Status:
TERMINATED
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
Lead Sponsor:
Pfizer
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
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 termina...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01911273
Start Date
October 1 2013
End Date
July 1 2014
Last Update
October 28 2015
Active Locations (4)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
2
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277-8577
3
Kinki University Hospital, Department of Gastroenterology and Hepatology
Ōsaka-sayama, Osaka, Japan, 589-8511
4
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045