Conditions: Carcinoma, Hepatocellular
Keywords: Hepatocellular carcinoma monoclonal antibody ALK-1 best supportive care
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3
Healthy volunteers: no

Brief summary:
The primary purpose of the study is to explore whether treatment with PF-03446962 and best supportive care is better than placebo plus best supportive care in prolonging survival of patients affected by recurrent liver cancer. In addition, the study will explore if adding PF-03446962 to best supportive care is safe, how PF-03446962 is metabolized, if there are patients' characteristics (biomarkers) that may predict response to PF-03446962, and if PF-03446962 has any effect on the patients' quality of life.

Detailed description:
This study was terminated on June 24th, 2014 due to change in strategy of PF-03446962 clinical development. There were no safety or efficacy concerns regarding the study behind the decision to terminate the trial. The study was on temporary halt since March 10th and there are currently no patients on treatment or in the process of being randomized

Arms:
arm 1: None arm 2: Placebo, IV, every 2 weeks, until disease progression, patient refusal or unacceptable toxicity, whichever occurs first

Interventions: intervention 1: PF-03446962 intervention 2: Best Supportive Care intervention 3: Placebo intervention 4: Best Supportive Care
Intervention descriptions: intervention 1: PF 03446962 7 mg/kg, IV, every 2 weeks, until disease progression, patient refusal or unacceptable toxicity, whichever occurs first intervention 2: BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life intervention 3: Placebo will consist of Saline (0.9% w/v Sodium Chloride Injection, USP or NS) intervention 4: BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.

Protocol document: