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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001988-52 | EudraCT Number |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The study will primarily assess the antitumor activity of crizotinib in a variety of tumors with alterations in ALK and/or MET pathways. The targeted patient population will include patients with tumors harboring specific alterations leading to ALK and/or MET activation, where tyrosine kinase inhibitors against these targets have not yet been adequately explored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crizotinib in Anaplastic large cell lymphoma | Experimental |
| |
| Crizotinib in Inflammatory myofibroblastic tumor | Experimental |
| |
| Crizotinib in Papillary renal cell carcinoma type 1 | Experimental |
| |
| Crizotinib in Clear cell sarcoma | Experimental |
| |
| Crizotinib in Alveolar soft part sarcoma | Experimental |
| |
| Crizotinib in Alveolar rhabdomyosarcoma | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crizotinib (PF-02341066) | Drug | For patients of 15yo and older, Capsules of 200 and 250 mg Daily dose of 500, 400 or 250 mg/day depending on toxicitie; for patients younger than 15yo, 280 mg/m²/dose BID, with reductions allowed to 80% as first reduction and to 60% as second reduction respectively of the initial dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Antitumor activity of crizotinib | To study the antitumor activity of crizotinib across predefined tumor types in patients whose tumors are harboring specific alterations in ALK and/or MET |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (reporting of adverse events according to CTCAE v4.0) | ||
| Progression free survival | ||
| Disease control rate |
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General inclusion criteria:
Disease-specific inclusion criteria for patients with anaplastic large cell lymphoma
Disease-specific inclusion criteria for patients with inflammatory myofibroblastic tumor
Disease-specific inclusion criteria for patients with papillary renal cell carcinoma type 1
Disease-specific inclusion criteria for patients with clear cell sarcoma
Disease-specific inclusion criteria for patients with alveolar soft part sarcoma
Disease-specific inclusion criteria for patients with alveolar rhabdomyosarcoma
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires Bordet-Erasme - Institut Jules Bordet | Brussels | Belgium | ||||
| U.Z. Gasthuisberg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34392187 | Derived | Schoffski P, Kubickova M, Wozniak A, Blay JY, Strauss SJ, Stacchiotti S, Switaj T, Bucklein V, Leahy MG, Italiano A, Isambert N, Debiec-Rychter M, Sciot R, Lee CJ, Speetjens FM, Nzokirantevye A, Neven A, Kasper B. Long-term efficacy update of crizotinib in patients with advanced, inoperable inflammatory myofibroblastic tumour from EORTC trial 90101 CREATE. Eur J Cancer. 2021 Oct;156:12-23. doi: 10.1016/j.ejca.2021.07.016. Epub 2021 Aug 13. | |
| 29669701 |
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|
| Overall survival |
| Duration of response |
| Correlative research endpoints |
| Leuven |
| Belgium |
| Institut Bergonie | Bordeaux | France |
| Centre Georges-Francois-Leclerc | Dijon | France |
| Centre Leon Berard | Lyon | France |
| Assistance Publique - Hôpitaux de Marseille - Hôpital de La Timone | Marseille | France |
| Institut Gustave Roussy | Villejuif | France |
| Helios Klinikum Bad Saarow | Bad Saarow | Germany |
| Universitaetsklinikum Carl Gustav Carus | Dresden | Germany |
| Universitaetsklinikum - Essen | Essen | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| UniversitaetsMedizin Mannheim | Mannheim | Germany |
| Klinikum Grosshadern Ludwig-Maximilians Univ. Muenchen | München | Germany |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Italy |
