Sorafenib for Imatinib/Sunitinib-failed GIST

January 18, 2012 updated by: Samsung Medical Center

A Phase II Study of Sorafenib in Patients With Metastatic or Advanced Gastrointestinal Stromal Tumors Who Failed to Imatinib and Sunitinib

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a non-randomized, open-label, multi-center, phase II study recruiting patients with advanced GIST who are pretreated with both imatinib and sunitinib. The current study will provide an estimate of the activity and safety of sorafenib in GIST. The primary study endpoint is the disease control rate (DCR), defined as complete or partial response or stable disease of at least 24 weeks of sorafenib therapy. Secondary endpoints include PFS, OS and safety.

Patients with advanced (unresectable and/or metastatic) GIST who failed after previous therapy involving both imatinib and sunitinib will be eligible. Failure to imatinib and sunitinib is defined as disease progression regardless of intervening response during therapy, or intolerance. There is no limit to the number of prior therapies a patient may have received (e.g., patients may have received therapy with nilotinib, other TKIs, or chemotherapy in addition to imatinib or sunitinib).

Study Type

Interventional

Enrollment (Anticipated)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age over 18 years
  • advanced GIST
  • failed (progressed and/or intolerable) after prior treatments for GIST
  • ECOG performance status of 0~2
  • resolution of all toxic effects of prior treatments
  • no prior radiotherapy within 1 month before registration
  • measurable lesion as defined by RECIST
  • adequate marrow, hepatic, renal and cardiac functions
  • provision of a signed written informed consent

Exclusion Criteria:

  • severe co-morbid illness and/or active infections
  • pregnant or lactating women
  • history of other malignancies
  • active CNS disease not controllable with radiotherapy or corticosteroids
  • active and uncontrollable bleeding from gastrointestinal tract
  • prior history of sorafenib use
  • gastrointestinal obstruction or malabsorption syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sorafenib
The patients will receive daily oral administration of sorafenib 400 mg twice daily.
Drug: Sorafenib
The patients will receive daily oral administration of sorafenib 400 mg twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease-control rate
Time Frame: Six months after registration
Six months after registration

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate
Time Frame: Every 2 months
Every 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Korean GIST Study Group

Investigators

  • Principal Investigator: Se Hoon Park, MD, Samsung medical center, Seoul, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

November 30, 2009

First Submitted That Met QC Criteria

March 22, 2010

First Posted (Estimate)

March 23, 2010

Study Record Updates

Last Update Posted (Estimate)

January 20, 2012

Last Update Submitted That Met QC Criteria

January 18, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-08-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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