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

November 30, 2009
March 23, 2010
January 20, 2012
November 2009
December 2010   (Final data collection date for primary outcome measure)
Disease-control rate [ Time Frame: Six months after registration ]
Same as current
Complete list of historical versions of study NCT01091207 on Archive Site
Response rate [ Time Frame: Every 2 months ]
Same as current
Not Provided
Not Provided
Sorafenib for Imatinib/Sunitinib-failed GIST
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.

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).

Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastrointestinal Stromal Tumors
Drug: Sorafenib
The patients will receive daily oral administration of sorafenib 400 mg twice daily.
Experimental: Sorafenib
The patients will receive daily oral administration of sorafenib 400 mg twice daily.
Intervention: Drug: Sorafenib
Park SH, Ryu MH, Ryoo BY, Im SA, Kwon HC, Lee SS, Park SR, Kang BY, Kang YK. Sorafenib in patients with metastatic gastrointestinal stromal tumors who failed two or more prior tyrosine kinase inhibitors: a phase II study of Korean gastrointestinal stromal tumors study group. Invest New Drugs. 2012 Dec;30(6):2377-83. doi: 10.1007/s10637-012-9795-9. Epub 2012 Jan 25.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
August 2011
December 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
Not Provided
Not Provided
Se Hoon Park, Samsung Medical Center, Seoul, Korea
Samsung Medical Center
Korean GIST Study Group
Principal Investigator: Se Hoon Park, MD Samsung Medical Center, Seoul, Korea
Samsung Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP