Regorafenib (BAY 73-4506) in advanced colorectal cancer: a phase I study.

British Journal of Cancer
D StrumbergK Mross

Abstract

In a phase I dose-escalation study, regorafenib demonstrated tolerability and antitumour activity in solid tumour patients. The study was expanded to focus on patients with metastatic colorectal cancer (CRC). Patients received oral regorafenib 60-220 mg daily (160 mg daily in the extension cohort) in cycles of 21 days on, 7 days off treatment. Assessments included toxicity, response, pharmacokinetics and pharmacodynamics. Thirty-eight patients with heavily pretreated CRC (median 4 prior lines of therapy, range 0-7) were enrolled in the dose-escalation and extension phases; 26 patients received regorafenib 160 mg daily. Median treatment duration was 53 days (range 7-280 days). The most common treatment-related toxicities included hand-foot skin reaction, fatigue, voice change and rash. Twenty-seven patients were evaluable for response: 1 achieved partial response and 19 had stable disease. Median progression-free survival was 107 days (95% CI, 66-161). At steady state, regorafenib and its active metabolites had similar systemic exposure. Pharmacodynamic assessment indicated decreased tumour perfusion in most patients. Regorafenib showed tolerability and antitumour activity in patients with metastatic CRC. This expanded-cohort ph...Continue Reading

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Dec 4, 2013·Future Oncology·Raj Kumar Shukla
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Methods Mentioned

BETA
xenograft
biopsies

Clinical Trials Mentioned

NCT01103323

Software Mentioned

WinNonlin
OncoCarta

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