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

ABSTRACT:

Background

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).

Methods

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.

Results

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 sk

SUBMITTER: Strumberg D 

PROVIDER: S-EPMC3364125 | biostudies-literature | 2012 May

REPOSITORIES: biostudies-literature