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
NCT ID: NCT01911273
Last Updated: 2015-10-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
3 participants
INTERVENTIONAL
2013-10-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PF 03446962 plus best supportive care (BSC)
PF-03446962
PF 03446962 7 mg/kg, IV, every 2 weeks, until disease progression, patient refusal or unacceptable toxicity, whichever occurs first
Best Supportive Care
BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life
Placebo plus best supportive care (BSC)
Placebo, IV, every 2 weeks, until disease progression, patient refusal or unacceptable toxicity, whichever occurs first
Placebo
Placebo will consist of Saline (0.9% w/v Sodium Chloride Injection, USP or NS)
Best Supportive Care
BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.
Interventions
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PF-03446962
PF 03446962 7 mg/kg, IV, every 2 weeks, until disease progression, patient refusal or unacceptable toxicity, whichever occurs first
Best Supportive Care
BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life
Placebo
Placebo will consist of Saline (0.9% w/v Sodium Chloride Injection, USP or NS)
Best Supportive Care
BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.
Eligibility Criteria
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Inclusion Criteria
* 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 local therapy within 2 weeks of starting the study treatment
* Presence of main portal vein invasion by liver cancer
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Kinki University Hospital, Department of Gastroenterology and Hepatology
Ōsaka-sayama, Osaka, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2013-001426-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A8471005
Identifier Type: -
Identifier Source: org_study_id
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