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Sunitinib Malate (SUO11248) In Subjects W/ Metastatic And/Or Surgically Unresectable Hepatocellular Cancers (HCC)

NCT00495625 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2012-03-27

Study results available
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Summary

An open label multi-site phase II clinical trial of dose escalated sunitinib malate given orally once daily on days 1-28 of each 42-day cycle. Treatment will be continued until there is either disease progression or cumulative or acute toxicity which in the opinion of the treating physician compromises the ability of the patient to receive treatment or patient desire to stop treatment.

Conditions

Interventions

DRUG

Sunitinib Malate

Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles will be 37.5 mg daily for 28 days, every 42 days. Dose may be escalated to 50 mg daily for 28 days at the treating investigator's discretion.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jonathan Strosberg, MD · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00495625 on ClinicalTrials.gov