|Study Of Sunitinib Malate Versus Sorafenib In Patients With Inoperable Liver Cancer|
|A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma|
|The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be given until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of study treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival.|
|This study was terminated on April 22th, 2010, based on a higher incidence of serious adverse events in the sunitinib arm compared to the sorafenib arm, and the fact that sunitinib did not meet the criteria to demonstrate that it was either superior or non-inferior to sorafenib in the survival of patients with advanced hepatocellular cancer. Patients on sunitinib who are judged by the investigator as receiving clinical benefit may chose to remain on study and continue treatment with sunitinib until clinical benefit as per the investigator's judgment.|
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
- Drug: sunitinib malate
sunitinib capsules at starting dose of 37.5 mg PO daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sunitinib dosing interruptions and/or reductions are allowed based on patient tolerability.
Other Name: Sutent®
- Drug: sorafenib
sorafenib tablets at starting dose of 400 mg PO twice daily, until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. Sorafenib dosing interruptions and/or reductions are allowed based on patient tolerability.
Other Name: Nexavar®
- Cheng AL, Kang YK, Lin DY, Park JW, Kudo M, Qin S, Chung HC, Song X, Xu J, Poggi G, Omata M, Pitman Lowenthal S, Lanzalone S, Yang L, Lechuga MJ, Raymond E. Sunitinib versus sorafenib in advanced hepatocellular cancer: results of a randomized phase III trial. J Clin Oncol. 2013 Nov 10;31(32):4067-75. doi: 10.1200/JCO.2012.45.8372. Epub 2013 Sep 30.
- Koeberle D, Montemurro M, Samaras P, Majno P, Simcock M, Limacher A, Lerch S, Kovàcs K, Inauen R, Hess V, Saletti P, Borner M, Roth A, Bodoky G. Continuous Sunitinib treatment in patients with advanced hepatocellular carcinoma: a Swiss Group for Clinical Cancer Research (SAKK) and Swiss Association for the Study of the Liver (SASL) multicenter phase II trial (SAKK 77/06). Oncologist. 2010;15(3):285-92. doi: 10.1634/theoncologist.2009-0316. Epub 2010 Mar 4.
|December 2011 (Final data collection date for primary outcome measure)|
- Histologically-confirmed diagnosis of hepatocellular carcinoma
- presence of measurable disease by radiographic imaging
- Child-Pugh class A
- ECOG PS 0 or 1
- adequate organ function.
- Prior treatment with any systemic treatment for hepatocellular carcinoma
- prior local treatment within 4 weeks from entry
- presence of clinically relevant ascites
- severe hemorrhage <4 weeks of starting study treatment
- known HIV or serious acute or chronic illness
- current treatment on another clinical trial
- pregnancy or breastfeeding
|Sexes Eligible for Study:||All|
|18 Years and older (Adult, Older Adult)|
|Contact information is only displayed when the study is recruiting subjects|
|Australia, Belgium, Canada, China, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Malaysia, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|