Reuters Health Information (2013-09-03): Safety committee raises concern over tivantinib for liver cancer
Safety committee raises concern over tivantinib for liver cancer
Last Updated: 2013-09-03 13:40:23 -0400 (Reuters Health)
(Reuters) - Drugmaker ArQule Inc said a late-stage trial of its liver cancer drug tivantinib showed high incidence of leukopenia in patients, leading to an independent safety committee recommending the company lower the drug dose.
The Data Monitoring Committee recommended that the study dose be reduced from 240 mg twice daily to 120 mg, and the patients be monitored to confirm the safety profile of the lower dose.
ArQule and its partner Daiichi Sankyo Inc accepted the recommendation of the committee and will file a protocol amendment with regulatory authorities, ArQule said in a regulatory filing.
Tivantinib is an orally bioavailable small molecule inhibitor of c-Met with potential antineoplastic activity. The companies were testing tivantinib as a treatment for hepatocellular cancer, the most common type of liver cancer.
The companies said they were unable to comment on whether the timeline for recruitment of the trial might be delayed from original estimates as a result of the proposed change and the subsequent data review, as the study was in the early stages of recruitment.