| Leiden University Medical Centre | Leiden | Netherlands |
| Radboud University Nijmegen Medical Centre | Nijmegen | Netherlands |
| Erasmus MC - Sophia kindersiekenhuis | Rotterdam | Netherlands |
| Oslo University Hospital - Radiumhospitalet | Oslo | Norway |
| Maria Sklodowska-Curie Memorial Cancer Centre | Warsaw | Poland |
| National Cancer Institute | Bratislava | Slovakia |
| The Institute Of Oncology | Ljubljana | Slovenia |
| St. James's University Hospital | Leeds | United Kingdom |
| University College Hospital | London | United Kingdom |
| Christie NHS Foundation Trust | Manchester | United Kingdom |
| Nottingham University Hospitals NHS Trust - City Hospital | Nottingham | United Kingdom |
| Derived |
| Schoffski P, Sufliarsky J, Gelderblom H, Blay JY, Strauss SJ, Stacchiotti S, Rutkowski P, Lindner LH, Leahy MG, Italiano A, Isambert N, Debiec-Rychter M, Sciot R, Van Cann T, Marreaud S, Nzokirantevye A, Collette S, Wozniak A. Crizotinib in patients with advanced, inoperable inflammatory myofibroblastic tumours with and without anaplastic lymphoma kinase gene alterations (European Organisation for Research and Treatment of Cancer 90101 CREATE): a multicentre, single-drug, prospective, non-randomised phase 2 trial. Lancet Respir Med. 2018 Jun;6(6):431-441. doi: 10.1016/S2213-2600(18)30116-4. Epub 2018 Apr 15. |
| 29567632 | Derived | Schoffski P, Wozniak A, Leahy MG, Aamdal S, Rutkowski P, Bauer S, Richter S, Grunwald V, Debiec-Rychter M, Sciot R, Geoerger B, Marreaud S, Collette S, Nzokirantevye A, Strauss SJ. The tyrosine kinase inhibitor crizotinib does not have clinically meaningful activity in heavily pre-treated patients with advanced alveolar rhabdomyosarcoma with FOXO rearrangement: European Organisation for Research and Treatment of Cancer phase 2 trial 90101 'CREATE'. Eur J Cancer. 2018 May;94:156-167. doi: 10.1016/j.ejca.2018.02.011. Epub 2018 Mar 20. |
| 29216400 | Derived | Schoffski P, Wozniak A, Kasper B, Aamdal S, Leahy MG, Rutkowski P, Bauer S, Gelderblom H, Italiano A, Lindner LH, Hennig I, Strauss S, Zakotnik B, Anthoney A, Albiges L, Blay JY, Reichardt P, Sufliarsky J, van der Graaf WTA, Debiec-Rychter M, Sciot R, Van Cann T, Marreaud S, Raveloarivahy T, Collette S, Stacchiotti S. Activity and safety of crizotinib in patients with alveolar soft part sarcoma with rearrangement of TFE3: European Organization for Research and Treatment of Cancer (EORTC) phase II trial 90101 'CREATE'. Ann Oncol. 2018 Mar 1;29(3):758-765. doi: 10.1093/annonc/mdx774. |
| 28950372 | Derived | Schoffski P, Wozniak A, Stacchiotti S, Rutkowski P, Blay JY, Lindner LH, Strauss SJ, Anthoney A, Duffaud F, Richter S, Grunwald V, Leahy MG, Reichardt P, Sufliarsky J, van der Graaf WT, Sciot R, Debiec-Rychter M, van Cann T, Marreaud S, Lia M, Raveloarivahy T, Collette L, Bauer S. Activity and safety of crizotinib in patients with advanced clear-cell sarcoma with MET alterations: European Organization for Research and Treatment of Cancer phase II trial 90101 'CREATE'. Ann Oncol. 2017 Dec 1;28(12):3000-3008. doi: 10.1093/annonc/mdx527. |
| ID | Term |
|---|---|
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| D006104 | Granuloma, Plasma Cell |
| D018234 | Sarcoma, Alveolar Soft Part |
| D018227 | Sarcoma, Clear Cell |
| D018232 | Rhabdomyosarcoma, Alveolar |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006099 | Granuloma |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |
| D009372 | Neoplasms, Connective Tissue |
| D012208 | Rhabdomyosarcoma |
| D009217 | Myosarcoma |
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| ID | Term |
|---|---|
| D000077547 | Crizotinib |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
| D011725 | Pyridines |
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