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Sorafenib With Capecitabine for Patients With Measurable Hepatocellular Carcinoma

NCT01032850 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2021-06-02

Study results available
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Summary

This research study will evaluate Sorafenib (Nexavar®) and Capecitabine (Xeloda®) to see the following:

* how effective this combination of study drugs will be in treating HCC
* how long subjects respond to these study drugs
* what types of side effects can be expected, and
* how severe the side effects are

All subjects in this study will receive:

* Sorafenib twice a day by mouth
* Capecitabine twice a day by mouth

Treatment will be given in a 28-day treatment cycle.

Subjects will take sorafenib every day of the cycle. Subjects will take capecitabine on days 1-7 and 15-21 of the cycle

Conditions

Interventions

DRUG

Sorafenib & Capecitabine

Intervention: Sorafenib twice a day by mouth (400mg), Capecitabine twice a day by mouth (850mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • New Mexico Cancer Research Alliance

    lead OTHER

Principal Investigators

  • Yehuda Z. Patt, MD · University of New Mexico Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-05-31
Completion
2017-08-31

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 NCT01032850 on ClinicalTrials.gov