Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma (HCC) Treated After Transcatheter Arterial Chemoembolization (TACE)

NCT00494299 ↗

Phase 3 Completed 458 enrolled Bayer

RandomizedParallel-groupTriple-blindTreatment

Summary

Clinical trial of BAY43-9006 in patients with hepatocellular carcinoma.

Timeline

Start: 2006-04
Primary completion: 2009-07
Completion: 2010-11

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Sorafenib (Nexavar, BAY43-9006) vs Placebo; Log Rank 0.25204620 NCT00494299 ↗

paper This trial, conducted prior to the reporting of registrational phase III trials, found that sorafenib did not significantly prolong TTP PMID 21664811 ↗

Publications

Results Kudo M, Imanaka K, Chida N, Nakachi K, Tak WY, Takayama T, Yoon JH, Hori T, Kumada H, Hayashi N, Kaneko S, Tsubouchi H, Suh DJ, Furuse J, Okusaka T, Tanaka K, Matsui O, Wada M, Yamaguchi I, Ohya T, Meinhardt G, Okita K. Phase III study of sorafenib after transarterial chemoembolisation in Japanese and Korean patients with unresectable hepatocellular carcinoma. Eur J Cancer. 2011 Sep;47(14):2117-27. doi: 10.1016/j.ejca.2011.05.007.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sorafenib	Small molecule	400 mg	Oral