CREATE: Cross-tumoral Phase 2 With Crizotinib

Summary

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.

Timeline

Start

2012-09

Primary completion

2017-12-06

Completion

2022-10-30

Outcome

Mixed primary results

paper With 50% of participants with ALK-positive tumours achieving an objective response, crizotinib met the prespecified criteria for success in this trial. PMID 29669701 ↗

paper Crizotinib is well toleratedbut lacks clinically meaningful activity as a single agent in patients with advanced metastatic ARMS. PMID 29567632 ↗

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications