Phase 1b Study of Sorafenib with BIIB022 in Advanced HCC

• Research type

  Research Study

• Full title

  A Phase 1b/2, Open-Label, Randomized Study of Sorafenib With or Without BIIB022 in Subjects With Advanced Hepatocellular Carcinoma. Protocol Number: 212HC201

• IRAS ID

  23575

• Eudract number

  2009-009716-42

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Cancer that begins in the liver is known as primary liver cancer. The leading cause of primary liver cancer is hepatocellular carcinoma (HCC), this cancer begins in the main cells of the liver, which are known as the hepatocytes. The treatment being tested is called BIIB022 and will be used along with or without sorafenib, the current standard treatment for advanced liver cancer. There are two parts to this study, Phase 1b and Phase 2. The Phase 1b part is a 'dose-finding' study and participants with advanced liver cancer will take fixed doses of BIIB022 while also receiving standard doses of sorafenib. The purpose of this part of the study is to find out the best dose of BIIB022 to use in the next phase of the study, this is also known as establishing the Recommended Phase 2 Dose (RP2D). Participants will be assessed regularly to see whether BIIB022 is safe and can be tolerated as a potential treatment for advanced liver cancer. Also in this phase of the study, participants have the option of donating a sample of their tumour tissue for further research. The purpose of the Phase 2 study is compare the response to treatment of participants with advanced liver cancer being given either sorafenib alone or sorafenib combined with the RP2D of BIIB022. All participants in this part of the study will have to donate a sample of their tumour tissue so that research into identifying potential biomarkers for liver cancer can be performed.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  09/H0405/41

• Date of REC Opinion

  5 Oct 2009

• REC opinion

  Further Information Favourable Opinion