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Sorafenib for Imatinib/Sunitinib-failed GIST

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01091207
Recruitment Status : Completed
First Posted : March 23, 2010
Last Update Posted : January 20, 2012
Korean GIST Study Group
Information provided by:
Samsung Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumors Drug: Sorafenib Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Sorafenib in Patients With Metastatic or Advanced Gastrointestinal Stromal Tumors Who Failed to Imatinib and Sunitinib
Study Start Date : November 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : August 2011

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.

Primary Outcome Measures :
  1. Disease-control rate [ Time Frame: Six months after registration ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: Every 2 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01091207

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Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135710
Sponsors and Collaborators
Samsung Medical Center
Korean GIST Study Group
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Principal Investigator: Se Hoon Park, MD Samsung Medical Center, Seoul, Korea
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Se Hoon Park, Samsung Medical Center, Seoul, Korea Identifier: NCT01091207    
Other Study ID Numbers: 2009-08-102
First Posted: March 23, 2010    Key Record Dates
Last Update Posted: January 20, 2012
Last Verified: January 2012
Keywords provided by Samsung Medical Center:
advanced GIST failed after both imatinib and sunitinib
Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action