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Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma

NCT01210495 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2019-01-09

Study results available
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Summary

The study is designed to demonstrate that axitinib plus best supportive care is superior to placebo plus best supportive care in prolonging survival in patients with advanced hepatocellular carcinoma.

Conditions

Interventions

DRUG

Axitinib (AG-013736)

Axitinib \[tablet, 1 mg, 5 mg\] will be given twice daily \[BID\] with continuous dosing; duration is approximately 3-6 months; starting dose is 5 mg BID

OTHER

Best Supportive Care

BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.

DRUG

Placebo

Placebo \[tablet, 1 mg, 5 mg\] will be given twice daily \[BID\] with continuous dosing; duration is approximately 3-6 months; starting dose is 5 mg BID

OTHER

Best Supportive Care

BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-06
Primary Completion
2014-03-03
Completion
2016-12-20

Countries

  • United States
  • Belgium
  • China
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Japan
  • Slovakia
  • South Korea
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01210495 on ClinicalTrials.gov