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

Phase 2
18 Years
Not Enrolling
Gastrointestinal Stromal Tumors

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Trial Information

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

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).

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-control rate

Outcome Time Frame:

Six months after registration

Safety Issue:


Principal Investigator

Se Hoon Park, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center, Seoul, Korea


South Korea: Korea Food and Drug Administration (KFDA)

Study ID:




Start Date:

November 2009

Completion Date:

August 2011

Related Keywords:

  • Gastrointestinal Stromal Tumors
  • Sorafenib
  • GIST
  • Refractory
  • advanced GIST failed after both imatinib and sunitinib
  • Gastrointestinal Stromal Tumors