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 Recurr

• Status: Terminated
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Antibodies; Antibodies, Monoclonal; Immunoglobulins

Criteria

Inclusion Criteria:

• Diagnosis of locally advanced or metastatic liver cancer obtained by histology/cytology or by imaging

• Documented progression on or after treatment with sorafenib, confirmed by the Investigator upon review of appropriate imaging documentation

• Child Pugh Class A disease

• ECOG [Eastern Cooperative Oncology Group] Performance Status (PS) 0 or 1

• Mandatory tumor biopsy at study entry (pre-randomization, unless already collected after sorafenib progression but within 3 months of enrollment and no systemic anticancer therapies received)

Exclusion Criteria:

• Prior systemic treatment for advanced liver cancer other than sorafenib-including therapy

• Prior local therapy within 2 weeks of starting the study treatment

• Presence of main portal vein invasion by liver cancer