NCT01911273

A Study To Evaluate The Efficacy And Safety of The Investigational Drug PF-03446962 (A Monoclonal Antibody With Antiangiogenic Features) In Combination With Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients Affected By Recurrent Liver Cancer

A Phase 2, Randomized, Double Blind Study To Evaluate The Efficacy, Safety, Pharmacodynamics And Pharmacokinetics Of The Anti-alk-1 Monoclonal Antibody Pf-03446962 In Combination With Best Supportive Care Vs. Placebo Plus Best Supportive Care In Adult Patients With Advanced Hepatocellular Carcinoma Following Failure Of Sorafenib

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Carcinoma, Hepatocellular

Interventions

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

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2013-07-30
• Last updated: 2015-10-28
• Results posted: 2015-06-29

Locations

4 sites across 2 countries: United States, Japan