Clinical Trials Directory

Trials / Completed

CompletedNCT01158287

Sorafenib. ICORG 06-41, V4

Phase II Study of Single Agent Sorafenib in the Treatment of Relapsed Esophageal/Gastric Adenocarcinoma in Platinum Pre-Treated Patients

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
54 (estimated)
Sponsor
Cancer Trials Ireland · Network
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sorafenib tosylate works in treating patients with relapsed esophageal cancer and/or stomach cancer.

Detailed description

OBJECTIVES: Primary * To determine the disease control rate (complete response, partial response, and stable disease) of sorafenib tosylate after 4 months in patients with relapsed esophageal or gastric adenocarcinoma previously treated with platinum-based chemotherapy. Secondary * To determine the progression-free survival of patients treated with this drug. * To determine the overall survival of patients treated with this drug. * To determine the time to tumor progression in patients treated with this drug. * To determine the objective response rate in patients treated with this drug. * To determine the tolerability and toxicity in patients treated with this drug. * To assess biomarkers associated with response/resistance to therapy. (exploratory) OUTLINE: This is a multicenter study. Patients receive oral sorafenib tosylate twice a day on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Blood and tumor samples may be collected periodically and analyzed for biological markers. After completion of study treatment, patients are followed up periodically.

Conditions

Interventions

TypeNameDescription
DRUGsorafenib tosylate
OTHERlaboratory biomarker analysis

Timeline

Start date
2009-02-01
Primary completion
2012-11-01
First posted
2010-07-08
Last updated
2014-12-31

Locations

8 sites across 1 country: Ireland

Source: ClinicalTrials.gov record NCT01158287. Inclusion in this directory is not an endorsement.