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Sorafenib for Imatinib/Sunitinib-failed GIST

NCT01091207 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2012-01-20

No results posted yet for this study

Summary

With discovery of KIT (CD117) mutations and the advent of KIT tyrosine kinase inhibitor imatinib, there has been substantial improvement in overall survival in patients with advanced and/or metastatic gastrointestinal tumors (GIST). Recently, sunitinib showed activity as second-line therapy in GIST patients after failure with imatinib. However, virtually all patients will eventually progress or become intolerable after imatinib and sunitinib. In preclinical models, sorafenib inhibits KIT activity and cell growth of imatinib-resistant tumors. The objective of this multi-center, non-randomized phase II study is to evaluate the safety and activity of sorafenib given as third-line therapy for GIST.

Conditions

Interventions

DRUG

Sorafenib

The patients will receive daily oral administration of sorafenib 400 mg twice daily.

Sponsors & Collaborators

  • Korean GIST Study Group

    collaborator UNKNOWN

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Se Hoon Park, MD · Samsung Medical Center, Seoul, Korea

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-12-31
Completion
2011-08-31

Countries

  • South Korea

Study Locations

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Entities

Drugs
Diseases

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 NCT01091207 on ClinicalTrials.gov