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Clinical trials in Europe PowerPoint Presentation

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Description : Check out this medical presentation on Drug Development, which is titled "Clinical trials in Europe", to know about Clinical Trials in Europe.

Tags : Drug Development, Clinical trials, Europe

Published on : Jul 20, 2021 | Views : 1856 | Downloads : 0

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Professor Bruce Morland Birmingham, UK Clinical trials in Europe
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Change of Paradigm in Oncology Drug Development& Era of High-throughput Technologies- When Biology Meets Clinics ….. ~ 1000 Anticancer compounds yearly under development Targeted anticancer compounds New mechanisms of action New profile of activity Distinct profile of toxicity Oral and prolonged administration
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SMO inhibition in Pediatric Patients Geoerger et al. ASCO 2012
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BRAFv600 inhibition in Pediatric Patients Primary Tumor Type Treatment Duration (Weeks) Kieran et al. ASCO 2015 HGG PTC NB LGG LCH ORR: HGG 5/8 63% anaplastic astrocytoma, glioma, ganglioglioma, pleomorphic xanthoastrocytoma, gliobastoma multiforme LGG 5/15 33% Ganglioglioma, pilocytic astrocytoma, pilomyxoid astrocytoma, pleomorphic xanthoastrocytoma LCH 2/2 100% Other 0% 20 of 27 patients remain on dabrafenib at data cut 7 March 2015
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Geoerger et al. ASCO 2015 ALK inhibition in ALK+ IMT or ALCL
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Hallmarks of Cancer
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Children small adults? Vogelstein et al., Science 2013 ≠
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Pediatric cancers are (relatively) simple … Courtesy of Stefan Pfister
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Discrepancies between primary and relapse Courtesy of Stefan Pfister
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MAPPYACTS (France, Spain, Italy, Ireland, Israel) 1. Generate invididual molecular information MATCH 2. Match treatment and tumor profile SHARE EU Clinico Biological (WES/RNAseq Data Base Project A Project B Project C Project D Project E 4. Generate new knowledge, new druggable pathways INFORM (Germany) iTHER (The Netherlands) SM-PAEDs (UK) Molecular Matching Trials Pediatric New Drug Development ESMART trial Multiarm Phase 1 Trials (Industry and ISTs) Phase 2 Trials (Industry and ISTs) 3. Evaluate activity of drugs and combinations Genentech Roche Matrix Trial Precision Medicine Program in ITCC INFORM2 trial series
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Drug availability is currently not a criterium in the pediatric setting (otherwise almost all targets would get a low score) Target prioritization – how to translate “gut feeling“ into a score!?
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MAPPYACTS (France, Spain, Italy, Ireland, Israel) 1. Generate invididual molecular information MATCH 2. Match treatment and tumor profile SHARE EU Clinico Biological (WES/RNAseq Data Base Project A Project B Project C Project D Project E 4. Generate new knowledge, new druggable pathways INFORM (Germany) iTHER (The Netherlands) SM-PAEDs (UK) Molecular Matching Trials Pediatric New Drug Development ESMART trial Multiarm Phase 1 Trials (Industry and ISTs) Phase 2 Trials (Industry and ISTs) 3. Evaluate activity of drugs and combinations Genentech Roche Matrix Trial Precision Medicine Program in ITCC INFORM2 trial series
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Ewing, rhabdo, neuroblastoma, Wilms, hepatoblastoma on backbone of temozolomide /irinotecan
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74 patients (median age 14 years; range 2–29) were enrolled: osteosarcoma, n = 12; Ewing sarcoma, n = 11; neuroblastoma, n = 11; rhabdomyosarcoma (RMS), n = 10; non-RMS soft tissue sarcoma, n = 10; Wilms tumor, n = 6; Hodgkin lymphoma (HL), n = 5; non-HL, n = 1; other tumor types, n = 8 17 patients (24%) had treatment-related grade 3–4 AEs. One AE (grade 3 transaminase increase) led to study drug discontinuation. Common AEs were pyrexia (37%), fatigue (34%) and constipation (32%) 2/5 patients with HL had a partial response (PR); the only patient with atypical rhabdoid tumor (RT) had an unconfirmed PR Ongoing with rhabdoid/ATRT A phase I/II study of atezolizumab in pediatric and young adult patients with refractory/relapsed solid tumors (iMATRIX-Atezolizumab). Geoerger et al. J Clin Oncol 35, 2017 (suppl; abstr 10524)
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Conclusions ITCC is a successful academic partnership Biology-led/precision medicine programme is deliverable Partnership/collaboration with Pharma is key Joint discussion with clinicians, regulators, pharma and parent groups, Accelerate has proven very successful (www.accelerate-platform.eu) Portfolio expanding
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