europepmc.org/article/MED/28826074
http://www.journals.elsevier.com/european-journal-of-cancer/
https://doi.org/10.1016/j.ejca.2017.07.027
https://hdl.handle.net/11577/3290291
https://biblio.vub.ac.be/vubir/(bb3e7fa1-df02-4e58-918c-099ec0a157e2).html

Biases affecting injected doses of an experimental drug during clinical trials

Συγγραφείς: Nancy Perrottet, Françoise Brunner-Ferber, Eric Grouzmann, François Spertini, Jérôme Biollaz, Thierry Buclin, Nicolas Widmer

Πηγή: Trials
Trials, vol. 17, no. 1, pp. 321

Θεματικοί όροι: Clinical Trials, Phase I as Topic, Dose-Response Relationship, Drug, Research, Drug Compounding, Injections, Subcutaneous, Medicine (miscellaneous), Biological Availability, Drug Administration Schedule, 3. Good health, 03 medical and health sciences, 0302 clinical medicine, Bias, Research Design, Albumins, Injections, Intravenous, Albumins/metabolism, Biosimilar Pharmaceuticals/administration & dosage, Biosimilar Pharmaceuticals/chemistry, Biosimilar Pharmaceuticals/pharmacokinetics, Clinical Trials, Phase I as Topic/methods, Drug Dosage Calculations, Drug Labeling, Humans, Interferon beta-1a/administration & dosage, Interferon beta-1a/chemistry, Interferon beta-1a/pharmacokinetics, Protein Binding, Randomized Controlled Trials as Topic/methods, Clinical trials, Drug dose, Drug evaluation, Pharmacokinetics, Phase I as topic, Pharmacology (medical), Biosimilar Pharmaceuticals, Interferon beta-1a, Randomized Controlled Trials as Topic

Περιγραφή αρχείου: application/pdf

Σύνδεσμος πρόσβασης: https://trialsjournal.biomedcentral.com/track/pdf/10.1186/s13063-016-1463-5
https://pubmed.ncbi.nlm.nih.gov/27423899
https://serval.unil.ch/resource/serval:BIB_F4D76936AAE9.P001/REF.pdf
https://paperity.org/p/77573097/biases-affecting-injected-doses-of-an-experimental-drug-during-clinical-trials
https://www.ncbi.nlm.nih.gov/pubmed/27423899
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-016-1463-5
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4947517/
https://serval.unil.ch/notice/serval:BIB_F4D76936AAE9
https://serval.unil.ch/notice/serval:BIB_F4D76936AAE9
http://nbn-resolving.org/urn/resolver.pl?urn=urn:nbn:ch:serval-BIB_F4D76936AAE98
https://serval.unil.ch/resource/serval:BIB_F4D76936AAE9.P001/REF.pdf

Concomitant intraperitoneal and systemic chemotherapy for extensive peritoneal metastases of colorectal origin: protocol of the multicentre, open-label, phase I, dose-escalation INTERACT trial: Protocol of the multicentre, open-label, phase I, dose-escalation INTERACT trial

Συγγραφείς: Nadine Leonie de Boer, Alexandra R M Brandt-Kerkhof, Eva V E Madsen, Marjolein Diepeveen, Esther van Meerten, Ruben A G van Eerden, Femke M de Man, Rachida Bouamar, Stijn L W Koolen, Ignace H J T de Hingh, Checca Bakkers, Koen P Rovers, Geert-Jan M Creemers, Maarten J Deenen, Onno W Kranenburg, Alexander Constantinides, Ron H J Mathijssen, Cornelis Verhoef, Jacobus W A Burger

Συνεισφορές: CMM Groep Coffer, MS CGO, Regenerative Medicine and Stem Cells, Cancer

Πηγή: BMJ Open
BMJ Open, Vol 9, Iss 12 (2019)

