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Type(s) of Cancer
Liver
Study Phase
Phase 3
Study Completion Date
December 2011
NCT00699374Uploaded 04-23-2015
Available for Download
PDS UID: Liver_Pfizer_2008_124
A Multinational, Randomized, Open-Label, Phase 3 Study Of Sunitinib Malate Versus Sorafenib In Patients With Advanced Hepatocellular Carcinoma
Provider Information
Provider Data DescriptionThe primary objective of the study was to determine overall survival (OS) of patients with advanced hepatocellular carcinoma (HCC) treated with sunitinib vs. sorafenib. Additional endpoints were PFS, TTP, and safety.
SponsorPfizer
Data ProviderPfizer
Partial set or SubsetOriginal Data
Patients in dataset1074
# of Patients Control544
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/2dm4-k327
CDISC StandardRaw or Case Report Form data
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be given until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of study treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival.
ConditionsCarcinoma, Hepatocellular
Intervention TypeDrug: sunitinib malate
Drug: sorafenib
Drug(s)Drug: sunitinib malate
Drug: sorafenib
Total Enrolled1075
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A - Experimental
Arm B - Active Comparator
Secondary IDN/A
PubMed (PMID)35226112
24081937
20203173
Collaborator(s)N/A
Region(s)United States
Australia
Belgium
Canada
China
France
Germany
Hong Kong
Italy
Japan
Korea, Republic of
Malaysia
Philippines
Poland
Russian Federation
Singapore
South Africa
Spain
Sweden
Taiwan
Thailand
Turkey
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLA6181170 FINAL Protocol 03DEC07.pdf
CRFA6181170_SPA_CRFs_06DEC07.pdf
DATA DICTIONARYA6181170_SPECS.xlsx
DATA (COMPARATOR ARM)adverse.sas7bdat
DATA (COMPARATOR ARM)cd_b_p.sas7bdat
DATA (COMPARATOR ARM)cn_6_p.sas7bdat
DATA (COMPARATOR ARM)cn_7_p.sas7bdat
DATA (COMPARATOR ARM)cn_9_p.sas7bdat
DATA (COMPARATOR ARM)cn_a_p.sas7bdat
DATA (COMPARATOR ARM)condrug.sas7bdat
DATA (COMPARATOR ARM)contrt.sas7bdat
DATA (COMPARATOR ARM)demog.sas7bdat
DATA (COMPARATOR ARM)ecg.sas7bdat
DATA (COMPARATOR ARM)final.sas7bdat
DATA (COMPARATOR ARM)iota_p.sas7bdat
DATA (COMPARATOR ARM)lab_safe.sas7bdat
DATA (COMPARATOR ARM)pfm_p.sas7bdat
DATA (COMPARATOR ARM)phyexam.sas7bdat
DATA (COMPARATOR ARM)prevdis.sas7bdat
DATA (COMPARATOR ARM)primdiag.sas7bdat
DATA (COMPARATOR ARM)random.sas7bdat
DATA (COMPARATOR ARM)srv_p.sas7bdat
DATA (COMPARATOR ARM)testdrug.sas7bdat
DATA (COMPARATOR ARM)tmm_p.sas7bdat
DATA (COMPARATOR ARM)vitals.sas7bdat
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