Regorafenib in advanced colorectal cancer: a phase I study
British Journal of Cancer, 05/10/2012
Strumberg D et al. – Regorafenib showed tolerability and antitumour activity in patients with metastatic colorectal cancer (CRC). This expanded–cohort phase I study provided the foundation for further clinical trials of regorafenib in this patient population.
Patients received oral regorafenib 60–220mg daily (160mg daily in the extension cohort) in cycles of 21days on, 7days 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 160mg daily.
Median treatment duration was 53days (range 7–280days).
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 107days (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.
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