Θεματικοί όροι: Organoplatinum Compounds, Leucovorin, Clinical Trials, Phase I as Topic/methods, colorectal cancer, intraperitoneal chemotherapy, Irinotecan, 03 medical and health sciences, 0302 clinical medicine, SDG 3 - Good Health and Well-being, Antineoplastic Combined Chemotherapy Protocols, Journal Article, systemic chemotherapy, Humans, Multicenter Studies as Topic, Infusions, Parenteral, Organoplatinum Compounds/administration & dosage, Peritoneal Neoplasms, Colorectal Neoplasms/pathology, Clinical Trials, Phase I as Topic, Research Support, Non-U.S. Gov't, palliative treatment, General Medicine, Peritoneal Neoplasms/drug therapy, Antineoplastic Combined Chemotherapy Protocols/administration & dosage, 3. Good health, dose-escalation study, peritoneal metastases, Fluorouracil/administration & dosage, EMC MM-03-86-08, Oncology, Research Design, Leucovorin/administration & dosage, EMC MM-03-47-11, Medicine, Irinotecan/administration & dosage, Fluorouracil, Colorectal Neoplasms, Multicenter Studies as Topic/methods

Περιγραφή αρχείου: image/pdf

Σύνδεσμος πρόσβασης: https://bmjopen.bmj.com/content/bmjopen/9/12/e034508.full.pdf
https://pubmed.ncbi.nlm.nih.gov/31818845
https://doaj.org/article/1ac30eab2d114a75841ee864e7752455
https://pure.eur.nl/en/publications/c1a7d195-eb1c-4dc8-8ca4-a18d20a2ed75
https://doi.org/10.1136/bmjopen-2019-034508
https://bmjopen.bmj.com/content/9/12/e034508
https://repub.eur.nl/pub/122754
https://www.ncbi.nlm.nih.gov/pubmed/31818845
https://www.narcis.nl/publication/RecordID/oai%3Adspace.library.uu.nl%3A1874%2F390345
https://repub.eur.nl/pub/122754/Repub_122754_O-A.pdf
https://bmjopen.bmj.com/content/bmjopen/9/12/e034508.full.pdf
https://dspace.library.uu.nl/handle/1874/390345

Challenges of phase 1 clinical trials evaluating immune checkpoint-targeted antibodies

Συγγραφείς: Postel-Vinay, S, Aspeslagh, S, Lanoy, E, Robert, C, Soria, J-C, Marabelle, A

Συνεισφορές: Medical Oncology, Faculty of Arts and Philosophy

Θεματικοί όροι: Maximum Tolerated Dose, Patient Selection, Antineoplastic Agents/therapeutic use, B7-H1 Antigen/antagonists & inhibitors, Dose-Response Relationship, Immunologic, Immunotherapy/methods, Clinical Trials, Phase I as Topic/methods, Humans, Drug Discovery/methods, Antibodies, Monoclonal/adverse effects, CTLA-4 Antigen/antagonists & inhibitors, Molecular Targeted Therapy/methods, Neoplasms/drug therapy

Σύνδεσμος πρόσβασης: https://biblio.vub.ac.be/vubir/challenges-of-phase-1-clinical-trials-evaluating-immune-checkpointtargeted-antibodies(f6c8ec87-0f5d-44c5-a45c-7393fda5a56f).html

Ultra-sensitive LC-MS/MS method for the quantification of gemcitabine and its metabolite 2',2'-difluorodeoxyuridine in human plasma for a microdose clinical trial

Συγγραφείς: van Nuland, M, Hillebrand, M J X, Rosing, H, Burgers, J A, Schellens, J H M, Beijnen, J H

Πηγή: Journal of Pharmaceutical and Biomedical Analysis vol.151 (2018) date: 2018-03-19 p.25-31 [ISSN 0731-7085]

Όροι ευρετηρίου: Chromatography, Liquid/methods, Clinical Trials, Phase I as Topic/methods, Deoxycytidine/analogs & derivatives, Floxuridine/analogs & derivatives, Humans, Reproducibility of Results, Tandem Mass Spectrometry/methods, Article

Σύνδεσμος: https://research-portal.uu.nl/en/publications/efc4596d-1307-4e65-9570-9a9113d7ecf1
https://dspace.library.uu.nl/bitstream/handle/1874/376780/Ultra.pdf?sequence=1
https://dspace.library.uu.nl/bitstream/handle/1874/376780/Ultra.pdf?sequence=1