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Soluble in DMSO. Regorafenib demonstrated tolerability and antitumour activity in patients with metastatic colorectal cancer (CRC) in a phase 1 clinical trail. Strumberg D., et al. 'Regorafenib (BAY 73-4506) in advanced colorectal cancer: a phase I study.' Br. J. Cancer 106: 1722-1727 (2012). In combination chemotherapy, regorafenib showed acceptable tolerability with SN-38 and irinotecan but showed no significant effect on oxaliplatin or 5-fluorouracil pharmacokinetics. Schultheis B., et al. 'Regorafenib in combination with FOLFOX or FOLFIRI as first- or second-line treatment of colorectal cancer: results of a multicenter, phase Ib study.' Ann. Oncol. 24: 1560-1567 (2013). Regorafenib showed significant activity in patients with advanced and metastatic GI stromal tumor (GIST) after failure of both imatinib and sunitinib in a phase 2 clinical trial. George S., et al. 'Efficacy and safety of regorafenib in patients with metastatic and/or unresectable GI stromal tumor after failure of imatinib and sunitinib: a multicenter phase II trial.' J. Clin. Oncol. 30: 2401-2407 (2012). In a phase 2 clinical trial, regorafenib demonstrated acceptable tolerability and antitumour activity in patients with intermediate or advanced hepatocellular carcinoma (HCC) after failure of first-line sorafenib. Bruix J., et al. 'Regorafenib as second-line therapy for intermediate or advanced hepatocellular carcinoma: Multicentre, open-label, phase II safety study.' Eur. J. Cancer 49: 3412-3419 (2013). In a phase 3 study, regorafenib demonstrated prolonged survival of patients with metastatic colorectal cancer after standard therapies failed. Grothey A., et al. 'Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial.' Lancet 381: 303-312 (2013). Regorafenib demonstrated antitumour activity as a first-line treatment for metastatic or unresectable renal-cell carcinoma in a phase 2 clinical trial. However, the drug's safety profile required close monitoring. Eisen T., et al. 'Regorafenib for patients with previously untreated metastatic or unresectable renal-cell carcinoma: a single-group phase 2 trial.' Lancet Oncol. 13: 1055-1062 (2012). Oral regorafenib significantly improved progression-free survival when compared with placebo in patients with metastatic gastrointestinal stromal tumours (GIST) after failure of standard treatments in a phase 3 clinical trial. Demetri G.D., et al. 'Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo-controlled, phase 3 trial.' Lancet 381: 295-302 (2013).
This website uses cookies, which are necessary for the technical operation of the website and are always set. Other cookies, which increase the usability of this website, serve for direct advertising or simplify interaction with other websites and social networks, will only be used with your consent.
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