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Liver

A Multinational, Randomized, Open-Label, Phase 3 Study of Sunitinib Malate Versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma

Unique Data Set IDLiver_Pfizer_2008_124
DownloadableYes
SponsorPfizerData ProviderPfizerTotal Study Enrolled Patients1074Comparator (Control) Arm Enrolled Patients544RandomizationYesClinicalTrial.gov IDNCT00699374ClinicalTrial.gov URLhttps://clinicaltrials.gov/show/NCT00699374
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeDrugData Set TypeSDTM

Clinical Trial Title

A Multinational, Randomized, Open-Label, Phase 3 Study of Sunitinib Malate Versus Sorafenib in Patients with Advanced Hepatocellular Carcinoma

Trial Summary and Conditions

The primary objective of the study was to determine overall survival (OS) of patients with advanced hepatocellular carcinoma (HCC) treated with sunitinib vs. sorafenib. The study was designed to A total enrolled 1200 patients , 600 per arm, and treatment was to continue until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria were met.

Data Summary

A total of 1074 subjects were assigned to study treatment. A total of 1068 (99.4%) subjects were treated (526 received sunitinib and 542 received sorafenib). Six subjects were assigned to study treatment (4 to sunitinib and 2 to sorafenib, respectively), but were not treated. Most subjects were male (83.3%). The mean age of subjects was 58.3 years (range, 18 to 85 years). Most subjects were Asian (77.2%), followed by white (20.8%). Overall, demographic characteristics were similar between treatment arms. There were no differences between treatment arms in demographics including age, sex, race, weight, or height. The median time to death was 34.3 weeks for sunitinib, with a 95% CI of (31.9, 39.9). The median time to death was 43.9 weeks for sorafenib, with a 95% CI of (38.1, 48.7). The hazard ratio was 1.3 (sunitinib vs sorafenib), with a 95% CI of (1.1, 1.5). p-value = 0.9993. The frequency of AEs was higher and severity of AEs was greater with sunitinib than sorafenib. This study was terminated early on April 22th, 2010, based on a higher incidence of serious adverse events in the sunitinib arm compared to the sorafenib arm, and the fact that sunitinib did not meet the criteria to demonstrate superiority or non-inferiority in OS.

Study Objectives

The 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.

Outcome Measures

• Overall Survival • Progression-Free Survival (PFS) • The period from randomization until disease progression or death. • Time to Tumor Progression (TTP) Time in weeks from randomization to first documentation of objective tumor progression or death due to cancer, whichever comes first. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD])

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: A6181170 FINAL Protocol 03DEC07.pdf

CRF: A6181170_SPA_CRFs_06DEC07.pdf

DATA DICTIONARY: A6181170_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