Axitinib plus BSC v Placebo plus BSC in Advanced HCC Patients

• Research type

  Research Study

• Full title

  A MULTICENTER, GLOBAL, RANDOMIZED, DOUBLE-BLIND STUDY OF AXITINIB PLUS BEST SUPPORTIVE CARE VERSUS PLACEBO PLUS BEST SUPPORTIVE CARE IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCINOMA FOLLOWING FAILURE OF ONE PRIOR ANTIANGIOGENIC THERAPY

• IRAS ID

  72381

• Contact name

  Tim Meyer

• Sponsor organisation

  Pfizer Inc 235 East 42nd Street, New York, NY10017

• Eudract number

  2010-021590-37

• ISRCTN Number

  isrctn

• Research summary

  This research study involves subjects with advanced hepatocellular carcinoma (HCC), commonly known as liver cancer. The main purpose of the study is to see whether patients taking axitinib best supportive care live longer than patients taking placebo best supportive care. Currently there is no standard effective treatment given for this patient population therefore axitinib will be evaluated versus placebo. Eligible subjects must have a diagnosis of HCC. Subjects will sign an informed consent form before any tests are done. Each subject's suitability for the study will be assessed during a screening visit. The objectives will be assessed throughout the study by Physician assessments of the patients HCC, and subjects assessments of outcomes by completing questionnaires related to HCC quality of life, physical examinations, vital signs, electrocardiograms and blood tests. Subjects will be randomized or assigned by chance (like the flip of a coin) to receive either axitinib or placebo (a pill that does not contain active drug). They will have a 66.6% (2 in 3) chance of receiving axitinib, and a 33.3% (1 in 3) chance of receiving placebo. Subjects will continue in this study as long as their disease is responding to treatment and they are tolerating the treatment. Subjects who complete the treatment period or withdraw from the study prior to completion will have a follow up visit completed 28 days after their last dose of study drug. After the follow-up visit subjects will be contacted by telephone every 3 months for at least 3 years and will be asked about any changes in their health or medications and treatments.

• REC name

  London - Central Research Ethics Committee

• REC reference

  11/LO/0449

• Date of REC Opinion

  23 Jun 2011

• REC opinion

  Further Information Favourable Opinion