Overview

This trial is active, not recruiting.

Condition hepatocellular carcinoma
Treatments axitinib (ag-013736), best supportive care, placebo
Phase phase 2
Sponsor Pfizer
Start date December 2010
End date March 2014
Trial size 222 participants
Trial identifier NCT01210495, A4061058

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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
best supportive care
BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.
(Placebo Comparator)
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
best supportive care
BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.

Primary Outcomes

Measure
Overall Survival
time frame: 2 years

Secondary Outcomes

Measure
Progression-Free Survival
time frame: 1 year
Time to Tumor Progression
time frame: 1 year
Overall Response Rate
time frame: 1 year
Duration of Response
time frame: 1 year
Clinical Benefit Response: the proportion of patients with confirmed CR or confirmed PR or a best response of stable disease (SD) ≥ 8 weeks according to RECIST.
time frame: 1 year
Type, incidence, severity, timing, seriousness, and relatedness of adverse events, laboratory abnormalities based upon the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE]
time frame: 2 years
Plasma PK and tolerability of single agent axitinib following continuous dosing [Non-randomized portion], and axitinib population pharmacokinetic analysis [Randomized portion]
time frame: 1 year
Patient Reported Outcome (PRO) of health-related quality of life and disease-related symptoms as measured by the Functional Assessment of Cancer Therapy-Hepatobiliary questionnaire and health status measured by the EuroQol EQ-5D Self-Report
time frame: 2 years
Questionnaire
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Locally advanced or metastatic HCC - Failure of one prior antiangiogenic therapy including sorafenib, bevacizumab and brivanib. - Child-Pugh Class A or B (score 7 only) disease. Exclusion Criteria: - Prior treatment of advanced HCC with more than one prior first-line systemic therapy. - Any prior local therapy within 2 weeks of starting the study treatment. - Presence of hepatic encephalopathy and/or clinically relevant ascites. - Presence of main portal vein invasion by HCC.

Additional Information

Official title A Multicenter, Global, Randomized, Double-Blind Study Of Axitinib Plus Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients With Advanced Hepatocellular Carcinoma Following Failure Of One Prior Antiangiogenic Therapy
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Pfizer.